Details for New Drug Application (NDA): 203513
NDA 203513 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 seven suppliers. Additional details are available on the CLINDAMYCIN PALMITATE HYDROCHLORIDE profile page.
The generic ingredient in CLINDAMYCIN PALMITATE HYDROCHLORIDE is clindamycin palmitate hydrochloride. There is one drug master file entry for this compound. Eight 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 is one drug master file entry for this compound. Eight suppliers are listed for this compound. Additional details are available on the clindamycin palmitate hydrochloride profile page.
Summary for 203513
| Tradename: | CLINDAMYCIN PALMITATE HYDROCHLORIDE |
| Applicant: | Amneal Pharms |
| Ingredient: | clindamycin palmitate hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 203513
| Physiological Effect | Decreased Sebaceous Gland Activity Neuromuscular Blockade |
Suppliers and Packaging for NDA: 203513
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CLINDAMYCIN PALMITATE HYDROCHLORIDE | clindamycin palmitate hydrochloride | FOR SOLUTION;ORAL | 203513 | ANDA | Amneal Pharmaceuticals of New York LLC | 53746-468 | 53746-468-19 | 1 BOTTLE in 1 CARTON (53746-468-19) / 100 mL in 1 BOTTLE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | FOR SOLUTION;ORAL | Strength | EQ 75MG BASE/5ML | ||||
| Approval Date: | Mar 13, 2014 | TE: | RLD: | No | |||||
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