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Drug Approvals - M
Product Name Company Application # Approval Date Letter Posted Label Posted Review Posted M-Zole 3 Combination Pack [Miconazole Nitrate Vaginal Suppositories USP, 200 mg and Miconazole Cream USP, 2% (Combination package)], OTC, Alpharma ANDA 74-926 4/16/99 4/28/99 - 1/14/02 Macrobid (nitrofurantoin monohydrate/macrocrystals) Capsules,- Procter & Gamble NDA 20-064/S-014 10/31/03 11/5...
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http://www.fda.gov/cder/orange/appendix_a.txt
RTU IN PLASTIC CONTAINER, METRONIDAZOLE FLAGYL I.V., METRONIDAZOLE HYDROCHLORIDE FLAGYL, METRONIDAZOLE FLAREX, FLUOROMETHOLONE ACETATE FLAVORED COLESTID, COLESTIPOL HYDROCHLORIDE FLAVOXATE HCL, FLAVOXATE HYDROCHLORIDE FLAXEDIL, GALLAMINE TRIETHIODIDE FLECAINIDE ACETATE, FLECAINIDE ACETATE FLEXERIL, CYCLOBENZAPRINE HYDROCHLORIDE FLEXICORT, HYDROCORTISONE FLOLAN, EPOPROSTENOL SODIUM...
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ANDA Approvals - September 2003
- FDA Home Page | CDER Home Page | CDER Site Info | Contact CDER | What's New @ CDER - Search - -Approvals - September 2003 - ANDA Number Generic Drug Name Applicant Approval Date 1 76-220 OFLOXACIN TABLETS 200 MG, 300 MG, AND 400 MG - RANBAXY LABORATORIES LIMITED 9/2/2003- 2 76-093 OFLOXACIN TABLETS 200 MG, 300 MG, AND 400 MG - PAR PHARMACEUTICAL, INC
9/16/2003- 21 76-409...
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FDA Drug Approvals List May 2001
Pylori eradication to reduce the risk of duodenal ulcer recurrence, maintenance of healed duodenal ulcers, short-term treatment of active benign gastric ulcer, short-term treatment of symptomatic gastroesophageal reflux disease (GERD), short-term treatment of erosive esophagitis, maintenance of healing of erosive esophagitis, and pathological hypersecretory conditions including...
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FDA Drug Approvals List February 2001
Approvable Original New Drug Applications - Original Abbreviated New Drug Applications Original Abbreviated Application # 075402 Approval Date: 28-FEB-01 Trade Name: METAPROTERENOL SULFATE Dosage Form: SOLUTION Applicant: NOVEX PHARMA Active Ingredient(s): METAPROTERENOL SULFATE OTC/RX Status: RX Original Abbreviated Application # 075403 Approval Date: 28-FEB-01 Trade Name:...
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C:\Documents and Settings\crisostomon\My Documents\NDAs\NDA 17354\\ SLRs\apSLR11.9.01.doc page 1
author: Nenita Crisostomo
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http://www.fda.gov/cder/foi/label/2001/21276lbl.pdf page 55
duplicates:
http://www.fda.gov/cder/foi/label/2001/20130s7lbl.pdf
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http://www.novavax.com/images/nestabs_RX_CBF_FA.pdf
Nestabs@ RX Prenatal Multi- vitamin/ Mineral Tablets Description Nestabs@ RX is a light blue film- coated tablet with "NRX" debossed on one side and scored on the opposite side
Contraindications This product is contraindicated in patients with a known hypersensitivity to any of the ingredients Warnings Folic acid alone is improper therapy in the treatment of pernicious anemia and...
author: SSpears [ NOXNT ]
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http://www.novavax.com/images/nestabs_RX_CBF_FA.pdf page 5
author: SSpears [ NOXNT ]
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http://www.fda.gov/cder/foi/appletter/2001/75647ltr.pdf
ANDA 75- 647 February 5, 2001 Watson Laboratories, Inc
Attention: Ernest Lengle 311 Bonnie Circle Corona, CA 92880 Dear Sir: This is in reference to your abbreviated new drug application dated June 11, 1999, submitted pursuant to Section 505( j) of the Federal Food, Drug, and Cosmetic Act (Act), for MicrogestinO Fe 1/ 20 Tablets (Norethindrone Acetate and Ethinyl Estradiol Tablets...
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http://www.fda.gov/cder/foi/appletter/2001/75647ltr.pdf page 1
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http://www.fda.gov/cder/foi/appletter/2001/75548ltr.pdf
ANDA 75- 548 February 5, 2001 Watson Laboratories, Inc
311 Bonnie Circle Corona, CA 92880 Dear Sir: This is in reference to your abbreviated new drug application dated December 30, 1998, submitted pursuant to Section 505( j) of the Federal Food, Drug, and Cosmetic Act (Act), for MicrogestinO Fe 1.5/ 30 Tablets (Norethindrone Acetate and Ethinyl Estradiol Tablets USP, 1.5 mg and 0...
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http://www.fda.gov/cder/foi/appletter/2001/75548ltr.pdf page 1
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Re: calcium propionate
Nutrition Supplements : : : Calcium Citrate : : : Calcium Gluconate : : : Calcium Lactate : : : Creatin monohydrate : : : ss-Carotene : : : Copper Gluconate : : : DL-Methionine : : : Ferrous Fumarate : : : Ferrous Gluconate : : : Ferrous Lactate : : : Folic acid : : : Inositol : : : L-Aspartic acid : : : L-Carnitine : : : L-Cysteine HCL(Monohydrate & Anhydrous...
