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Details for New Drug Application (NDA): 202409

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NDA 202409 describes CLINDAMYCIN PALMITATE HYDROCHLORIDE, which is a drug marketed by Paddock Labs, Aurobindo Pharma Ltd, Amneal Pharms, Lyne, and Mylan Pharms Inc, and is included in five 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-two 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 NDA: 202409

Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details

Pharmacology for NDA: 202409

Physiological EffectDecreased Sebaceous Gland Activity

Suppliers and Packaging for NDA: 202409

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
clindamycin palmitate hydrochloride
FOR SOLUTION;ORAL 202409 ANDA NorthStar Rx LLC 16714-483 16714-483-01 1 BOTTLE in 1 CARTON (16714-483-01) > 100 mL in 1 BOTTLE
clindamycin palmitate hydrochloride
FOR SOLUTION;ORAL 202409 ANDA Aurobindo Pharma Limited 65862-596 65862-596-01 1 BOTTLE in 1 CARTON (65862-596-01) > 100 mL in 1 BOTTLE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:FOR SOLUTION;ORALStrengthEQ 75MG BASE/5ML
Approval Date:Apr 30, 2013TE:AARLD:No

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.