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Details for New Drug Application (NDA): 050615
NDA 050615 describes CLEOCIN T, which is a drug marketed by Pharmacia And Upjohn and is included in four NDAs. It is available from two suppliers. Additional details are available on the CLEOCIN T profile page.
The generic ingredient in CLEOCIN T is clindamycin phosphate. There are fifty-five drug master file entries for this compound. Thirty-eight suppliers are listed for this compound. Additional details are available on the clindamycin phosphate profile page.
The generic ingredient in CLEOCIN T is clindamycin phosphate. There are fifty-five drug master file entries for this compound. Thirty-eight suppliers are listed for this compound. Additional details are available on the clindamycin phosphate profile page.
Summary for 050615
| Tradename: | CLEOCIN T |
| Applicant: | Pharmacia And Upjohn |
| Ingredient: | clindamycin phosphate |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 050615
| Physiological Effect | Decreased Sebaceous Gland Activity |
Suppliers and Packaging for NDA: 050615
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CLEOCIN T | clindamycin phosphate | GEL;TOPICAL | 050615 | NDA | Pharmacia and Upjohn Company LLC | 0009-3331 | 0009-3331-01 | 1 TUBE in 1 CARTON (0009-3331-01) > 60 g in 1 TUBE |
| CLEOCIN T | clindamycin phosphate | GEL;TOPICAL | 050615 | NDA | Pharmacia and Upjohn Company LLC | 0009-3331 | 0009-3331-02 | 1 TUBE in 1 CARTON (0009-3331-02) > 30 g in 1 TUBE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | GEL;TOPICAL | Strength | EQ 1% BASE | ||||
| Approval Date: | Jan 7, 1987 | TE: | AB | RLD: | Yes | ||||
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