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...
2003 Warning Letters and Untitled 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 2003 These letters, sorted by month, are supplied by the CDER Freedom of Electronic Information Office
author: STAUFFERP
NMEs Approved in CY 1999 NMEs Approved in Calendar Year 1999 NDA Number Generic Name- Trade Name Dosage Form Applicant - --- Classification- Approval Date - - - - - - - 20-863 Cilostazol Pletal Tablet Otsuka Pharm 1S 01-15-1999 20-886 Alitretinoin Panretin Topical Gel Ligand Pharm 1-PV 02-02-1999 20-955 Sodium Ferric Gluconate Complex Ferrlicit Injectable R&D Labs 1P 02-18-1999 21-007 Amprenavir Agenerase...
author: Elaine Abraham
C:\Data\My Documents\Jenni s Work Files\Products\Solage Topical Sol\ ution_11296\NOV_11668_081903_PtTearSheet.doc 14501 North Freeway Fort Worth, TX 76177- 3304 RE: NDA 20- 922 Solage (mequinol 2%, tretinoin 0.01%) Topical Solution MACMIS ID#: 11668 Dear MsSolage 's approved product labeling (PI) regarding the contraindication in women of childbearing potential and thereby minimizes the risk associated with...
author: Jennifer Murphy
C:\Data\My Documents\Jenni s Work Files\Products\Solage Topical Sol\ ution_11296\NOV_11668_081903_PtTearSheet.doc page 1
author: Jennifer Murphy
Prescription and OTC Drug Product List 4/2002 ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE CAPSULE; ORAL ACETAMINOPHEN, BUTALBITAL, CAFFEINE, AND CODEINE PHOSPHATE -A- AB VINTAGE PHARMS 325MG;50MG;40MG;30MG N75929 001 APR 22, 2002 APR NEWA ALPHA-TOCOPHEROL ACETATE; ASCORBIC ACID; BIOTIN; CHOLECALCIFEROL; CYANOCOBALAMIN; DEXPANTHENOL; FOLIC ACID; NIACINAMIDE;...
Microsoft Word - Solage Press Release - MM Revised.doc FDA Approved Product Helps Baby Boomers Minimize Sun Damage Galderma Introduces Solage ® (mequinol 2%, tretinoin 0.01%) Topical Solution for Solar Lentigines Fort Worth, Texas – February 18, 2003 – Galderma Laboratories, L
Microsoft Word - Solage Press Release - MM Revised.doc page 3
Microsoft Word - Solage Press Release - MM Revised.doc page 2
Microsoft Word - Solage Press Release - MM Revised.doc page 1
Solage Consumer Information Solage® Brand Name: Solage® Active Ingredient: - mequinol and tretinoin Strength(s): 2% and 0.01% Dosage Form(s): - Topical solution Company Name: -- Galderma Laboratories- Availability: ------- Prescription only *Date Approved by FDA: - December 10, 1999 *Approval by FDA does not mean that the drug is available for consumers at this timeSolage ...
FY 2000 USER FEE NME APPROVALS FY 2000 USER FEE NME APPROVALS - NDA# Trade Name (Generic Name) Dosage Form Applicant Date of Approval Class Indications(s) - 20-931 Tikosyn (dofetilide) Capsules Pfizer 01-Oct-99 1S Tikosyn is indicated for the conversion of atrial fibrillation and atrial flutter to normal sinus rhythmSolage (mequinol, tretinoin) Topical Solution Bristol-Myers Squibb 10...
author: Brenda Harmon
FDA Drug Approvals List December 1999 Original Application #: 020845 Approval Date: 23-DEC-99 Trade Name: INOMAX Chemical Type: 1 Therapeutic Potential: P Dosage Form: INHALATION Applicant: INO THERAPEUTICS INC Active Ingredient(s): NITRIC OXIDE OTC/RX Status: RX Indication(s): For the treatment of term and near-term (-34 weeks) neonates with hypoxic respiratory failure associated with clinical or echocardiographic...
CDER 1999 Report to the Nation 1999 new molecular entities: Alitretinoin (Panretin) Aminolevulinic acid hydrochloride (Levulan Kerastick) Amprenavir (Agenerase) Bexarotene (Targretin) Cilostazol (Pletal) Dalfopristin/ quinupristin (Synercid) Dexmedetomidine hydrochloride (Precedex) Dofetilide (Tikosyn) Doxercalciferol (Hectorol) Entacapone (Comtan) Epirubicin hydrochloride (Ellence) Exemestane (Aromasin)...
author: Center for Drug Evaluation and Research
subject: Improving Public Health Through Human Drugs
CDER 1999 Report to the Nation page 11
author: Center for Drug Evaluation and Research
subject: Improving Public Health Through Human Drugs
http://www.fda.gov/cder/foi/label/1999/20922lbl.pdf Solage (mequinol, 2%, tretinoin, 0.01%) Topical Solution is indicated for the treatment of solar lentigines
http://www.fda.gov/cder/foi/label/1999/20922lbl.pdf page 2
http://www.fda.gov/cder/foi/appletter/1999/20922ltr.pdf page 1
20-922_Solage Food and Drug Administration • Center for Drug Evaluation and Research Title Search Solage (Mequinol 2%/Tretinoin,.01%) Topical Solution Company:--Bristol-Myers Squibb Pharmaceutical Research Institute Application No.:--20-922 Approval Date:-12/10/1999 Approval Letter(s) - Printed Labeling - Medical Review(s)- Part 1 - Part 2 - Chemistry Review(s) - Pharmacology...
author: USERNAME
http://www.fda.gov/cder/foi/appletter/1999/20922ltr.pdf page 2
Galderma September 25, 2003-- - Hormonal Acne Rosy Cheeks Hot Flash How Do Women Feel About The Appearance Of Their Skinmequinol 2%, tretinoin 0.01%) Topical Solution for Solar Lentigines Fort Worth, Texas - February 18, 2003 - Galderma Laboratories, L.P
http://www.fda.gov/cder/foi/label/1999/20922lbl.pdf page 9
http://www.fda.gov/cder/foi/label/1999/20922lbl.pdf page 8
http://www.fda.gov/cder/foi/label/1999/20922lbl.pdf page 7
http://www.fda.gov/cder/foi/label/1999/20922lbl.pdf page 6
