material_safety_data_sheet_letter_new_.doc ALLERGAN 2525 Dupont Drive, P.
author: hutton_ronald
material_safety_data_sheet_letter_new_.doc page 1
author: hutton_ronald
Drug Approvals - A This newly approved or tentatively approved drug listing is an interim page intended to provide timely information on new drug products as a more comprehensive page is developedACULAR (ketorolac tromethamine) ophthalmic solution, 0.5% Allergan NDA 19700/S18 7/6/01 ...
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,...
NDA Approvals for Calendar Year 2003 NDA APPROVALS FOR CALENDAR YEAR 2003 Updated through December 31, 2003 NDA NUMBER DRUG NAME GENERIC NAME APPLICANT/ SPONSOR CHEMICAL TYPE THERAPEUTIC CLASS APPROVAL DATE - 21434 Xanax XR Alprazolam Pharmacia and Upjohn FR 3 S 17-Jan-03 21305 Sodium Iodide I-131 Sodium Iodide I-131 DraxImage 3,5 S 24-Jan-03 20414 Pyridostigmine Bromide Pyridostigmine Bromide US Army 3 P 05-Feb-03...
author: Susan Daugherty
Prescription and Over-the-Counter Drug Product List: 5/2003 ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; BUTALBITAL; CAFFEINE TABLET; ORAL BUTALBITAL, APAP, AND CAFFEINE -A- AB AXIOM PHARM 325MG;50MG;40MG N89536 001 FEB 16, 1988 MAY CAHN -D- AB HALSEY 325MG;50MG;40MG N89536 001 FEB 16, 1988 MAY CAHN ACETAMINOPHEN; HYDROCODONE BITARTRATE TABLET; ORAL HYDROCODONE BITARTRATE AND ACETAMINOPHEN -A- AA ABLE 500MG;7.5MG...
author: AUTHOR
Drug Approval Package FDA Home Page | CDER Home Page | CDER Site Info | Contact CDER | What's New @ CDER - Search - -Acular LS (Ketorolac Tromethamine) Ophthalmic Solution Company:- Allergan 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...
1997 Warning Letters and Notice of Violation Letters to Pharmaceutical Companies Johnson DDMAC 9/24/1997 5/29/1998 Posicor (Mibefradil Dihyrdrochloride) Tablets Hoffman-La Roche DDMAC 9/5/1997 5/29/1998 Salagen (Pilo carpine HCl) MGI Pharma DDMAC 9/24/1997 5/29/1998 Site Inspection Gedeon Richter, Ltd DMPQ 9/5/1997 9/24/1997 Zocor (Simvastatin) Merck DDMAC 9/22/1997 5/29/1998 October 1997 Accolate (Zafirkulast) Tablets Zeneca Pharmaceuticals DDMAC 10/1/1997 5/22...
1998 Warning Letters and Untitled Letters to Pharmaceutical Companies DDMAC 6/25 6/29 Maxipime (Cefepime HCl) for Injection Bristol-Myers Squibb DDMAC 6/29 8/3 Mircette (Desogestrel/Ethinyl Estradiol and Ethinyl Estradiol) Tablets Organon DDMAC 6/1 6/9 Naprelan (Naproxen Sodium) Tablets Wyeth-Ayerst DDMAC 6/8 6/29 Nasacort (Triamcinolone Acetonide) Rhone-Poulenc Rorer DDMAC 6/25 6/29 Nasonex (mometasone furoate monohydrate) nasal spray Schering...
1997 New Drug Application (NDA) Approved Posted Aceon Capsules/Perindoppril Erbumine 2 mg, 4mg and 8 mg [940 KB] Rhone Poulenc Roher 020184/S003 1/8/1997 3/20/1998 Acephen G & W Labs 018060/S55 03/31/1997 9/11/2003 Acular PF/Ketorolac Tromethamine [5.5 MB] Hoffman-LaRoche 020811 11/3/1997 3/20/1998 Alesse Wyeth-Ayerst Laboratories 020683 3/27/1997 8/13/03 Allegra-D/Fenofenadine/pseudoephedrine Approval...
