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Generated: November 17, 2018

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Details for New Drug Application (NDA): 201692

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NDA 201692 describes CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER, which is a drug marketed by Akorn Inc, Baxter Hlthcare Corp, and Sandoz Inc, and is included in three NDAs. It is available from three suppliers. Additional details are available on the CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER profile page.

The generic ingredient in CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER is clindamycin phosphate. There are fifty-five drug master file entries for this compound. Thirty-five suppliers are listed for this compound. Additional details are available on the clindamycin phosphate profile page.
Summary for 201692
Tradename:CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER
Applicant:Sandoz Inc
Ingredient:clindamycin phosphate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 201692
Ingredient-typeLincosamides
Physiological EffectDecreased Sebaceous Gland Activity
Suppliers and Packaging for NDA: 201692
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER clindamycin phosphate INJECTABLE;INJECTION 201692 ANDA Sandoz Inc 0781-3288 0781-3288-09 24 BAG in 1 CARTON (0781-3288-09) > 50 mL in 1 BAG (0781-3288-91)
CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER clindamycin phosphate INJECTABLE;INJECTION 201692 ANDA Sandoz Inc 0781-3289 0781-3289-09 24 BAG in 1 CARTON (0781-3289-09) > 50 mL in 1 BAG (0781-3289-91)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 6MG BASE/ML
Approval Date:May 31, 2012TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 12MG BASE/ML
Approval Date:May 31, 2012TE:APRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 18MG BASE/ML
Approval Date:May 31, 2012TE:APRLD:No

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