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Serving 500+ biopharmaceutical companies globally:

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Generated: June 25, 2017

DrugPatentWatch Database Preview

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 and Sandoz Inc and is included in two NDAs. It is available from two 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-two drug master file entries for this compound. Thirty-three suppliers are listed for this compound. Additional details are available on the clindamycin phosphate profile page.

Summary for NDA: 203048

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:1
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details

Pharmacology for NDA: 203048

Ingredient-typeLincosamides
Physiological EffectDecreased Sebaceous Gland Activity

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

Summary for product number 001

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

Summary for product number 002

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

Summary 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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Serving 500+ biopharmaceutical companies globally:

Federal Trade Commission
Queensland Health
Mallinckrodt
Colorcon
Chubb
Daiichi Sankyo
Farmers Insurance
US Department of Justice
Cerilliant
Harvard Business School

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