Abbreviated New Drug Application (ANDA) 76-329
Approval date: 11/6/02
Name: Amcinonide Lotion USP, .1%
Type: Generic approval for Cyclocort
Applicant: Altana, Inc.
OTC/RX status: RX
Indication of Use: Synthetic steroids primarily indicated used as anti-pruritic and anti-inflammatory agents.
ANDA 76-096
Approval date: 11/19/02
Name: Amcinonide Ointment USP, .1%
Type: Generic approval of Cyclocort
Applicant: Altana, Inc.
OTC/RX: RX
Indication of Use: Synthetic steroids primarily indicated as anti-pruritic and anti-inflammatory agents.
New Drug Application 75-945
Approval Date: 11/8/02
Name: Amnesteem
Type: Generic approval of isotretinoin
Dosage form: 10, 20, & 40 mg capsules
Applicant: Genpharm, Inc.
OTC/RX: RX
New Drug Application 21-015/S4
Approval Date: 10/22/02
Trade Name: AndroGel
Active Ingredient: Testosterone gel
Applicant: Unimed Pharmaceuticals, Inc.
OTC/RX: RX
Indication of Use: AndroGel is indicated for replacement therapy in therapy in males for conditions associated with a deficiency or absence of endogenous testosterone.
New Drug Application 21-319/S-001
Approval Date: 10/9/02
Trade Name: Avodart
Main Ingredient: Dutasteride
Applicant: GlaxoSmithKline
OTC/RX: RX
Dosage form: capsules
Indications of Use: Inhibits the conversion of testosterone to 5-alpha dihydrotestosterone (DHT), indicated for use in treatment of benign prostate hyperplasia.
ANDA 76-075
Name: Econazole Nitrate 1% cream
Approval Date: 11/26/02
Type: Generic approval
Applicant: Altana Inc.
OTC/RX: RX
ANDA 76-005
Name: Econazole Nitrate 1% cream
Approval Date: 11/26/02
Type: Generic approval
Applicant: Taro Pharmaceuticals
OTC/RX: RX
ANDA 75-990
Name: Loratadine Orally Disintegrating Tablets
Approval Date: 11/15/02
Applicant: Andrx Pharmaceuticals, Inc.
Dosage form: 10mg capsules
OTC/RX: RX
ANDA 75-183
Name: Prednisolone Sodium Phosphate Oral solution
Approval Date: 10/17/02 (tentative)
Type: Generic approval
Dosage form: Oral solution, 5mg (base/5mL)
Applicant: Hi-Tech Pharmacal Co., Inc.
OTC/RX: RX
NDA 21-454
Name: Testim 1% gel
Approval Date: 10/31/02
Active Ingredient: Testosterone
Dosage Form: 50 mg and 100 mg
Applicant: Auxilium Pharmaceuticals, Inc.
Indications for Use: Testim is indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone.
NDA 65-113
Name: Amoxicillin Oral Suspension
Approval Date: 11/29/02
Type: Generic approval of Amoxil Oral Suspension
Dosage Form: 200 mg / 5 mL and 400 mg / 5 mL
Applicant: Ranbaxy Laboratories Ltd.
COPYRIGHT 2003 Journal of Drugs in Dermatology
COPYRIGHT 2003 Gale Group
Contact
Home
A
Dacarbazine