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, SECRETIN...
20692S1,2_Serevent.htm Food and Drug Administration • Center for Drug Evaluation and Research Approval Package Search Serevent (Salmeterol Xinafoate Inhalation) Diskus Company:- Glaxo Wellcome Inc
author: Paul Stauffer
http://www.fda.gov/cder/ogd/rld/RLD_LABELING_APPROVED_DEC_1998.HTML Reference Listed Drug Labeling Approved in December 1998 Some of the product names below contain links to the approved labeling or the supplemental approval letter describing the specific changes.- Click on the product name to view the approved labeling changes in Adobe Acrobat format
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...
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:...
FDA Drug Approvals List March 2002 - Drug Approvals for March 2002 Definitions and Notes Original New Drug Applications Original Application #: 020855 Approval Date: 21-MAR-02 Trade Name: MESNA Chemical Type: 3 Therapeutic Potential: S Dosage Form: TABLET Applicant: ASTA MEDICA AG Active Ingredient(s): MESNA OTC/RX Status: RX Indication(s): For the use as a prophylactic agent in reducing the incidence of ifosfamide...
DOCUMENT INFORMATION PAGE 1 PRESCRIBING INFORMATION 1 ADVAIR DISKUS ® 100/ 50 2 (fluticasone propionate 100 mcg and salmeterol* 50 mcg inhalation powder) 3 4 ADVAIR DISKUS ® 250/ 50 5 (fluticasone propionate 250 mcg and salmeterol* 50 mcg inhalation powder) 6 7 ADVAIR DISKUS ® 500/ 50 8 (fluticasone propionate 500 mcg and salmeterol* 50 mcg inhalation powder) 9 10 *As ...
author: 599
FDA Drug Approvals List February 2000 - Drug Approvals for February 2000 Definitions and Notes Original New Drug Applications Original Application #: 021015 Approval Date: 28-FEB-00 Trade Name: ANDROGEL Chemical Type: 3 Therapeutic Potential: S Dosage Form: GEL Applicant: UNIMED PHARMACEUTICALS INC Active Ingredient(s): TESTOSTERONE OTC/RX Status: RX Indication(s): For replacement therapy in males for conditions...
Efficacy Supplements Approved in Calendar Year 2002 (SE1-SE7 AND SE8s EFFICACY SUPPLEMENTS APPROVED IN CALENDAR YEAR 2002 (SE1 -SE7)* and EFFICACY SUPPLEMENTS APPROVED IN CALENDAR YEAR 2002 (SE8)* - GENERIC NAME APPLICANT NDA NUMBER SUPP TYPE SUPP NUMBER RECEIPT DATE APPROVAL DATE PRIORITY REVIEW- TOTAL APPROVAL TIME (MONTHS) INDICATION/DESCRIPTION ANASTROZOLE ASTRAZENECA 20-541 SE1 010 5-Mar-02 5-Sep-02 Y 6.0 Provides for the use of ARIMIDEX ...
author: Darlene Norris
01-287 PhRMA NewMed WomenforPDF page 17
author: RL
01-181 PhRMA NewMed Hispan 5/13 page 18
author: RL
01-181 PhRMA NewMed Hispan 5/13 page 17
author: RL
02-137 PhRMA NewMed OlderAm6/24 page 16
author: RL
FDA Drug Approvals List- May 1998 In this setting, INTEGRILIN has been shown to decrease the rate of a combined endpoint of death, new myocardial infarction, or need for urgent intervention Original Application #: 020774 Approval Date: 15-MAY-98 Trade Name: PERIO CHIP Chemical Type: 3 Therapeutic Potential: S Dosage Form: CHIP Applicant: PERIO PRODUCTS LTD Active Ingredient(s): CHLORHEXIDINE GLUCONATE OTC/RX Status:...
FDA Drug Approvals List- February 1998 Drug Approvals for February 1998 Definitions and Notes February 1998 Original New Drug Applications Original Application #: 050750 Approval Date: 24-FEB-98 Trade Name: ZOSYN Chemical Type: 3 Therapeutic Potential: S Dosage Form: INJECTABLE Applicant: LEDERLE PIPERACILLIN INC DIV AMERICAN CYANAMID CO Active Ingredient(s): PIPERACILLIN SODIUM; TAZOBACTAM SODIUM OTC/RX Status: RX...
FDA Drug Approvals List- December 1998 Drug Approvals for December 1998 Definitions and Notes December 1998 Original New Drug Applications Original Application #: 020998 Approval Date: 31-DEC-98 Trade Name: CELEBREX Chemical Type: 1 Therapeutic Potential: P Dosage Form: CAPSULE Applicant: GD SEARLE AND CO Active Ingredient(s): CELECOXIB OTC/RX Status: RX Indication(s):For the signs and symptoms of osteoarthritis and...
