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Generated: November 17, 2018

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Details for New Drug Application (NDA): 208084

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NDA 208084 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 208084
Tradename:CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER
Applicant:Baxter Hlthcare Corp
Ingredient:clindamycin phosphate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 208084
Ingredient-typeLincosamides
Physiological EffectDecreased Sebaceous Gland Activity
Suppliers and Packaging for NDA: 208084
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 208084 ANDA Baxter Healthcare Corporation 0338-3410 0338-3410-24 24 BAG in 1 CARTON (0338-3410-24) > 50 mL in 1 BAG (0338-3410-50)
CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER clindamycin phosphate INJECTABLE;INJECTION 208084 ANDA Baxter Healthcare Corporation 0338-3612 0338-3612-24 24 BAG in 1 CARTON (0338-3612-24) > 50 mL in 1 BAG (0338-3612-50)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 6MG BASE/ML
Approval Date:Jun 28, 2017TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 12MG BASE/ML
Approval Date:Jun 28, 2017TE:APRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 18MG BASE/ML
Approval Date:Jun 28, 2017TE:APRLD:No

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