Last Updated: September 28, 2026

Details for New Drug Application (NDA): 201821


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NDA 201821 describes CLINDAMYCIN PALMITATE HYDROCHLORIDE, which is a drug marketed by Amneal Pharms, Appco, Aurobindo Pharma Ltd, Chartwell Rx, Extrovis, Padagis Us, and Rising, 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.
Summary for 201821
Tradename:CLINDAMYCIN PALMITATE HYDROCHLORIDE
Applicant:Rising
Ingredient:clindamycin palmitate hydrochloride
Patents:0
Pharmacology for NDA: 201821
Physiological EffectDecreased 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:RXDosage:FOR SOLUTION;ORALStrengthEQ 75MG BASE/5ML
Approval Date:Aug 28, 2012TE:AARLD:No

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2026, www.DrugPatentWatch.com.
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