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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 Paddock Labs, Aurobindo Pharma Ltd, Amneal Pharms, Lyne, and Mylan Pharms Inc, and is included in five NDAs. It is available from nine 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-two drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the clindamycin palmitate hydrochloride profile page.

Summary for NDA: 090902

Paddock Labs
clindamycin palmitate hydrochloride
Therapeutic Class:Antibacterials

Pharmacology for NDA: 090902

Physiological EffectDecreased Sebaceous Gland Activity

Suppliers and Packaging for NDA: 090902

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
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
clindamycin palmitate hydrochloride
FOR SOLUTION;ORAL 090902 ANDA REMEDYREPACK INC. 61786-664 61786-664-20 100 mL in 1 BOTTLE, GLASS (61786-664-20)

Summary 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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