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http://www.fda.gov/cder/orange/appendix_a.txt
3, ACETAMINOPHEN ACETAMINOPHEN W/ CODEINE PHOSPHATE #3, ACETAMINOPHEN ACETAMINOPHEN W/ CODEINE PHOSPHATE, ACETAMINOPHEN ACETAMINOPHEN W/ CODEINE, ACETAMINOPHEN ACETAMINOPHEN, ACETAMINOPHEN (OTC) ACETAMINOPHEN, ASPIRIN AND CAFFEINE, ACETAMINOPHEN (OTC) ACETAMINOPHEN, ASPIRIN, AND CODEINE PHOSPHATE, ACETAMINOPHEN ACETAMINOPHEN, BUTALBITAL AND CAFFEINE, ACETAMINOPHEN ACETAMINOPHEN,...
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FDA Drug Approvals List September 2001
- Drug Approvals for September 2001 Definitions and Notes Original New Drug Applications Original Application #: 021279 Approval Date: 25-SEP-01 Trade Name: FORADIL Chemical Type: 3 Therapeutic Potential: S Dosage Form: POWDER, FOR INHALATION Applicant: NOVARTIS PHARMACEUTICALS CORP Active Ingredient(s): FORMOTEROL FUMARATE OTC/RX Status: RX Indication(s): For the long-term, twice...
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Prescription and OTC Drug Product List 3/1999
Prescription and Over-the-Counter Drug Product List - 19th Edition Cumulative Supplement Number 3: March 1999 [ Prescription - OTC ] ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE CALCIUM CHLORIDE; DEXTROSE; GLUTATHIONE DISULFIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CAPSULE; ORAL CHLORIDE; SODIUM PHOSPHATE...
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FDA Drug Approvals List- April 1999
Original Application #: 050760 Approval Date: 15-APR-99 Trade Name: AMOXIL Chemical Type: 3 Therapeutic Potential: S Dosage Form: SUSPENSION Applicant: SMITHKLINE BEECHAM PHARMACEUTICALS Active Ingredient(s): AMOXICILLIN OTC/RX Status: RX Indication(s):For the use of Amoxil for oral suspension 200mg/5mL and 400mg/5mL in divided doses q12h Original Application #: 020924 Approval Date:...
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FDA Drug Approvals List May 2000
Dosage Form: INJECTABLE Applicant: ASTRAZENECA UK LTD Active Ingredient(s): MEROPENEM OTC/RX Status: RX Application #: 020073 Labeling Supplement#: 010 To Original New Drug Application Approval Date: 22-MAY-00 Trade Name: ROMAZICON Dosage Form: INJECTABLE Applicant: HLR TECHNOLOGY Active Ingredient(s): FLUMAZENIL OTC/RX Status: RX Application #: 020760 Labeling Supplement#: 006 To...
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FDA Drug Approvals List September 2000
PEDIATRIC Dosage Form: INJECTABLE Applicant: ASTRAZENECA LP Active Ingredient(s): ASCORBIC ACID; VITAMIN A; ERGOCALCIFEROL; THIAMINE HYDROCHLORIDE; RIBOFLAVIN PHOSPHATE SODIUM; PYRIDOXINE HYDROCHLORIDE; DEXPANTHENOL; VITAMIN E; BIOTIN; FOLIC ACID; CYANOCOBALAMIN; PHYTONADIONE; NIACINAMIDE OTC/RX Status: RX Application #: 050679 Labeling Supplement#: 013 To Original New Drug...
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http://www.fda.gov/cder/ogd/rld/20758s18.PDF page 5
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http://www.fda.gov/cder/ogd/rld/20758s18.PDF page 4
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http://www.fda.gov/cder/ogd/rld/20758s18.PDF page 3
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http://www.fda.gov/cder/ogd/rld/20758s18.PDF page 2
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http://www.fda.gov/cder/ogd/rld/20758s18.PDF page 1
duplicates:
http://www.fda.gov/cder/ogd/rld/20757s17.PDF
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http://www.fda.gov/cder/ogd/rld/20758S16.pdf
Irbesartan- Hydrochlorothiazide The antihypertensive effects of AVALIDE (irbesartan- hydrochlorothiazide) Tablets were examined in 4 placebo- controlled studies of 8TH 12 weeks in patients with mild- moderate hypertension
In these double- blind controlled clinical trials, the following adverse experiences reported with AVALIDE occurred in ³1% of...
