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Generated: December 13, 2018

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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, Heritage Pharms Inc, 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 203513
Tradename:CLINDAMYCIN PALMITATE HYDROCHLORIDE
Applicant:Amneal Pharms
Ingredient:clindamycin palmitate hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 203513
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 10135-569-19 1 BOTTLE in 1 BOX (10135-569-19) > 100 mL in 1 BOTTLE
CLINDAMYCIN PALMITATE HYDROCHLORIDE clindamycin palmitate hydrochloride FOR SOLUTION;ORAL 203513 ANDA Amneal Pharmaceuticals LLC 65162-468 65162-468-19 1 BOTTLE in 1 CARTON (65162-468-19) > 100 mL in 1 BOTTLE

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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