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Generated: January 22, 2019

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Details for New Drug Application (NDA): 203048

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NDA 203048 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-eight suppliers are listed for this compound. Additional details are available on the clindamycin phosphate profile page.
Summary for 203048
Tradename:CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER
Applicant:Akorn Inc
Ingredient:clindamycin phosphate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 203048
Suppliers and Packaging for NDA: 203048
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 203048 ANDA Akorn, Inc. 17478-120 17478-120-50 1 BOTTLE, GLASS in 1 CARTON (17478-120-50) > 50 mL in 1 BOTTLE, GLASS
CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER clindamycin phosphate INJECTABLE;INJECTION 203048 ANDA Akorn, Inc. 17478-121 17478-121-50 1 BOTTLE, GLASS in 1 CARTON (17478-121-50) > 50 mL in 1 BOTTLE, GLASS

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 6MG BASE/ML
Approval Date:Apr 4, 2013TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 12MG BASE/ML
Approval Date:Apr 4, 2013TE:APRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 18MG BASE/ML
Approval Date:Apr 4, 2013TE:APRLD:No

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