Details for New Drug Application (NDA): 090902
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The generic ingredient in CLINDAMYCIN PALMITATE HYDROCHLORIDE 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 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 | Padagis US LLC | 0574-0129 | 0574-0129-01 | 1 BOTTLE, GLASS in 1 CARTON (0574-0129-01) / 100 mL in 1 BOTTLE, GLASS |
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: | RX | Dosage: | FOR SOLUTION;ORAL | Strength | EQ 75MG BASE/5ML | ||||
Approval Date: | Jul 7, 2010 | TE: | AA | RLD: | No |
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