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Re: calcium propionate
Nutrition Supplements : : : Calcium Citrate : : : Calcium Gluconate : : : Calcium Lactate : : : Creatin monohydrate : : : ss-Carotene : : : Copper Gluconate : : : DL-Methionine : : : Ferrous Fumarate : : : Ferrous Gluconate : : : Ferrous Lactate : : : Folic acid : : : Inositol : : : L-Aspartic acid : : : L-Carnitine : : : L-Cysteine HCL(Monohydrate & Anhydrous...
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Re: Vanillin Powder made in China
Nutrition Supplements : : : Calcium Citrate : : : Calcium Gluconate : : : Calcium Lactate : : : Creatin monohydrate : : : ss-Carotene : : : Copper Gluconate : : : DL-Methionine : : : Ferrous Fumarate : : : Ferrous Gluconate : : : Ferrous Lactate : : : Folic acid : : : Inositol : : : L-Aspartic acid : : : L-Carnitine : : : L-Cysteine HCL(Monohydrate & Anhydrous...
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Re: Vanillin Powder made in China
Nutrition Supplements : : Calcium Citrate : : Calcium Gluconate : : Calcium Lactate : : Creatin monohydrate : : ss-Carotene : : Copper Gluconate : : DL-Methionine : : Ferrous Fumarate : : Ferrous Gluconate : : Ferrous Lactate : : Folic acid : : Inositol : : L-Aspartic acid : : L-Carnitine : : L-Cysteine HCL(Monohydrate & Anhydrous) : : L-Cystine : : L-Glutamic...
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DDPA June 1995
74-423 CAPTOPRIL MOVA CAPTOPRIL 07-JUN-95 (TABLET) CAGUAS, PR 12.5MG 00725 25MG 50MG 100MG (ANGIOTENSIN CONVERTING ENZYME INHIBITOR) ***LABELING SUPPLEMENTS TO ORIGINAL NDAs*** 17-911 CLINORIL MERCK SULINDAC 01-JUN-95 (TABLET) WEST POINT, PA 150MG 19486 200MG (LABELING REVISION -- PRECAUTIONS; ADVERSE REACTIONS) 16-744* NORIDAY 1+50-FE SYNTEX FERROUS FUMARATE 02-JUN-95 ...
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DDPA May 1995
***LABELING SUPPLEMENTS TO ORIGINAL NDAs*** 19-915 MONOPRIL BRISTOL MYERS SQUIBB FOSINOPRIL SODIUM 02-MAY-95 (TABLET) PRINCETON, NJ 10MG 08543 20MG 40MG (LABELING REVISION -- CLINICAL PHARMACOLOGY; INDICATIONS AND USAGE; ADVERSE REACTIONS; DOSAGE AND ADMINISTRATION) 18-206* LO/OVRAL-28 WYETH AYERST LABS ETHINYL ESTRADIOL 03-MAY-95 AND FERROUS FUMARATE PHILADELPHIA, PA 0...
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DDPA March 1996
74-488 RANITIDINE HCL GRANUTEC RANITIDINE HYDROCHLORIDE 05-MAR-96 (TABLET) WILSON, NC EQ 150MG BASE 27896 EQ 300MG BASE (HISTAMINE H-2 RECEPTOR ANTAGONIST) ***LABELING SUPPLEMENTS TO ORIGINAL NDAs*** 04-570 HEPARIN SODIUM UPJOHN HEPARIN SODIUM 04-MAR-96 (INJECTABLE) KALAMAZOO, MI 1,000 UNITS/ML 49001 5,000 UNITS/ML 10,000 UNITS/ML (LABELING REVISION -- WARNINGS; PRECAUTIONS; ADVERSE...
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OTC Drug Review Ingredient Status
12 INGREDIENT NAME ADDITIONS INGREDIENT NAME ADDITIONS TO THE AUGUST 1985 AND NOVEMBER 1986 EDITIONS: Dexbrompheniramine Maleate Dexchlorpheniramine Maleate Ipecac Tincture Jojoba Oil Nucleic Acids Polycarbophil, Calcium INGREDIENT NAME ADDITIONS TO THE AUGUST 1985 AND NOVEMBER 1986 EDITIONS (Cont'd): Polysorbate 20 Polysorbate 60 Sulfanilamide Sulfur (Paraffinic Hydrocarbons)...
author: Paul Stauffer
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OTC Drug Review Ingredient Status page 13
author: Paul Stauffer
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Product:
SCO1254, 2SCG18.01, purB, 2SCG1.29 Class Start/End Length 3.7.1 1325285/1326727 480 putative adenylosuccino lyase (fragment) adenylosuccino lyase (fragment) Description: 2SCG18.01, purB, probable adenylosuccino lyase (fragment), len: >362 aa; highly similar to TR:Q9RHX3 (EMBL:AB00316) Corynebacterium ammoniagenes adenylosuccino lyase PurB, 479 aa; fasta scores: opt: 1625 z-score:...
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Product:
SCO5107, SCBAC31E11.02c, shdA2 Class Start/End Length 3.5.8 5548604/5550565 653 putative succinate dehydrogenase flavoprotein subunit Description: SCBAC31E11.03c, shdA2, probable succinate dehydrogenase flavoprotein subunit, len: 653 aa; highly similar to TR:AAK44480 (EMBL:AE006934) Mycobacterium tuberculosis CDC1551 FAD flavoprotein oxidase, putative MT0262, 646 aa; fasta scores:...
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Product:
SCO5044, fumB, SCK7.17c Class Start/End Length 3.5.8 5483742/5485418 558 fumarate hydratase class I Description: SCK7.17c, fumB, fumarate hydratase class I, len: 558 aa; similar to SW:FUMB_ECOLI (EMBL:M27058) Escherichia coli fumarate hydratase class I, anaerobic (EC 4.2.1.2) FumB, 548 aa; fasta scores: opt: 2386 z-score: 2782.7 E(): 0; 64.9% identity in 539 aa overlap.
Contains...
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