Documents > NDA

Per Page: 152550
NDA S detailed view
From: FDADocs | Date: 5/9/2008 | Rated: 0 (0) | Views: 30 | Downloads: 0
Add to My Docs

NDA 20-154/S-050 NDA 20-155/S-039 NDA 20-156/S-040 NDA 21-183/S-016 Patient Information Rx only VIDEX® (generic name = didanosine also known as ddI) VIDEX (didanosine) Pediatric Powder for Oral Solution ® What is VIDEX? VIDEX (pronounced VY dex) is a prescription medicine used in combination with other drugs to treat children and adults who are  ...  more>>

Tags: food and drug administration, FDA, FDA documents, FDA reports, FDA approval, FDA regulations, FDA recall, food safety, FDA news, department of public safety
Categories: legal > Government >
Views: 30
Downloads: 0
Language: English
NDA NDA Page by CFR part A general
From: FDADocs | Date: 5/8/2008 | Rated: 0 (0) | Views: 31 | Downloads: 0
Add to My Docs

NDA 20-732 NDA 20-733 Page 43 by 42 CFR part 2. A general authorization for the release of medical or other information is NOT sufficient for this purpose. Information for Pharmacists SUBOXONE® (buprenorphine HCl/naloxone HCl dihydrate, sublingual tablet) and SUBUTEX® (buprenorphine HCl, sublingual tablet) What are SUBOXONE and SUBUTEX? SUBOXONE ...  more>>

Tags: food and drug administration, FDA, FDA documents, FDA reports, FDA approval, FDA regulations, FDA recall, food safety, FDA news, department of public safety
Categories: legal > Government >
Views: 31
Downloads: 0
Language: English
NDA S NDA S Page Patient Information Rx detailed view
From: FDADocs | Date: 5/9/2008 | Rated: 0 (0) | Views: 35 | Downloads: 0
Add to My Docs

NDA 21-797/S-002 NDA 21-798/S-002 Page 28 Patient Information Rx only Baraclude® (BEAR ah klude) (generic name = entecavir) Tablets and Oral Solution Read the Patient Information that comes with BARACLUDE before you start taking it and each time you get a refill. There may be new information. This information does not take the place of talking w ...  more>>

Tags: food and drug administration, FDA, FDA documents, FDA reports, FDA approval, FDA regulations, FDA recall, food safety, FDA news, department of public safety
Categories: legal > Government >
Views: 35
Downloads: 0
Language: English
NDA S NDA S Page Rev February KETEK detailed view
From: FDADocs | Date: 5/9/2008 | Rated: 0 (0) | Views: 36 | Downloads: 0
Add to My Docs

NDA 21-144/S-001 NDA 21-144/S-003 Page 3 Rev. February 2005 KETEK® (telithromycin) Tablets To reduce the development of drug-resistant bacteria and maintain the effectiveness of KETEK and other antibacterial drugs, KETEK should be used only to treat infections that are proven or strongly suspected to be caused by bacteria. DESCRIPTION KETEK® table ...  more>>

Tags: food and drug administration, FDA, FDA documents, FDA reports, FDA approval, FDA regulations, FDA recall, food safety, FDA news, department of public safety
Categories: legal > Government >
Views: 36
Downloads: 0
Language: English
NDA S NDA S Page Patient Information TAMIFLU 2006
From: FDADocs | Date: 5/9/2008 | Rated: 0 (0) | Views: 25 | Downloads: 0
Add to My Docs

NDA 21-087/S-033 NDA 21-246/S-021 Page 23 Patient Information TAMIFLU® (oseltamivir phosphate) RX ONLY This leaflet contains important information about TAMIFLU (TAM-ih-flew). Read it well before you begin treatment. This information does not take the place of talking with your healthcare professional about your medical condition or your treatment ...  more>>

Tags: food and drug administration, FDA, FDA documents, FDA reports, FDA approval, FDA regulations, FDA recall, food safety, FDA news, department of public safety
Categories: legal > Government >
Views: 25
Downloads: 0
Language: English
NDA S NDA S Page Patient Information About detailed view
From: FDADocs | Date: 5/9/2008 | Rated: 0 (0) | Views: 40 | Downloads: 0
Add to My Docs

