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NDA S NDA S Page NEXIUM I V detailed view

FDADocs 5/9/2008 | 0 (0) | 21 | 0 | 0 | English

NDA 21-153/S-027 NDA 21-689/S-008 Page 28NEXIUM?? I.V.(esomeprazole sodium) for Injection Rx only DESCRIPTION The active ingredient in NEXIUM?? I.V. (esomeprazole sodium) for Injection is (S  ... more>>

NDA S NDA S Rev XXX ARAVA Tablets 2003

FDADocs 5/9/2008 | 0 (0) | 28 | 0 | 0 | English

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  ... more>>

NDA S NDA S Page Rev ARAVA detailedview

FDADocs 5/9/2008 | 0 (0) | 16 | 0 | 0 | English

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  ... more>>

NDA S NDA S Page NEXIUM esomeprazole magnesium detailed view

FDADocs 5/9/2008 | 0 (0) | 25 | 0 | 0 | English

NDA 21-153/S-027 NDA 21-689/S-008 Page 3NEXIUM??(esomeprazole magnesium) DELAYED-RELEASE CAPSULESNEXIUM??(esomeprazole magnesium) FOR DELAYED-RELEASE ORAL SUSPENSION Rx only DESCRIPTION  ... more>>

NDA S NDA S Page Patient Information EMTRIVA detailed view

FDADocs 5/9/2008 | 0 (0) | 25 | 0 | 0 | English

NDA 21-896/S-001 NDA 21-500/S-007 Page 24Patient Information EMTRIVA?? (em-treev???-ah) Capsules EMTRIVA Oral Solution Generic name: emtricitabine (em tri SIT uh bean) Read the Patient  ... more>>

NDA S NDA S January Page TAMIFLU oseltamivir 2008

FDADocs 5/9/2008 | 0 (0) | 16 | 0 | 0 | English

NDA 21-087/S-042 NDA 21-246/S-030 January 17, 2008 Page 3TAMIFLU?? (oseltamivir phosphate) CAPSULES AND FOR ORAL SUSPENSION Rx only DESCRIPTION TAMIFLU (oseltamivir phosphate) is available as  ... more>>

NDA S NDA S Page CELEBREX celecoxib capsules detailed view

FDADocs 5/9/2008 | 0 (0) | 14 | 0 | 0 | English

NDA 20-998/S-018 NDA 20-998/S-019 Page 3 CELEBREX?? celecoxib capsules Cardiovascular Risk ??? CELEBREX may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction  ... more>>

NDA S NDA S Page PRESCRIBING INFORMATION EPIVIR detailed view

FDADocs 5/9/2008 | 0 (0) | 22 | 0 | 0 | English

NDA 21-003/S-010 NDA 21-004/S-010 Page 3PRESCRIBING INFORMATIONEPIVIR-HBV(lamivudine) Tablets??EPIVIR-HBV??(lamivudine) Oral SolutionWARNING LACTIC ACIDOSIS AND SEVERE  ... more>>

NDA S NDA S Approved Labeling Text dated 2001

FDADocs 5/9/2008 | 0 (0) | 12 | 0 | 0 | English

NDA 20-505/S-002 NDA 20-844/S-010 Approved Labeling Text dated 08/28/01 Page 6WARNINGS Acute myopia and secondary angle closure glaucoma A syndrome consisting of acute myopia associated with  ... more>>

NDA for Evaluation - TEMPLATE

pjgriffith 4/8/2008 | 0 (0) | 71 | 2 | 0 | English

???1???COMPANY NAME[ADDRESS] [ADDRESS]_______________, 200_ CONFIDENTIAL Company / Person Name. [ADDRESS] [ADDRESS] Tel: Email: Attention: [NAME] Dear [NAME]: Confidentia...  ... more>>

Memorandum to File To NDA file From S

FDADocs 5/9/2008 | 0 (0) | 9 | 0 | 0 | English

Memorandum to FileTo: NDA 21-210 file From: S. Markofsky (Acting Team Leader) Subject: Storage... labeling provided in NDA 21-210 for their Levothyroxine Sodium (Tablets), Jerome Sevens Pharmaceutical's  ... more>>

NDA S NDA S Page REYATAZ Rx only

GovernmentDocs 5/5/2008 | 0 (0) | 19 | 0 | 0 | English

NDA 21-567/S-008 NDA 21-567/S-011 Page 3REYATAZ??Rx only(atazanavir sulfate) Capsules (Patient Information Leaflet Included)DESCRIPTIONREYATAZ (atazanavir sulfate) is an  ... more>>

NDA S NDA S Rev XXX ARAVA Tablets

GovernmentDocs 5/4/2008 | 0 (0) | 27 | 0 | 0 | English

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  ... more>>

NDA S NDA S Page PRESCRIBING INFORMATION TIMENTIN

GovernmentDocs 5/5/2008 | 0 (0) | 13 | 0 | 0 | English

NDA 50-590/S-054 NDA 50-658/S-020 Page 17 PRESCRIBING INFORMATION??TIMENTININJECTION(ticarcillin disodium and clavulanate potassium)GALAXY?? (PL 2040) Plastic Container (Product  ... more>>

NDA S NDA S January Page TAMIFLU oseltamivir

GovernmentDocs 5/4/2008 | 0 (0) | 21 | 0 | 0 | English

NDA 21-087/S-042 NDA 21-246/S-030 January 17, 2008 Page 3TAMIFLU?? (oseltamivir phosphate) CAPSULES AND FOR ORAL SUSPENSION Rx only DESCRIPTION TAMIFLU (oseltamivir phosphate) is available as  ... more>>


   
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