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 4, ACETAMINOPHEN TYLENOL W/ CODEINE, ACETAMINOPHEN TYLENOL, ACETAMINOPHEN (OTC) TYLOX, ACETAMINOPHEN TYLOX-325, ACETAMINOPHEN TYMTRAN, CERULETIDE DIETHYLAMINE TYZINE, TETRAHYDROZOLINE HYDROCHLORIDE TZ-3, TIOCONAZOLE (OTC) ** U ** U-CORT, HYDROCORTISONE ACETATE U-GENCIN, GENTAMICIN SULFATE UCEPHAN, SODIUM BENZOATE ULO, CHLOPHEDIANOL HYDROCHLORIDE ULTANE, SEVOFLURANE ULTIVA...
NDAs Approved under Subpart H NDAs Approved under Subpart H NDA # Trade Name Generic -Name Clock Date Approval Date AP Time Approval Basis Indication - - - - - - - - 20199 Hivid Zalcitabine 31-Oct-91 19-Jun-92 7.6 S Combination therapy with zidovudine in advanced HIV infection - - - - - - - - 50698 Biaxin Clarithromycin- 2-Nov-92 23-Dec-93 13.7 S Treatment of disseminated mycobacterial infections due to...
author: Darlene Norris
Efficacy Supplements Approved in Calendar Year 2002 (SE1-SE7 AND SE8s DEXRAZOXANE FOR INJECTION PHARMACIA AND UPJOHN 20-212 SE7 006 31-Dec-01 31-Oct-02 - 10.0 Provides support for conversion of ZINECARD for Injection (dexrazoxane for injection) from accelerated to regular approval
author: Darlene Norris
DDPA June 1995 DEPARTMENT OF HEALTH AND HUMAN SERVICES, PUBLIC HEALTH SERVICE NDA NUMBER TRADE NAME APPLICANT ACTIVE INGREDIENT(S) APPROVAL DATE (DOSAGE FORM) STRENGTH(S) (CLASSIFICATION) CLASSIFICATION(S) ***ORIGINAL AND SUPPLEMENTAL NDAs*** FOR NEW DRUG PRODUCTS 20-132 IMITREX GLAXO WELLCOME SUMATRIPTAN SUCCINATE 01-JUN-95 (TABLET) RES TRIANGLE PK, NC EQ 25MG BASE (3 S) 27709 EQ 50MG BASE EQ...
DDPA May 1995 DEPARTMENT OF HEALTH AND HUMAN SERVICES, PUBLIC HEALTH SERVICE NDA NUMBER TRADE NAME APPLICANT ACTIVE INGREDIENT(S) APPROVAL DATE (DOSAGE FORM) STRENGTH(S) (CLASSIFICATION) CLASSIFICATION(S) ***ORIGINAL AND SUPPLEMENTAL NDAs*** FOR NEW DRUG PRODUCTS 19-915 MONOPRIL BRISTOL MYERS SQUIBB FOSINOPRIL SODIUM 02-MAY-95 (TABLET) PRINCETON, NJ 10MG (SUPPL-009) 08543 20MG 40MG (NEW INDICATION...
http://www.fda.gov/cder/foi/label/2002/20212se7-004,005,006lbl.pdf 50 SUMMARY OF MEAN (% CV a ) DEXRAZOXANE 51 PHARMACOKINETIC PARAMETERS AT A DOSAGE RATIO OF 52 10: 1 OF ZINECARD: DOXORUBICIN 53 54 Dose Doxorubicin (mg/ m 2 ) Dose Zinecard (mg/ m 2 ) Number of Subjects Elimination Half- Life (h) Plasma Clearance (L/ h/ m 2 ) Renal Clearance (L/ h/ m 2 ) b Volume of Distribution (L/ m 2 ) 50 500 10 2.5 (16) 7.88 (18) 3.35 (36) 22.4...
http://www.fda.gov/cder/foi/label/2002/20212se7-004,005,006lbl.pdf page 6
http://www.fda.gov/cder/foi/label/2002/20212se7-004,005,006lbl.pdf page 2
http://www.fda.gov/cder/foi/label/2002/20212se7-004,005,006lbl.pdf page 1
Cancer Care Ontario Formulary Information for patients, health professionals and public on cancer prevention, screening, treatment (radiation, chemotherapy, surgery), supportive care, research, education, and standards and guidelines ...
http://www.cancercare.on.ca/formulary/pdfmedicationinfo/Dexrazoxane.pdf For more information on this medication, please call your doctor or nurse, or the Cancer Centre Drug Information pharmacist. MEDICATION INFO SHEET DEXRAZOXANE (decks- raz- OX- ane) Other Names for this Medication: Zinecard (Brand Name) ADR- 529, ICRF- 187( Other Names) Appearance: Injection: ...
http://www.cancercare.on.ca/formulary/pdfmedicationinfo/Dexrazoxane.pdf page 1 For more information on this medication, please call your doctor or nurse, or the Cancer Centre Drug Information pharmacist. MEDICATION INFO SHEET DEXRAZOXANE (decks- raz- OX- ane) Other Names for this Medication: Zinecard (Brand Name) ADR- 529, ICRF- 187( Other Names) Appearance: Injection: ...
http://www.fda.gov/cder/dmf/text/4Q2003ACTIVETYPE2TEXT.txt "DEXRAZOXANE AS MFG IN PETERSBURG,VA." 15187 07-Dec-00 CHEMAGIS LTD "MOMETASONE FUROATE AS MFG IN BE'ER SHEVA,ISRAEL" 15191 15-Dec-00 LECIVA AS "TETRAHYDROZOLINE HYDROCHLORIDE USP,AS MFG IN PRAHA,CZECH REPUBLIC." 15192 18-Dec-00 RANBAXY LABORATORIES LTD "CEFPODOXIME PROXETIL AS MFG IN PUNJAB,INDIA" 15193 19-Dec-00 API CORPORATION "MYCOPHENOLIC ACID, TECHNICAL GRADE ...
Drug Approvals - Z NDA 19-090/S-0037 10/29/99 - 4/16/03 Zantac (ranitidine hydrochloride) Injection & Premixed Injection GlaxoSmithKline NDA 19-090/S-045 & 19-593/S-033 1/7/02 2/8/02 Zantac (ranitidine hydrochloride) Tablets, Syrup, USP, GELdose Capsules & EFFERdose Tablets and Granules GlaxoSmithKline NDA 18-703/S-061, 19-675/S-025, 20-095/S-013 & 20-251/S-011 1/7/02 2/8/02 Zantac (Ranitidine ...