NDA 20-628/S-024 NDA 21-785/S-003 Page 31 Patient Information About INVIRASE (in-ver-ase) INVIRASE® (saquinavir mesylate) CAPSULES and TABLETS Generic Name: Saquinavir mesylate (sa-KWIN-a-veer mes-il-late) Rx only ALERT: Find out about medicines that should NOT be taken with INVIRASE. Please also read the section MEDICINES YOU SHOULD NOT TAKE WI ...  more>>

Tags: food and drug administration, FDA, FDA documents, FDA reports, FDA approval, FDA regulations, FDA recall, food safety, FDA news, department of public safety
Categories: legal > Government >
Views: 40
Downloads: 0
Language: English
NDA S NDA S Page GlaxoSmithKline Research Triangle detailed view
From: FDADocs | Date: 5/9/2008 | Rated: 0 (0) | Views: 36 | Downloads: 0
Add to My Docs

NDA 21-003/S-010 NDA 21-004/S-010 Page 18 GlaxoSmithKline Research Triangle Park, NC 27709 Manufactured under agreement from Shire Pharmaceuticals Group plc Basingstoke, UK ©2007, GlaxoSmithKline All rights reserved. Date of Issue RL- PHARMACIST-DETACH HERE AND GIVE INSTRUCTIONS TO PATIENT _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ ...  more>>

Tags: food and drug administration, FDA, FDA documents, FDA reports, FDA approval, FDA regulations, FDA recall, food safety, FDA news, department of public safety
Categories: legal > Government >
Views: 36
Downloads: 0
Language: English
NDA S NDA S Page REYATAZ Rx only detailed view
From: FDADocs | Date: 5/9/2008 | Rated: 0 (0) | Views: 33 | Downloads: 0
Add to My Docs

NDA 21-567/S-008 NDA 21-567/S-011 Page 3 REYATAZ ® Rx only (atazanavir sulfate) Capsules (Patient Information Leaflet Included) DESCRIPTION REYATAZ (atazanavir sulfate) is an azapeptide inhibitor of HIV-1 protease. The chemical name for atazanavir sulfate is (3S,8S,9S,12S)-3,12-Bis(1,1-dimethylethyl)-8hydroxy-4,11-dioxo-9-(phenylmethyl)-6-[[4- ...  more>>

Tags: food and drug administration, FDA, FDA documents, FDA reports, FDA approval, FDA regulations, FDA recall, food safety, FDA news, department of public safety
Categories: legal > Government >
Views: 33
Downloads: 0
Language: English
NDA S NDA S Page MACUGEN pegaptanib sodium 2006
From: FDADocs | Date: 5/9/2008 | Rated: 0 (0) | Views: 27 | Downloads: 0
Add to My Docs

NDA 21-756/S-006 NDA 21-756/S-007 Page 3 MACUGEN® (pegaptanib sodium injection) DESCRIPTION MACUGEN® (pegaptanib sodium injection) is a sterile, aqueous solution containing pegaptanib sodium for intravitreous injection. Macugen is supplied in a single-dose, pre-filled syringe and is formulated as a 3.47 mg/mL solution, measured as the free acid fo ...  more>>

Tags: food and drug administration, FDA, FDA documents, FDA reports, FDA approval, FDA regulations, FDA recall, food safety, FDA news, department of public safety
Categories: legal > Government >
Views: 27
Downloads: 0
Language: English
NDA S NDA S Package Insert Page PHYSICIANS detailed view
From: FDADocs | Date: 5/9/2008 | Rated: 0 (0) | Views: 75 | Downloads: 0
Add to My Docs

NDA 19-653/S-037 NDA 19-697/S-034 Package Insert Page 1 PHYSICIANS' PACKAGE INSERT ORTHO TRI-CYCLEN® TABLETS ORTHO-CYCLEN® TABLETS (norgestimate/ethinyl estradiol) Patients should be counseled that this product does not protect against HIV infection (AIDS) and other sexually transmitted diseases. DESCRIPTION Each of the following products is a comb ...  more>>

Tags: food and drug administration, FDA, FDA documents, FDA reports, FDA approval, FDA regulations, FDA recall, food safety, FDA news, department of public safety
Categories: legal > Government >
Views: 75
Downloads: 0
Language: English
NDA S NDA S Page NEXIUM I V detailed view
From: FDADocs | Date: 5/9/2008 | Rated: 0 (0) | Views: 30 | Downloads: 0
Add to My Docs

