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Generated: April 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 202409

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NDA 202409 describes CLINDAMYCIN PALMITATE HYDROCHLORIDE, which is a drug marketed by Amneal Pharms, Aurobindo Pharma Ltd, Lyne, Mylan Pharms Inc, Orit Labs Llc, and Paddock Llc, and is included in six 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 are fifty-five drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the clindamycin palmitate hydrochloride profile page.
Summary for 202409
Tradename:CLINDAMYCIN PALMITATE HYDROCHLORIDE
Applicant:Aurobindo Pharma Ltd
Ingredient:clindamycin palmitate hydrochloride
Patents:0
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details
Pharmacology for NDA: 202409
Ingredient-typeLincosamides
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 clindamycin palmitate hydrochloride FOR SOLUTION;ORAL 202409 ANDA NorthStar Rx LLC 16714-483 N 16714-483-01
CLINDAMYCIN PALMITATE HYDROCHLORIDE clindamycin palmitate hydrochloride FOR SOLUTION;ORAL 202409 ANDA Aurobindo Pharma Limited 65862-596 N 65862-596-01

Profile 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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