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Details for New Drug Application (NDA): 050141

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NDA 050141 describes BICILLIN L-A, which is a drug marketed by Wyeth Ayerst and King Pharms and is included in two NDAs. It is available from two suppliers. Additional details are available on the BICILLIN L-A profile page.

The generic ingredient in BICILLIN L-A is penicillin g benzathine. There are eighty-seven drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the penicillin g benzathine profile page.

Summary for NDA: 050141

Tradename:
BICILLIN L-A
Applicant:
King Pharms
Ingredient:
penicillin g benzathine
Patents:0
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details

Pharmacology for NDA: 050141

Ingredient-typePenicillins

Suppliers and Packaging for NDA: 050141

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BICILLIN L-A
penicillin g benzathine
INJECTABLE;INJECTION 050141 NDA A-S Medication Solutions LLC 54569-5877 54569-5877-1 10 SYRINGE in 1 PACKAGE (54569-5877-1) > 2 mL in 1 SYRINGE
BICILLIN L-A
penicillin g benzathine
INJECTABLE;INJECTION 050141 NDA Pfizer Laboratories Div Pfizer Inc 60793-700 60793-700-10 10 SYRINGE in 1 PACKAGE (60793-700-10) > 1 mL in 1 SYRINGE (60793-700-01)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength600,000 UNITS/ML
Approval Date:Approved Prior to Jan 1, 1982TE:BCRLD:Yes

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength300,000 UNITS/ML
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:Yes


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