Details for New Drug Application (NDA): 062644
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NDA 062644 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 fifty-five drug master file entries for this compound. Ten 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 fifty-five drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the clindamycin palmitate hydrochloride profile page.
Summary for 062644
| Tradename: | CLEOCIN |
| Applicant: | Pfizer |
| Ingredient: | clindamycin palmitate hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 062644
| Physiological Effect | Decreased Sebaceous Gland Activity Neuromuscular Blockade |
Suppliers and Packaging for NDA: 062644
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CLEOCIN | clindamycin palmitate hydrochloride | FOR SOLUTION;ORAL | 062644 | ANDA | Pharmacia & Upjohn Company LLC | 0009-0760 | 0009-0760-04 | 1 BOTTLE in 1 CARTON (0009-0760-04) / 100 mL in 1 BOTTLE |
| CLEOCIN | clindamycin palmitate hydrochloride | FOR SOLUTION;ORAL | 062644 | ANDA | Greenstone LLC | 59762-0016 | 59762-0016-1 | 1 BOTTLE in 1 CARTON (59762-0016-1) / 100 mL in 1 BOTTLE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | FOR SOLUTION;ORAL | Strength | EQ 75MG BASE/5ML | ||||
| Approval Date: | Apr 7, 1986 | TE: | AA | RLD: | No | ||||
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