Details for New Drug Application (NDA): 201821
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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 201821
Tradename: | CLINDAMYCIN PALMITATE HYDROCHLORIDE |
Applicant: | Rising |
Ingredient: | clindamycin palmitate hydrochloride |
Patents: | 0 |
Pharmacology for NDA: 201821
Physiological Effect | Decreased Sebaceous Gland Activity Neuromuscular Blockade |
Suppliers and Packaging for NDA: 201821
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
CLINDAMYCIN PALMITATE HYDROCHLORIDE | clindamycin palmitate hydrochloride | FOR SOLUTION;ORAL | 201821 | ANDA | Bryant Ranch Prepack | 63629-2391 | 63629-2391-1 | 100 mL in 1 BOTTLE (63629-2391-1) |
CLINDAMYCIN PALMITATE HYDROCHLORIDE | clindamycin palmitate hydrochloride | FOR SOLUTION;ORAL | 201821 | ANDA | Rising Pharma Holdings, Inc. | 64980-511 | 64980-511-10 | 100 mL in 1 BOTTLE (64980-511-10) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | FOR SOLUTION;ORAL | Strength | EQ 75MG BASE/5ML | ||||
Approval Date: | Aug 28, 2012 | TE: | AA | RLD: | No |
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