http://www.fda.gov/cder/orange/appendix_a.txt 2, BUTABARBITAL SODIUM SARISOL, BUTABARBITAL SODIUM APPENDIX A PRODUCT NAME INDEX SATRIC, METRONIDAZOLE SCABENE, LINDANE SCANDONEST L, LEVONORDEFRIN SCANDONEST PLAIN, MEPIVACAINE HYDROCHLORIDE SCLEROSOL, TALC SCRUBTEAM SURGICAL SPONGEBRUSH, HEXACHLOROPHENE SEASONALE, ETHINYL ESTRADIOL SECOBARBITAL SODIUM, SECOBARBITAL SODIUM SECONAL SODIUM, SECOBARBITAL SODIUM SECREFLO,...
Report.PDF page 4
author: default
http://www.barrlabs.com/overview/annual/BRL_AR2001.pdf Barr Laboratories, Inc.Hydrochloride, the generic equivalent of Wyeth Ayerst Laboratories, Inc.
Paragraph IV Patent Certifications - DRUG NAME DOSAGE FORM STRENGTH RLD Acetaminophen Extended-release Tablets 650 mg Tylenol Acetaminophen/ Aspirin/ Caffeine Tablets 250 mg/250 mg/ 65 mg Excedrin (migraine) Acetaminophen and Tramadol Hydrochloride Tablets 325 mg/ 37.5 mg Ultracet Acyclovir Sodium1 Injection 50 mg/mL, 10 mL and 20 mL vials Zovirax Albuterol Sulfate Oral Syrup 2 mg(base)/ 5 mL Ventolin Albuterol...
http://www.fda.gov/cder/dmf/text/4Q2003ACTIVETYPE2TEXT.txt CHICAGO, ILL FACIL" 4537 07-Apr-82 DIPHARMA FRANCIS SPA HYDROFLUMETHIAZIDE USP 4538 07-Apr-82 RECORDATI INDUSTRIA CHIMICA E FARMACEUTICA SPA DIPHENYLHYDANTOIN SODIUM SALT 4539 17-May-82 R MASON CHEMICALS LTD SELENIUM DISULFIDE 4555 17-Mar-82 AJINOMOTO USA INC "AMINO ACIDS MANUFACTURED IN RALEIGH, NORTH CAROLINA." 4561 12-May-82 FINE CHEMICALS CORPORATION VINCRISTINE SULPHATE...
http://www.fda.gov/cder/dmf/xls/4Q2003ACTIVETYPE2EXCEL.xls URSODEOXYCHOLIC ACID MEDIMPEX INC ALPHA METHYLDOPA USP XIX BULK AS MFG BY EGIS PHARMACEUT WORKS BUDAPEST ACRAF TRAZODONE HCL ROCHE COLORADO CORPORATION BUTOCONAZOLE NITRATE GEDEON RICHTER LTD NORETHISTERONE DINAMITE DIPHARMA SPA FUROSEMIDE USP SCHERING AG ESTRADIOL-VALERATE SCHERING AG TESTOSTERONE ENANTHATE PROQUINA SA PIPERAZINE ESTRONE SULFATE MERCK AG METHYL GLUCAMINE ...
1997 Abbreviated New Drug Applications (Generic Drugs) 074946 11/19/1997 3/30/1998 Adriamycin PFS (Doxorubicin Hydrochloride) Injection ,- Adria Laboratories 63165/S3, S5, S6 7/9/1993 8/8/2002 Albuterol Inhalation Aerolsol, 90 mcg/ActuationHydrochloride [2 MB] Taro Pharmaceuticals 074694 12/13/1996 12/3/1997 Clomipramine Hydrochloride Capsules, 25, 50, & 75 mg
Quartely List of Guidance Documents at the Food and Drug Administration page 12
author: FDA
Comprehensive List of Current Guidance Documents at the Food and Drug Administration page 31
author: FDA
Drug Approvals for April 1997 Drug Approvals for April 1997 Definitions and Notes April 1997 Original New Drug Applications Original Application #: 020619 Approval Date: 17-APR-97 Trade Name: BETOPTIC PILO Chemical Type: 4 Therapeutic Potential: S Dosage Form: SUSPENSION/DROPS Applicant: ALCON LABORATORIES INC Active Ingredient(s): BETAXOLOL HYDROCHLORIDE; PILOCARPINE HYDROCHLORIDE OTC/RX Status: RX...
http://www.fda.gov/cber/gdlns/guidelst.txt Drug Advertising and Promotional Labeling DDMAC 2 Dissemination of Reprints of Certain October 8, 1996 Advertising Do Published, Original Data Funded Dissemination of Reference October 8, 1996 Do Do Texts Antifungal (topical) February 24, 1990 Biopharmaceutic Drug Information Branch (Draft) Antifungal (vaginal) February 24, 1990 Do Do Food-Effect Bioavailability and December 30, 1997...
http://www.fda.gov/cber/gdlns/qrtrgde.txt Guidance Documents Issued by the Center for Drug Evaluation and Research (CDER) ---------------------------------------------------------------------------------------------------------------- How to Obtain a Hard Grouped by Intended Copy of the Document Name of Document Date of Issuance User or Regulatory (Name and Address, Activity Phone, FAX, E-mail or Internet) ------------------...
DDPA December 1995 20-545 PROCANBID PARKE DAVIS PROCAINAMIDE HYDROCHLORIDE 14-DEC-95 (TABLET, ANN ARBOR, MI 500MG EXTENDED RELEASE) 48106 1000MG (ANTIARRHYTHMIC) 20-518 RETROVIR GLAXO WELLCOME ZIDOVUDINE 19-DEC-95 (TABLET) RES TRIANGLE PK, NC 300MG 27709 (ANTIVIRAL) 20-535 BROMFENAC SODIUM WYETH AYERST BROMFENAC SODIUM 28-DEC-95 (CAPSULE) RADNOR, PA EQ 25MG BASE 19087 EQ 50MG BASE (NONSTEROIDAL...
http://www.fda.gov/cder/da/ddpa93.wpd 20 142 CATAFLAM GEIGY DICLOFENAC POTASSIUM 03 30 93 (TABLET) SUMMIT, NJ 25MG 07901 50MG (NONSTEROIDAL ANTI-INFLAMMATORY) 73 535 PIROXICAM MUTUAL PHARM PIROXICAM 03 12 93 (CAPSULE) PHILADELPHIA, PA 10MG 19124 (NONSTEROIDAL ANTI-INFLAMMATORY) 73 536 PIROXICAM MUTUAL PHARM PIROXICAM 03 12 93 (CAPSULE) PHILADELPHIA, PA 20MG 19124 (NONSTEROIDAL ANTI-INFLAMMATORY) 73 136 TRAZODONE ...
http://www.fda.gov/cder/da/ddpa91.wpd 19 531 NUTRILI 10% MCGAW SOYBEAN OIL 02 08 91 (INJECTABLE) IRVINE, CA 10% 92713 (NUTRIENT REPLENISHER) 19 531 NUTRILI 20% MCGAW SOYBEAN OIL 02 08 91 (INJECTABLE) IRVINE, CA 20% 92713 (NUTRIENT REPLENISHER) 20-069 DIANEAL PD-2 BAXTER CALCIUM CHLORIDE 02-19-91 ELECTROLYTE ROUND LAKE, IL 514MG/100ML CONCENTRATE 60073 MAGNESIUM CHLORIDE IN PLASTIC CONTAINER 102MG/100ML (SOLUTION) SODIUM...
