Details for New Drug Application (NDA): 065067
✉ Email this page to a colleague
The generic ingredient in CLINDAMYCIN PHOSPHATE is clindamycin phosphate; tretinoin. There are fifty-five drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the clindamycin phosphate; tretinoin profile page.
Summary for 065067
Tradename: | CLINDAMYCIN PHOSPHATE |
Applicant: | Fougera Pharms |
Ingredient: | clindamycin phosphate |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 065067
Physiological Effect | Decreased Sebaceous Gland Activity Neuromuscular Blockade |
Suppliers and Packaging for NDA: 065067
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
CLINDAMYCIN PHOSPHATE | clindamycin phosphate | LOTION;TOPICAL | 065067 | ANDA | E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. | 0168-0203 | 0168-0203-60 | 1 BOTTLE in 1 CARTON (0168-0203-60) / 60 mL in 1 BOTTLE |
CLINDAMYCIN PHOSPHATE | clindamycin phosphate | LOTION;TOPICAL | 065067 | ANDA | Bryant Ranch Prepack | 72162-2147 | 72162-2147-6 | 1 BOTTLE in 1 CARTON (72162-2147-6) / 60 mL in 1 BOTTLE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | LOTION;TOPICAL | Strength | EQ 1% BASE | ||||
Approval Date: | Jan 31, 2002 | TE: | AB | RLD: | No |
Complete Access Available with Subscription