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Serving leading biopharmaceutical companies globally:

Express Scripts
Johnson and Johnson
Fish and Richardson

Generated: December 17, 2017

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-three 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

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 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

Summary 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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Serving leading biopharmaceutical companies globally:

Queensland Health
Argus Health
Boehringer Ingelheim

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