FDA Drug Approvals List- August 1998 Drug Approvals for September 1998 Definitions and Notes September 1998 Original New Drug Applications Original Application #: 050744 Approval Date: 30-SEP-98 Trade Name: PERIOSTAT Chemical Type: 3 Therapeutic Potential: S Dosage Form: CAPSULE Applicant: COLLAGENEX INC Active Ingredient(s): DOXYCYCLINE HYCLATE OTC/RX Status: RX Indication(s): To promote attachment level gain and to...
FDA DRUG AND DEVICE PRODUCT APPROVALS 74-776 TIMOLOL MALEATE BAUSCH AND LOMB TIMOLOL MALEATE 26-JUL-96 (SOLUTION/DROPS) TAMPA, FL 0.5% 33637 (BETA ADRENERGIC BLOCKER) 74-778 TIMOLOL MALEATE BAUSCH AND LOMB TIMOLOL MALEATE 26-JUL-96 (SOLUTION/DROPS) TAMPA, FL 0.25% 33637 (BETA ADRENERGIC BLOCKER) 74-465 TIMOLOL MALEATE ADV REMEDIES TIMOLOL MALEATE 30-JUL-96 (SOLUTION/DROPS) SOMERSET, NJ 0.25% 08873 (BETA ADRENERGIC...
July Drug Approvals Drug Approvals for July 1996 Definitions and Notes Original New Drug Application Original Application #: 020538 Approval Date: 31-JUL-96 Trade Name: ESTRADIOL Chemical Type: Already marketed drug product but a new manufacturer Therapeutic Potential: Standard review drug Dosage Form: FILM, EXTENDED RELEASE Applicant: MENOREST MANFACTURING INC Active Ingredient(s): ESTRADIOL OTC/RX...
Drug Approvals for November 1997 Drug Approvals for November 1997 Definitions and Notes November 1997 Original New Drug Applications Original Application #: 020652 Approval Date: 26-NOV-97 Trade Name: TESLASCAN Chemical Type: 1 Therapeutic Potential: S Dosage Form: INJECTABLE Applicant: NYCOMED INC Active Ingredient(s): MANGAFODIPIR TRISODIUM OTC/RX Status: RX Indication(s): As an adjunct to MRI to enhance the T1...
Drug Approvals for September 1997 The development of multiple follicles in the ovulatory patient participating in an Assisted Reproductive Technology (ART) program Original Application #: 020857 Approval Date: 26-SEP-97 Trade Name: COMBIVIR Chemical Type: 4 Therapeutic Potential: P Dosage Form: TABLET Applicant: GLAXO WELLCOME INC Active Ingredient(s): LAMIVUDINE; ZIDOVUDINE OTC/RX Status: RX Indication(s): Treatment...
http://www.fda.gov/cder/da/ddpa94.wpd DEPARTMENT OF HEALTH AND HUMAN SERVICES, PUBLIC HEALTH SERVICE NDA NUMBER APPROVAL DATE (CLASSIFICATION)TRADE NAME (DOSAGE FORM)APPLICANTACTIVE INGREDIENT(S) STRENGTH(S) CLASSIFICATION(S) ***ORIGINAL AND SUPPLEMENTAL NDAs*** FOR NEW DRUG PRODUCTS 20 236 SEREVENT GLAXO SALMETEROL XINAFOATE 04 FEB 94 (AEROSOL, METERED) RES TRIANGLE PK, NC EQ 0.021MG BASE/INH (1 P)...
1997 New Drug Application (NDA) 018381/S027 4/16/1997 11/ 20/1997 Requip/Ropinirole Hydrochloride Approval/Approvable Letter [502 KB] Medical Review(s) Part 1 [4.8 MB], Part 2 [3.9 MB], Part 3 [4.4 MB] Chemistry Review(s)/EA(Fonsi) [4.2 MB] Pharmacology Review(s) Part 1 [4.4 MB], Part 2 [3.2 MB] Statistical Review(s) [3.7 MB] Clinical Pharmacology Biopharmaceutics Review(s) [1.4 MB] Administrative Documents [3.2 MB...
EFFICACY SUPPLEMENTS APPROVED IN CALENDAR YEAR 2003 FDA Home Page | CDER Home Page | CDER Site Info | Contact CDER | What's New @ CDER - Search - - EFFICACY SUPPLEMENTS APPROVED IN CALENDAR YEAR 2003 (SE1 -SE7)* and EFFICACY SUPPLEMENTS APPROVED IN CALENDAR YEAR 2003 (SE8)* - GENERIC NAME APPLICANT NDA NUMBER SUPP TYPE SUPP NUMBER RECEIPT DATE APPROVAL DATE PRIORITY REVIEW TOTAL APPROVAL TIME (MONTHS) INDICATION/DESCRIPTION FLUOXETINE...
21077_Advair Diskus_ Food and Drug Administration • Center for Drug Evaluation and Research Title Search ADVAIR DISKUS (Fluticasone Propionate and Salmeterol Xinafoate) Inhalation Powder Company:--Glaxo Wellcome Inc
author: USERNAME