NDA 21-153/S-027 NDA 21-689/S-008 Page 28 NEXIUM® I.V. (esomeprazole sodium) for Injection Rx only DESCRIPTION The active ingredient in NEXIUM® I.V. (esomeprazole sodium) for Injection is (S)-5-methoxy-2[[(4methoxy-3,5-dimethyl-2-pyridinyl)-methyl]sulfinyl]-1 H-benzimidazole sodium a compound that inhibits gastric acid secretion. Esomeprazole is t ...  more>>

Tags: food and drug administration, FDA, FDA documents, FDA reports, FDA approval, FDA regulations, FDA recall, food safety, FDA news, department of public safety
Categories: legal > Government >
Views: 30
Downloads: 0
Language: English
NDA S NDA S Rev XXX ARAVA Tablets 2003
From: FDADocs | Date: 5/9/2008 | Rated: 0 (0) | Views: 43 | Downloads: 0
Add to My Docs

NDA 20-905/S-006 NDA 20-905/S-007 Rev. XXX ARAVA Tablets (leflunomide) 10 mg, 20 mg, 100 mg Rx only CONTRAINDICATIONS AND WARNINGS PREGNANCY MUST BE EXCLUDED BEFORE THE START OF TREATMENT WITH ARAVA. ARAVA IS CONTRAINDICATED IN PREGNANT WOMEN, OR WOMEN OF CHILDBEARING POTENTIAL WHO ARE NOT USING RELIABLE CONTRACEPTION. (SEE CONTRAINDICATIONS AND W ...  more>>

Tags: food and drug administration, FDA, FDA documents, FDA reports, FDA approval, FDA regulations, FDA recall, food safety, FDA news, department of public safety
Categories: legal > Government >
Views: 43
Downloads: 0
Language: English
NDA S NDA S Page Rev ARAVA detailedview
From: FDADocs | Date: 5/9/2008 | Rated: 0 (0) | Views: 23 | Downloads: 0
Add to My Docs

NDA 20-905/S-006 NDA 20-905/S-007 Page 4 Rev. XXX ARAVA Tablets (leflunomide) 10 mg, 20 mg, 100 mg Rx only CONTRAINDICATIONS AND WARNINGS PREGNANCY MUST BE EXCLUDED BEFORE THE START OF TREATMENT WITH ARAVA. ARAVA IS CONTRAINDICATED IN PREGNANT WOMEN, OR WOMEN OF CHILDBEARING POTENTIAL WHO ARE NOT USING RELIABLE CONTRACEPTION. (SEE CONTRAINDICATION ...  more>>

Tags: food and drug administration, FDA, FDA documents, FDA reports, FDA approval, FDA regulations, FDA recall, food safety, FDA news, department of public safety
Categories: legal > Government >
Views: 23
Downloads: 0
Language: English
NDA S NDA S Page NEXIUM esomeprazole magnesium detailed view
From: FDADocs | Date: 5/9/2008 | Rated: 0 (0) | Views: 46 | Downloads: 1
Add to My Docs

NDA 21-153/S-027 NDA 21-689/S-008 Page 3 NEXIUM® (esomeprazole magnesium) DELAYED-RELEASE CAPSULES NEXIUM® (esomeprazole magnesium) FOR DELAYED-RELEASE ORAL SUSPENSION Rx only DESCRIPTION The active ingredient in NEXIUM® (esomeprazole magnesium) Delayed-Release Capsules and NEXIUM (esomeprazole magnesium) For Delayed-Release Oral Suspension is bi ...  more>>

Tags: food and drug administration, FDA, FDA documents, FDA reports, FDA approval, FDA regulations, FDA recall, food safety, FDA news, department of public safety
Categories: legal > Government >
Views: 46
Downloads: 1
Language: English
NDA S NDA S Page Patient Information EMTRIVA detailed view
From: FDADocs | Date: 5/9/2008 | Rated: 0 (0) | Views: 39 | Downloads: 0
Add to My Docs

NDA 21-896/S-001 NDA 21-500/S-007 Page 24 Patient Information EMTRIVA® (em-treev’-ah) Capsules EMTRIVA Oral Solution Generic name: emtricitabine (em tri SIT uh bean) Read the Patient Information that comes with EMTRIVA before you start using it and each time you get a refill. There may be new information. This information does not take the place o ...  more>>

Tags: food and drug administration, FDA, FDA documents, FDA reports, FDA approval, FDA regulations, FDA recall, food safety, FDA news, department of public safety
Categories: legal > Government >
Views: 39
Downloads: 0
Language: English
Per Page: 152550
View All Categories

all documents