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 ACTHAR GEL, CORTICOTROPIN H.R.-50, HYDROCHLOROTHIAZIDE HABITROL, NICOTINE (OTC) HALCION, TRIAZOLAM HALDOL SOLUTAB, HALOPERIDOL HALDOL, HALOPERIDOL HALDOL, HALOPERIDOL DECANOATE HALDOL, HALOPERIDOL LACTATE HALDRONE, PARAMETHASONE ACETATE HALFAN, HALOFANTRINE HYDROCHLORIDE HALOG, HALCINONIDE HALOG-E, HALCINONIDE HALOPERIDOL DECANOATE, HALOPERIDOL DECANOATE HALOPERIDOL INTENSOL,...
FDA Drug Approvals List June 2001 PERRIGO COMPANY Active Ingredient(s): MONOXIDIL OTC/RX Status: RX Original Abbreviated Application # 075750 Approval Date: 8-JUN-01 Trade Name: DOXAZOSIN MESYLATE Dosage Form: TABLET Applicant: SIDMAK LABORATORIES, INC Active Ingredient(s): DOXAZOSIN MESYLATE OTC/RX Status: RX Original Abbreviated Application # 075502 Approval Date: 05-JUN-01 Trade Name: CLOTRIMAZOLE AND...
FDA Drug Approvals List February 2001 Dosage Form: INJECTABLE Applicant: ASTRAZENECA UK LTD Active Ingredient(s): MEROPENEM OTC/RX Status: RX Application #: 050622 Labeling Supplement #: 014 To Original New Drug Application Approval Date: 06-FEB-01 Trade Name: SUPRAX Dosage Form: SUSPENSION Applicant: LEDERLE LABORATORIES DIV AMERICAN CYANAMID CO Active Ingredient(s): CEFIXIME OTC/RX Status: RX Application #: 050606...
FDA Drug Approvals List May 2002 - Drug Approvals for May 2002 Definitions and Notes Original New Drug Applications Original Abbreviated Antibiotic Application # 065082 Approval Date: 31-MAY-02 Trade Name: CEFPODOXIME PROXETIL Dosage Form: GRANULE, FOR RECONSTITUTION Applicant: RANBAXY LABORATORIES LTD Active Ingredient(s): CEFPODOXIME PROXETIL OTC/RX Status: RX Original Application #: 021292 Approval Date: 31-MAY...
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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...
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...
Drug and Device Approvals March 1995 20-386 COZAAR MERCK LOSARTAN POTASSIUM 02-MAR-95 (TABLET) WEST POINT, PA 25MG 19486 50MG (ANGIOTENSIN II RECEPTOR ANTAGONIST) [HYPERTENSION] 20-169 NILANDRON BESSELAAR ASSOC NILUTAMIDE 07-MAR-95 (TABLET) PRINCETON, NJ 50MG 08540 (ANTIANDROGEN) [METASTATIC PROSTATE CANCER] 20-173 TRAVASOL 5.5% BAXTER AMINO ACIDS 09-MAR-95 W/ELECTROLYTES ROUND LAKE, IL 5.5% [SULFITE-FREE] 60073...
DDPA May 1996 Drug and Device Product Approvals for May 1996 ***ORIGINAL AND SUPPLEMENTAL NDAs*** FOR NEW DRUG PRODUCTS 16-191 SORBITRATE ZENECA ISOSORBIDE DINITRATE 01-APR-96 (TABLET, SUBLINGUAL) WILMINGTON, DE 2.5MG (SUPPL-033) 19850 5MG (VASODILATOR) [MET CONDITIONS FOR APPROVAL PER FEDERAL REGISTER NOTICE OF AUGUST 3, 1984 (49 FR 31151)] 16-192 SORBITRATE ZENECA ISOSORBIDE DINITRATE 01-APR-96 ...
Drug Approvals December 1996 Drug Approvals for December 1996 Definitions and Notes December 1996 Original New Drug Applications Original Application #: 020681 Approval Date: 31-DEC-96 Trade Name: ORTHO TRI-CYCLEN Chemical Type: 6 Therapeutic Potential: S Dosage Form: TABLET Applicant: RW JOHNSON PHARMACEUTICAL RESEARCH INSTITUTE DIV ORTHO PHARMACEUTICAL CORP Active Ingredient(s): ETHINYL ESTRADIOL; NORGESTIMATE...
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http://www.fda.gov/cder/dmf/text/4Q2003NEWTEXT.txt CHINA." 16892 V 3-Sep-2003 ALTHEA TECHNOLOGIES INC "ASEPTIC FORMULATION, FILL, AND FINISH FACILITY IN SAN DIEGO, CA." 16893 III 15-Sep-2003 ERIE MOLDED PLASTICS INC "LID FOR DEODORANT AS MANUFACTURED IN ERIE, PA." 16894 II 5-Oct-2003 DIVIS LABORATORIES LTD "LEVITERACETAM AS MANUFACTURED IN ANDHRA PRADESH, INDIA." 16895 IV 6-Oct-2003 FIRMENICH INC "NATURAL & ARTIFICIAL ORANGE FLAVOR...
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Efficacy Supplements Approved in Calendar Year 1998 EFFICACY SUPPLEMENTS APPROVED IN CY 98 GENERIC NAME APPLICANT NDA NUMBER RECEIPT DATE APPROVAL DATE SUPPLEMENT TYPE TOTAL APPROVAL TIME (MONTHS) INDICATION/DESCRIPTION ACARBOSE BAYER 20-482 30-Sep-97 29-Sep-98 SE1 12.0 For patients with type 2 diabetes treated with diet plus insulin
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THE MERCK MANUAL OF GERIATRICS, App. III, Trade Names of Some Commonly Used Drugs, GANTANOL to LYSODREN Trade Names of Some Commonly Used Drugs TRADE AND GENERIC NAMES OF COMMONLY USED DRUGS GANTANOL to LYSODREN Trade Name Generic GANTANOL Sulfamethoxazole GANTRISIN Sulfisoxazole GARAMYCIN Gentamicin GEOCILLIN Carbenicillin GLUCOPHAGE Metformin GLUCOTROL Glipizide GRIFULVIN V Griseofulvin GRISACTIN Griseofulvin HALCION Triazolam HALDOL Haloperidol HALDRONE Paramethasone HALOTESTIN...
THE MERCK MANUAL OF GERIATRICS, App. III, Trade Names of Some Commonly Used Drugs. Salmeterol to Zolpidem Trade Names of Some Commonly Used Drugs GENERIC AND TRADE NAMES OF COMMONLY USED DRUGS Salmeterol to Zolpidem Generic Trade Name Salmeterol SEREVENT Salsalate DISALCID, SALFLEX Saquinavir FORTOVASE Sargramostim LEUKINE Secobarbital SECONAL Selegiline ELDEPRYL Selenium SELSUN Sertraline ZOLOFT Sibutramine MERIDIA Sildenafil VIAGRA Silver sulfadiazine SILVADENE Simethicone MYLICON...
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