FDA Drug Approvals List April 2001 - Drug Approvals for April 2001 Definitions and Notes Original New Drug Applications Original Application #: 020949 Approval Date: 30-APR-01 Trade Name: ACCUNEB Chemical Type: 5 Therapeutic Potential: S Dosage Form: SOLUTION Applicant: DEY LABORATORIES INC Active Ingredient(s): ALBUTEROL SULFATE OTC/RX Status: RX Indication(s): For the treatment of asthma-related bronchospasm in...
FDA Drug Approvals List February 2002 - Drug Approvals for February 2002 Definitions and Notes Original New Drug Applications Original Application #: 020982 Approval Date: 12-FEB-02 Trade Name: PAXIL CR Chemical Type: 6 Therapeutic Potential: S Dosage Form: TABLET Applicant: SMITHKLINE BEECHAM PHARMACEUTICALS Active Ingredient(s): PAROXETINE HYDROCHLORIDE OTC/RX Status: RX Indication(s): For the treatment of Panic...
Prescription and OTC Drug Product List 11/1997 Prescription and Over-the-Counter Drug Product List - 17th Edition Cumulative Supplement Number 11: Jan '97 - Nov '97 [ Prescription - OTC ] ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACARBOSE AMANTADINE HYDROCHLORIDE TABLET; ORAL CAPSULE; ORAL PRECOSE - DLT - SYMADINE - DLT - BAYER 25MG N20482 004 - DLT - AB SOLVAY 100MG N71000 001 - DLT - MAY 29, 1997 - DLT - SEP 04,...
FDA Drug Approvals List July 2000 - Drug Approvals for July 2000 Definitions and Notes Original New Drug Applications Original Application #: 050779 Approval Date: 27-JUL-00 Trade Name: CEFAZOLIN AND DEXTROSE Chemical Type: 5 Therapeutic Potential: S Dosage Form: INJECTABLE Applicant: B BRAUN MEDICAL INC Active Ingredient(s): CEFAZOLIN SODIUM OTC/RX Status: RX Indication(s): For the treatment of respiratory tract...
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...
Drug Approvals September 1996 Drug Approvals for September 1996 Definitions and Notes Original New Drug Applications Original Application #: 020592 Approval Date: 30-SEP-96 Trade Name: ZYPREXA Chemical Type: 1 Therapeutic Potential: S Dosage Form: TABLET Applicant: ELI LILLY AND CO Active Ingredient(s): OLANZAPINE OTC/RX Status: RX Indication(s): MANAGEMENT OF THE MANIFESTATIONS OF PSYCHOTIC DISORDERS Original...
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...
Allergan Skip to content Global Locations- Contact Us- Search- About Us- History Leadership Global Locations What We Treat- Eye Care: Dry Eye Glaucoma Other Eye Conditions Neurosciences: Blepharospasm Cervical Dystonia Strabismus Obesity Intervention Medical Aesthetics: Breast Aesthetics Facial Aesthetics Medical Dermatology: Acne Psoriasis Severe Primary Axillary Hyperhidrosis Other Skin...
author: PINT [ www.pint.com ]
Microsoft Word - APC100752006.doc External Disease Portfolio Fact Sheet Allergan offers a portfolio of external disease products that includes ZYMAR ® , ACULAR LS ® , and PRED FORTE ®.ACULAR LS ® (ketorolac tromethamine ophthalmic solution) 0.ACULAR LS ® is a prescription eye drop indicated for the reduction of ocular pain and burning/...
author: katt_heather
Microsoft Word - APC100752006.doc page 1
author: katt_heather
Inspire Pharmaceuticals, Inc. PR Title NEWS RELEASE ALLERGAN AND INSPIRE ENTER INTO COLLABORATION TO CO-PROMOTE ELESTAT™ IN THE U.S.
N:\EYE\Allergan-N21528(Keto-0.4)8-6-02.doc\N21528AP.doc NDA 21- 528 Page 3 ACULAR LS (ketorolac tromethamine ophthalmic solution) 0.4% Sterile DESCRIPTION ACULAR LS (ketorolac tromethamine ophthalmic solution) 0.4% is a member of the pyrrolopyrrole group of nonsteroidal anti- inflammatory drugs (NSAIDs) for ophthalmic useACULAR LS ophthalmic solution is a racemic mixture of R-(+) and S-(...
author: Raphael Rodriguez
N:\EYE\Allergan-N21528(Keto-0.4)8-6-02.doc\N21528AP.doc page 4
author: Raphael Rodriguez
