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Generated: November 18, 2018

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Details for New Drug Application (NDA): 050638

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NDA 050638 describes PENICILLIN G POTASSIUM IN PLASTIC CONTAINER, which is a drug marketed by Baxter Hlthcare and is included in one NDA. It is available from one supplier. Additional details are available on the PENICILLIN G POTASSIUM IN PLASTIC CONTAINER profile page.

The generic ingredient in PENICILLIN G POTASSIUM IN PLASTIC CONTAINER is penicillin g potassium. There are ninety-two drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the penicillin g potassium profile page.
Summary for 050638
Tradename:PENICILLIN G POTASSIUM IN PLASTIC CONTAINER
Applicant:Baxter Hlthcare
Ingredient:penicillin g potassium
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 050638
Ingredient-typePenicillins
Suppliers and Packaging for NDA: 050638
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PENICILLIN G POTASSIUM IN PLASTIC CONTAINER penicillin g potassium INJECTABLE;INJECTION 050638 NDA Baxter Healthcare Corporation 0338-1021 0338-1021-41 50 mL in 1 BAG (0338-1021-41)
PENICILLIN G POTASSIUM IN PLASTIC CONTAINER penicillin g potassium INJECTABLE;INJECTION 050638 NDA Baxter Healthcare Corporation 0338-1023 0338-1023-41 50 mL in 1 BAG (0338-1023-41)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength20,000 UNITS/ML
Approval Date:Jun 25, 1990TE:RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength40,000 UNITS/ML
Approval Date:Jun 25, 1990TE:RLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength60,000 UNITS/ML
Approval Date:Jun 25, 1990TE:RLD:Yes

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