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Generated: January 16, 2019

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Details for New Drug Application (NDA): 090902

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NDA 090902 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 090902
Applicant:Paddock Llc
Ingredient:clindamycin palmitate hydrochloride
Formulation / Manufacturing:see details
Pharmacology for NDA: 090902
Suppliers and Packaging for NDA: 090902
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CLINDAMYCIN PALMITATE HYDROCHLORIDE clindamycin palmitate hydrochloride FOR SOLUTION;ORAL 090902 ANDA Paddock Laboratories, LLC 0574-0129 0574-0129-01 1 BOTTLE, GLASS in 1 CARTON (0574-0129-01) > 100 mL in 1 BOTTLE, GLASS

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:FOR SOLUTION;ORALStrengthEQ 75MG BASE/5ML
Approval Date:Jul 7, 2010TE:AARLD:No

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