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Generated: May 26, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203063

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NDA 203063 describes CLINDAMYCIN PALMITATE HYDROCHLORIDE, which is a drug marketed by Amneal Pharms, Appco Pharma Llc, Aurobindo Pharma Ltd, Lyne, Mylan Pharms Inc, Orit Labs Llc, and Paddock Llc, and is included in seven 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-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 203063
Tradename:CLINDAMYCIN PALMITATE HYDROCHLORIDE
Applicant:Mylan Pharms Inc
Ingredient:clindamycin palmitate hydrochloride
Patents:0
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details
Pharmacology for NDA: 203063
Ingredient-typeLincosamides
Physiological EffectDecreased Sebaceous Gland Activity
Suppliers and Packaging for NDA: 203063
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CLINDAMYCIN PALMITATE HYDROCHLORIDE clindamycin palmitate hydrochloride FOR SOLUTION;ORAL 203063 ANDA Mylan Pharmaceuticals Inc. 0378-8730 N 0378-8730-35

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:FOR SOLUTION;ORALStrengthEQ 75MG BASE/5ML
Approval Date:May 25, 2016TE:AARLD:No

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