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Serving hundreds of leading biopharmaceutical companies globally:

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Generated: March 24, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203513

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NDA 203513 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 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-four 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 203513
Applicant:Amneal Pharms
Ingredient:clindamycin palmitate hydrochloride
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details
Pharmacology for NDA: 203513
Physiological EffectDecreased Sebaceous Gland Activity
Suppliers and Packaging for NDA: 203513
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CLINDAMYCIN PALMITATE HYDROCHLORIDE clindamycin palmitate hydrochloride FOR SOLUTION;ORAL 203513 ANDA Marlex Pharmaceuticals Inc 10135-569 E 10135-569-19
CLINDAMYCIN PALMITATE HYDROCHLORIDE clindamycin palmitate hydrochloride FOR SOLUTION;ORAL 203513 ANDA Amneal Pharmaceuticals LLC 65162-468 N 65162-468-19

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:FOR SOLUTION;ORALStrengthEQ 75MG BASE/5ML
Approval Date:Mar 13, 2014TE:AARLD:No

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