|
|
|
|
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/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,...
|
|
|
EFFICACY SUPPLEMENTS APPROVED IN CALENDAR YEAR 2003
*Supplement Type Description for SE1 - SE7 N (Chemical Type 6) SE1 SE2 SE3 SE4 SE5 SE6 SE7 NDA Type 6 - New Indication New or modified indication New dosage regimen New route of administration Comparative efficacy claim Patient population altered Change the marketing status from prescription to over the counter use Complete the traditional approval of a product originally approved...
|
|
|
FDA Drug Approvals List July 2001
PERRIGO COMPANY Active Ingredient(s):ACETAMINOPHEN; ASPIRIN;CAFFEINE OTC/RX Status: RX Labeling Supplements to Original New Drug Applications Application #: 019906 Labeling Supplement#: 009 To Original New Drug Application Approval Date: 31-JUL-01 Trade Name: ANAFRANIL Dosage Form: CAPSULE Applicant: NOVARTIS PHARMACEUTICALS CORP Active Ingredient(s): CLOMIPRAMINE HYDROCHLORIDE...
|
|
|
FDA Drug Approvals List January 2002
Active Ingredient(s):LISINOPRIL OTC/RX Status: RX Original Abbreviated Application #: 076119 Tentative Approval Date: 15-JAN-02 Trade Name: MIRTAZAPINE Dosage Form: TABLET Applicant: TEVA PHARMACEUTICALS USA INC Active Ingredient(s): MIRTAZAPINE OTC/RX Status: RX Original Abbreviated Application #: 075977 Tentative Approval Date: 15-JAN-02 Trade Name: TRAMADOL HYDROCHLORIDE...
|
|
|
021073A_Actos.htm Actos (Pioglitazone Hydrochloride) Tablets
Food and Drug Administration • Center for Drug Evaluation and Research Approval Package [http://internet-dev/cder/templates/2ndrow-component.htm] [http://internet-dev/cder/templates/sidebar-component.htm] Actos (Pioglitazone Hydrochloride) Tablets Company:- Takeda Armerica Research & Dev
Application No.:- 021073 Approval Date:-7/15/99 - Approval Letter(s) (995 KB)...
author: Paul Stauffer
|
|
|
Efficacy Supplements Approved in Calendar Year 2002 (SE1-SE7 AND SE8s
----------- This list is updated quarterly.- Updated through 12/31/02 -------------------- Top of Page ---------- EFFICACY SUPPLEMENTS APPROVED IN CALENDAR YEAR 2002 (SE8)* Top of Page GENERIC NAME APPLICANT NDA NUMBER SUPP TYPE SUPP NUMBER RECEIPT DATE APPROVAL DATE PRIORITY REVIEW TOTAL APPROVAL TIME (MONTHS) ABACAVIR SULFATE, LAMIVUDINE, AND ZIDOVUDINE GLAXOSMITHKLINE 21-205 SE8...
author: Darlene Norris
|
|
|
ranbaxy
- - - - - - You are here :- Home - Products - - Dosage Forms - INDIA DOSAGE FORMS LIST- (Updated Jan 2002) Anti-infectives G.I. & Nutritionals CVS & Diabetes CNS NSAID & related Anti-allergants ...
|
|
|
ranbaxy
- - - - - You are here :- Home - International Operations - - Global API- Products PRODUCTS Anti-Infectives Semi-synthetic Penicillins Amoxycillin Trihydrate Ampicillin Trihydrate Cloxacillin Sodium ...
|
|
|
ranbaxy
- - - - - - You are here : Home - Products - - APIs GLOBAL API Active Pharmaceutical Ingredients(API) Ranbaxy's Global API business is a combination of commodity and technology products operating in regulated ...
|
|
|
21073LBL.PDF page 26
author: Unknown
|
|
|
21073LBL.PDF page 25
author: Unknown
|
|
|
21073LBL.PDF page 24
author: Unknown
|
|
|
21073LBL.PDF page 23
author: Unknown
|
|
|
21073LBL.PDF page 22
author: Unknown
|
|
|
21073LBL.PDF page 21
author: Unknown
|
|
|
21073LBL.PDF page 20
author: Unknown
|
|
|
21073LBL.PDF page 19
author: Unknown
|
|
|
21073LBL.PDF page 18
author: Unknown
|
|
|
21073LBL.PDF page 17
author: Unknown
|
|
|
21073LBL.PDF page 16
author: Unknown
|
|
|
21073LBL.PDF page 15
author: Unknown
|
|
|
21073LBL.PDF page 14
author: Unknown
|
|
|
21073LBL.PDF page 13
author: Unknown
|
|
|
21073LBL.PDF page 12
author: Unknown
|
