Details for New Drug Application (NDA): 050600
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NDA 050600 describes CLEOCIN T, which is a drug marketed by Pfizer and 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-six 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-six suppliers are listed for this compound. Additional details are available on the clindamycin phosphate profile page.
Summary for 050600
| Tradename: | CLEOCIN T |
| Applicant: | Pfizer |
| Ingredient: | clindamycin phosphate |
| Patents: | 0 |
Pharmacology for NDA: 050600
| Physiological Effect | Decreased Sebaceous Gland Activity Neuromuscular Blockade |
Suppliers and Packaging for NDA: 050600
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CLEOCIN T | clindamycin phosphate | LOTION;TOPICAL | 050600 | NDA | Pharmacia & Upjohn Company LLC | 0009-3329 | 0009-3329-01 | 1 BOTTLE in 1 CARTON (0009-3329-01) / 60 mL in 1 BOTTLE |
| CLEOCIN T | clindamycin phosphate | LOTION;TOPICAL | 050600 | NDA AUTHORIZED GENERIC | Mylan Pharmaceuticals Inc. | 59762-3744 | 59762-3744-1 | 1 BOTTLE in 1 CARTON (59762-3744-1) / 60 mL in 1 BOTTLE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | LOTION;TOPICAL | Strength | EQ 1% BASE | ||||
| Approval Date: | May 31, 1989 | TE: | AB | RLD: | Yes | ||||
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