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http://www.fda.gov/cder/ogd/rld/20758S16.pdf page 5
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http://www.fda.gov/cder/ogd/rld/20758S16.pdf page 4
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http://www.fda.gov/cder/ogd/rld/20758S16.pdf page 3
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http://www.fda.gov/cder/ogd/rld/20758S16.pdf page 2
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http://www.fda.gov/cder/ogd/rld/20757S15.pdf
Norvitch: Please refer to your supplemental new drug applications dated February 23, 2000, submitted under section 505( b) of the Federal Food, Drug, and Cosmetic Act for Avapro (irbesartan) Tablets, 75, 150, 300 mg and Avalide (irbesartanlhydrochlorothiazide) Tablets, 75/ 12.5, 150/ 12.5, 300/ 12.5 mg
Following oral or intravenous administration of 14 C- labeled ...
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Angiotensin II receptor blockers (ARBs) - [Medication] - Quest Diagnostics Patient Health Library
Topic Contents - Examples - How It Works - Why It Is Used - How Well It Works - Side Effects - What To Think About - References Angiotensin II receptor blockers (ARBs) - [Medication] - Quest Diagnostics Patient Health Library Angiotensin II receptor blockers (ARBs) - [Medication] - Quest Diagnostics Patient Health Library Heart and circulation, Heart problems, Urinary system, AI,...
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http://www.novartis.com/downloads_new/investors/Lombard_Odier_presentation_for_print.pdf
Lombard Odier Conference 5 May, 2004 Raymund Breu CFO, Novartis AG The following information contains certain "Forward- looking Statements" relating to the Company's business, which can be identified by the use of forward- looking terminology such as "will" or "expect", or by discussions of strategy, plans, intentions or potential outcomes.
Should one or more of these risks or...
duplicates:
http://www.novartis.com/downloads_new/investors/Lombard_Odier_presentation_for_print.pdf
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http://www.novartis.com/downloads_new/investors/Lombard_Odier_presentation_for_print.pdf page 13
duplicates:
http://www.novartis.com/downloads_new/investors/Lombard_Odier_presentation_for_print.pdf
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Drug Approvals - A
NDA 21-184/S-002 9/30/02 10/2/02 10/1/02 1/15/04 Avalide (irbesartan/hydrochlorothiazide) Tablets,72/12.5, 150/12.5, & 300/12.5 mg, Rx Bristol-Myers Squibb NDA 20-758/S16 5/9/00 - - 6/6/01 Avandamet- (rosiglitazone maleate/metformin HCl) Tablets, Rx SB Pharmco Puerto Rico, Inc
NDA 20-757/S21 9/17/02 9/20/02 9/17/02 11/22/02 Avapro (irbesartan) Tablets, 75, 150, & 300...
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Reference Listed Drug Labeling Approved in September 2000
- Product Established Name NDA/Supp # Sept 1 ARMIDEX anastrozole tablets 20-541/S-006 - - - - Sept 6 MYLERAN busulfan tablets 09-386/S-018 - HEPARIN heparin sodium injection 17-007/S-038 - SERENTIL mesoridazine besylate tablet 16-774/S-072 - SERENTIL mesoridazine besylate oral solution 16-775/S-040 - SERENTIL mesoridazine besylate injection 16-997/S-040 - - - - Sept 7 EXCEDRIN...
author: John Grace
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Reference Listed Drug Labeling Approved in September 2001
Sep 4 PROGRAF letter label tacrolimus capsules tacrolimus injection S- 013 S- 010 50-708 50-709 THALOMID letter label thalidomide capsules S-014 20-785 VERSED letter ---- midazolam HCl injection S-038 18-654 Sep 5 ANDROGEL letter label testosterone gel S-003 21-015 GLUCOTROL XL letter ---- glipizide extended-release tablets S-006 20-329 Sep 6 LUVOX letter label fluvoxamine maleate...
author: USERNAME
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Reference Listed Drug Labeling Approved in May 2000
Tradename Active Ingredient Dosage Form NDA # Supp# May ACCUTANE isotretinoin capsule 18-662 S-038 1 ACCUTANE isotretinoin capsule 18-662 S-039 1 ACCUTANE isotretinoin capsule 18-662 S-040 1 ZOMIG zolmitriptan tablet 20-768 S-003 1 BUTISOL butabarbital Na tablet 00-793 S-020 2 HALDOL haloperidol tablet 15-921 S-075 2 HALDOL haloperidol lactate oral solution 15-922 S-065 2 HALDOL...
author: USERNAME
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nda 20-758/s-013
DESCRIPTION AVALIDE ® * (irb sartan- hydrochlorothiazid ) Tabl ts is a combination of an angiot nsin II r c tor antagonist ( AT 1 subty ), irb sartan, and a thiazid tic, hydrochlorothiazid HCTZ)
(S Feta /Neonata Morbidity and Morta ity.) AVALIDE ® (irbesartan- hydroch orothiazide) Table s *R gist r d trad mark of Sanofi- Synth labo, Inc
Irb sartan-...
subject: approved labeling
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