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...
20-715_Trelstar Food and Drug Administration • Center for Drug Evaluation and Research Title Search Trelstar Depot (Triptorelin Pamoate) Injection Company:--Debio Recherche Pharmaceutique S.A
author: USERNAME
21-288_Trelstar Depot (Triptorelin Pamoate) Injection Food and Drug Administration • Center for Drug Evaluation and Research Approval Package Search Trelstar Depot (Triptorelin Pamoate) Injection Company:--Debio Recherche Pharmaceutique S.A
author: Paul Stauffer
NMEs Approved in CY 2000 NMEs Approved in Calendar Year 2000 NDA Number Generic Name- Trade Name Dosage Form Applicant - --- Classification- Approval Date 20-989 Cevimeline HCl Evoxac Capsule Snowbrand 1S 01-11-2000 21-014 Oxcarbazepine Trileptal Tablet Novartis Pharms 1S 01-14-2000 20-987 Pantoprazole Sodium Protonix Tablet Wyeth Ayerst 1S 02-02-2000 21-107 Alosetron HC1 Lotronex Tablet Glaxo Wellcome 1P 02...
author: Susan Daugherty
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 Dosage...
Prescription and OTC Drug Product List 6/2000 Prescription and Over-the-Counter Drug Product List - 20th Edition Cumulative Supplement Number 6: June 2000 [ Prescription - OTC ] ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETOHEXAMIDE BLEOMYCIN SULFATE TABLET; ORAL INJECTABLE; INJECTION ACETOHEXAMIDE BLEOMYCIN - DLT - AB BARR 500MG N70870 001 - ADD - AP GENSIA SICOR PHARMS EQ 15 UNITS BASE/VIAL N65033 001 - DLT - FEB...
NDA Approvals for Calendar Year 2001 Braun 5 S 21-Feb-01 21-235 Prozac Weekly Fluoxetine Hydrochloride Eli Lilly 3 S 26-Feb-01 21-169 Reminyl Galantamine Hydrobromide Janssen Research 1 S 28-Feb-01 21-082 Tavist Allergy/Sinus/Headache Acetaminophen/Clemastine Fumarate/Pseudoephedrine Hydrochloride Novartis 4 S 01-Mar-01 21-257 Travatan Travoprost Alcon 1 P 16-Mar-01 21-262 Alphagan P Brimonidine Tartrate Allergan 3 S 16...
author: Brenda Harmon
FDA Drug Approvals List June 2001 - Drug Approvals for June 2001 Definitions and Notes Original New Drug Applications Original Application #: 021288 Approval Date: 29-JUN-01 Trade Name: TRELSTAR Chemical Type: 3 Therapeutic Potential: S Dosage Form: INJECTABLE Applicant: DEBIO RECHERCHE PHARMACEUTIQUE SA Active Ingredient(s): TRIPTORELIN PAMOATE OTC/RX Status: RX Indication(s): For the palliative...
Prescription and OTC Drug Product List 9/2001 ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST TABLET; ORAL HYDROCODONE BITARTRATE AND ACETAMINOPHEN -D- ENDO PHARMS 400MG;5MG N40288 001 NOV 27, 1998 SEP CTEC -D- 400MG;7.5MG N40288 002 NOV 27, 1998 SEP CTEC -D- 400MG;10MG N40288 003 NOV 27, 1998 SEP CTEC -A- + 400MG;5MG N40288 001 NOV 27, 1998 SEP CTEC -A- + 400MG;10MG N40288 003 NOV 27, 1998 SEP CTEC -A- + 400MG;7.5MG...
1997 Warning Letters and Notice of Violation Letters to Pharmaceutical Companies Food and Drug Administration • Center for Drug Evaluation and Research Compliance Activities Search Warning Letters and Untitled Letters to Pharmaceutical Companies 1997 These letters, sorted by month, are supplied by the CDER Freedom of Electronic Information Office
FDA Drug Approvals List June 2000 - Drug Approvals for June 2000 Definitions and Notes Original New Drug Applications Original Application #: 020715 Approval Date: 15-JUN-00 Trade Name:TRELSTAR DEPOT Chemical Type: 1 Therapeutic Potential: S Dosage Form: INJECTABLE Applicant: DEBIO RECHERCHE PHARMACEUTIQUE SA Active Ingredient(s): TRIPTORELIN PAMOATE OTC/RX Status: RX Indication(s): For the...
