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NDA S Page FDA Approved Patient Labeling HalfLytely detailed view
NDA S Page FDA Approved Patient Labeling HalfLytely detailed view
From: FDADocs | Date: 5/9/2008 | Rated: 0 (0) | Views: 56
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NDA 21-551/S-006 Page 9 17.4 FDA-Approved Patient Labeling • HalfLytely and Bisacodyl Tablets Bowel Prep Kit produces a watery stool which cleanses ...  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
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NDA S Page Patient s Instructions For Use detailed view
NDA S Page Patient s Instructions For Use detailed view
From: FDADocs | Date: 5/9/2008 | Rated: 0 (0) | Views: 11
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NDA 20-441/S-020 Page 21 33021-00 Patient’s Instructions For Use For Oral Inhalation Only. Please read this leaflet carefully before you start to ...  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
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NDA S Page PATIENT INFORMATION ABOUT FORTAMET metformin detailed view
NDA S Page PATIENT INFORMATION ABOUT FORTAMET metformin detailed view
From: FDADocs | Date: 5/9/2008 | Rated: 0 (0) | Views: 36
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NDA 21-574/S-006 Page 24 PATIENT INFORMATION ABOUT FORTAMET® (metformin hydrochloride) ExtendedRelease Tablets Rx only Q1. Why do I need to take ...  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
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NDA S NDA S Approved Labeling Text dated 2001
NDA S NDA S Approved Labeling Text dated 2001
From: FDADocs | Date: 5/9/2008 | Rated: 0 (0) | Views: 24
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NDA 20-505/S-002 NDA 20-844/S-010 Approved Labeling Text dated 08/28/01 Page 6 WARNINGS Acute myopia and secondary angle closure glaucoma A syndrome c ...  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
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NDA AttachmentRx only SERZONE nefazodone hydrochloride Tablets Before 2002
NDA AttachmentRx only SERZONE nefazodone hydrochloride Tablets Before 2002
From: FDADocs | Date: 5/9/2008 | Rated: 0 (0) | Views: 13
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NDA 20-152 AttachmentRx only SERZONE® (nefazodone hydrochloride) Tablets Before prescribing SERZONE, the physician should be thoroughly familiar 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
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NDA S NDA S Page MACUGEN pegaptanib sodium 2006
NDA S NDA S Page MACUGEN pegaptanib sodium 2006
From: FDADocs | Date: 5/9/2008 | Rated: 0 (0) | Views: 28
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NDA 21-756/S-006 NDA 21-756/S-007 Page 3 MACUGEN® (pegaptanib sodium injection) DESCRIPTION MACUGEN® (pegaptanib sodium injection) is a sterile, aque ...  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
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NDA S Page DRAFT PACKAGE INSERT Package Insert detailed view
NDA S Page DRAFT PACKAGE INSERT Package Insert detailed view
From: FDADocs | Date: 5/9/2008 | Rated: 0 (0) | Views: 23
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NDA 16-733/S-049 Page 3 DRAFT PACKAGE INSERT Y36-002-475 Package Insert PIC™ (Plastic Irrigation Container) ________________________________________ ...  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
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Memorandum to File To NDA file From S
Memorandum to File To NDA file From S
From: FDADocs | Date: 5/9/2008 | Rated: 0 (0) | Views: 16
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Memorandum to File To: NDA 21-210 file From: S. Markofsky (Acting Team Leader) Subject: Storage Statement for Jerome Sevens Pharmaceutical's ...  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 >
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NDA Jerome Stevens Pharmaceuticals Inc Attention Mr Ronald
NDA Jerome Stevens Pharmaceuticals Inc Attention Mr Ronald
From: FDADocs | Date: 5/9/2008 | Rated: 0 (0) | Views: 21
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NDA 21-210 Jerome Stevens Pharmaceuticals, Inc. Attention: Mr. Ronald J. Steinlauf Vice President Sixty DaVinci Drive Bohemia, NY 11716 Dear Mr. ...  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 >
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NDA FDA MEDICAL AND STATISTICAL ODAC REPORT Drug
NDA FDA MEDICAL AND STATISTICAL ODAC REPORT Drug
From: FDADocs | Date: 5/9/2008 | Rated: 0 (0) | Views: 143
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sNDA 20-726 FDA MEDICAL AND STATISTICAL ODAC REPORT Drug Name: Femara® Letrozole tablets Applicant: Novartis Date Submitted: July 11, 2000 Date Receiv ...  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
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Attachment Minutes of pre NDA meeting for IND
Attachment Minutes of pre NDA meeting for IND
From: FDADocs | Date: 5/9/2008 | Rated: 0 (0) | Views: 16
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Meeting Date:January9. 1997 MD: micOna2oic nitrateointmenr Time: 1000 Location:N225 Sponsor:JohnsonandJohnson : Prc-NDA Meeting Chair: ...  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
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Views: 16
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