Details for New Drug Application (NDA): 090902
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NDA 090902 describes CLINDAMYCIN PALMITATE HYDROCHLORIDE, which is a drug marketed by Amneal Pharms, Aurobindo Pharma Ltd, Chartwell Rx, Extrovis, Padagis Us, Rising, and Somerset Theraps Llc, and is included in seven NDAs. It is available from eight suppliers. Additional details are available on the CLINDAMYCIN PALMITATE HYDROCHLORIDE profile page.
The generic ingredient in CLINDAMYCIN PALMITATE HYDROCHLORIDE is clindamycin palmitate hydrochloride. There are fifty-five 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 CLINDAMYCIN PALMITATE HYDROCHLORIDE is clindamycin palmitate hydrochloride. There are fifty-five 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 090902
| Tradename: | CLINDAMYCIN PALMITATE HYDROCHLORIDE |
| Applicant: | Padagis Us |
| Ingredient: | clindamycin palmitate hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 090902
| Physiological Effect | Decreased Sebaceous Gland Activity Neuromuscular Blockade |
Suppliers and Packaging for NDA: 090902
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CLINDAMYCIN PALMITATE HYDROCHLORIDE | clindamycin palmitate hydrochloride | FOR SOLUTION;ORAL | 090902 | ANDA | Bryant Ranch Prepack | 63629-2523 | 63629-2523-1 | 1 BOTTLE, GLASS in 1 CARTON (63629-2523-1) / 100 mL in 1 BOTTLE, GLASS |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | FOR SOLUTION;ORAL | Strength | EQ 75MG BASE/5ML | ||||
| Approval Date: | Jul 7, 2010 | TE: | RLD: | No | |||||
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