LH-RH agonists/GnRH agonists for prostate cancer - [Medication] - Quest Diagnostics Patient Health Library Topic Contents - Examples - How It Works - Why It Is Used - How Well It Works - Side Effects - What To Think About - References LH-RH agonists/GnRH agonists for prostate cancer - [Medication] - Quest Diagnostics Patient Health Library LH-RH agonists/GnRH agonists for prostate cancer - [Medication] - Quest Diagnostics Patient Health Library Cancer, Hormones, Men’s health, Sexual...
LH-RH agonists/GnRH agonists for prostate cancer - [Medication] - Quest Diagnostics Patient Health Library Topic Contents - Examples - How It Works - Why It Is Used - How Well It Works - Side Effects - What To Think About - References LH-RH agonists/GnRH agonists for prostate cancer - [Medication] - Quest Diagnostics Patient Health Library LH-RH agonists/GnRH agonists for prostate cancer - [Medication] - Quest Diagnostics Patient Health Library Cancer, Hormones, Men’s health, Sexual...
http://www.paladin-labs.com/pdf_files/Trelstar_Primer.pdf 1 Trelstar ® 2 Trelstar ° Triptorelin pamoate – LHRH agonist ° Approved in Canada for the treatment of endometriosis and prostate cancer but never launched ° Available in two formats: 1 and 3 month IM injection ° Marketed in Europe as Decapeptyl ° Approved in US and just launched by Watson ° Competes in a growing market of ...
Reference Listed Drug Labeling Approved in January 2002 Approval Date Product Name Active Ingredient(s) Dosage Form NDA No Supp No Jan 2 CEREBYX letter label fosphenytoin Na injection 20-450 S-007 -- VIAGRA letter label sildenafil citrate tablet 20-895 S-012 Jan 3 FOCALIN letter label dexmethylphenidate HCl tablet 21-278 S-001 --- NARDIL letter label phenelzine sulfate tablet 11-909 S-030 --- TOFRANIL-PM letter label imipramine pamoate...
author: USERNAME
Report to the Nation: Drug Review Priority new drug approvals (N=NME) Abacavir/lamivudine/zidovudine (Trizivir) Alosetron (Lotronex) (N) Arsenic trioxide (Trisenox) (N) Atovaquone/proquanil (Malarone) Bexarotene (Targetin) Budesonide (Pulmicort) Didanosine (Videx EC) Gentuzumab ozogamicin (Mylotarg) (N) Levobetaxolol (Betaxon) Levofloxacin (Quixin) Linezolid (Zyvox) (3 NDAs approved, 1 as NME) (N) Lopinavir/ritonavir...
author: OLIVERN
http://www.fda.gov/cder/foi/appletter/2002/20715s4ltr.pdf page 1
duplicates:http://www.fda.gov/cder/foi/appletter/2002/20715s3ltr.pdf
Debio - Products Information on products and current product pipeline. ...
Debio - News Latest news and events from Debiopharm, Debio R.P. and Debioclinic. ...
Debio - Milestones Debio: Developing innovative therapeutics, a Swiss-based integrated pharmaceutical development group. ...
Fourre A4 developing innovative therapeutics Eloxatine ® Trelstar ® Decapeptyl ® a Sanofi- Synthélabo a Pharmacia Corporation a Debiopharm, Beaufour Ipsen & Ferring trademark trademark Pharmaceuticals trademark ...
author: Beno t Buzzi - fgdesign
http://www.phrma.org/newmedicines/resources/2001-01-10.11.pdf Army Medical for use against chemical 8/ 19/ 99 2/ 17/ 00 6.0 months none Reduction Paste Research and Material warfare agents only in Against Chemical Command conjunction with Mission Warfare Agents Fort Detrick, MD Oriented Protective Posture (SERPACWA) gear to reduce or delay (P) the absorption of chemical warfare agents through the skin when paste is applied prior to exposure For...
http://www.phrma.org/newmedicines/resources/2001-01-10.11.pdf page 10
http://www.phrma.org/newmedicines/resources/2001-01-10.11.pdf page 5
00-354 2000 PhRMA NDA 01/17 Army Medical for use against chemical 8/ 19/ 99 2/ 17/ 00 6.0 months none Reduction Paste Research and Material warfare agents only in Against Chemical Command conjunction with Mission Warfare Agents Fort Detrick, MD Oriented Protective Posture (SERPACWA) gear to reduce or delay (P) the absorption of chemical warfare agents through the skin when paste is applied prior to exposure For...
author: RL
