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Details for New Drug Application (NDA): 201821

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NDA 201821 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: 201821

Tradename:
CLINDAMYCIN PALMITATE HYDROCHLORIDE
Applicant:
Lyne
Ingredient:
clindamycin palmitate hydrochloride
Patents:0
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details

Pharmacology for NDA: 201821

Ingredient-typeLincosamides
Physiological EffectDecreased Sebaceous Gland Activity

Suppliers and Packaging for NDA: 201821

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CLINDAMYCIN PALMITATE HYDROCHLORIDE
clindamycin palmitate hydrochloride
FOR SOLUTION;ORAL 201821 ANDA Lyne Laboratories, Inc. 0374-5070 0374-5070-01 100 mL in 1 BOTTLE (0374-5070-01)
CLINDAMYCIN PALMITATE HYDROCHLORIDE
clindamycin palmitate hydrochloride
FOR SOLUTION;ORAL 201821 ANDA Rising Pharmaceuticals, Inc. 64980-511 64980-511-10 100 mL in 1 BOTTLE (64980-511-10)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:FOR SOLUTION;ORALStrengthEQ 75MG BASE/5ML
Approval Date:Aug 28, 2012TE:AARLD:No


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