Details for New Drug Application (NDA): 050680
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NDA 050680 describes CLEOCIN, which is a drug marketed by Pharmacia And Upjohn and Pfizer and is included in fourteen NDAs. It is available from two suppliers. Additional details are available on the CLEOCIN profile page.
The generic ingredient in CLEOCIN is clindamycin palmitate hydrochloride. There are three drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the clindamycin palmitate hydrochloride profile page.
The generic ingredient in CLEOCIN is clindamycin palmitate hydrochloride. There are three drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the clindamycin palmitate hydrochloride profile page.
Summary for 050680
| Tradename: | CLEOCIN |
| Applicant: | Pfizer |
| Ingredient: | clindamycin phosphate |
| Patents: | 0 |
Pharmacology for NDA: 050680
| Physiological Effect | Decreased Sebaceous Gland Activity Neuromuscular Blockade |
Suppliers and Packaging for NDA: 050680
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CLEOCIN | clindamycin phosphate | CREAM;VAGINAL | 050680 | NDA | Pharmacia & Upjohn Company LLC | 0009-3448 | 0009-3448-01 | 1 TUBE, WITH APPLICATOR in 1 CARTON (0009-3448-01) / 40 g in 1 TUBE, WITH APPLICATOR |
| CLEOCIN | clindamycin phosphate | CREAM;VAGINAL | 050680 | NDA AUTHORIZED GENERIC | Mylan Pharmaceuticals Inc. | 59762-5009 | 59762-5009-1 | 1 TUBE in 1 CARTON (59762-5009-1) / 40 g in 1 TUBE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | CREAM;VAGINAL | Strength | EQ 2% BASE | ||||
| Approval Date: | Aug 11, 1992 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | CREAM;VAGINAL | Strength | EQ 2% BASE | ||||
| Approval Date: | Mar 2, 1998 | TE: | AB | RLD: | Yes | ||||
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