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Details for New Drug Application (NDA): 060657

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NDA 060657 describes PFIZERPEN, which is a drug marketed by Pfizer and is included in eight NDAs. It is available from one supplier. Additional details are available on the PFIZERPEN profile page.

The generic ingredient in PFIZERPEN is penicillin g procaine. There are eighty-seven drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the penicillin g procaine profile page.

Summary for NDA: 060657

Tradename:
PFIZERPEN
Applicant:
Pfizer
Ingredient:
penicillin g potassium
Patents:0
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details

Pharmacology for NDA: 060657

Ingredient-typePenicillins

Suppliers and Packaging for NDA: 060657

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PFIZERPEN
penicillin g potassium
INJECTABLE;INJECTION 060657 ANDA Roerig 0049-0520 0049-0520-83 10 VIAL in 1 CARTON (0049-0520-83) > 1 POWDER, FOR SOLUTION in 1 VIAL (0049-0520-84)
PFIZERPEN
penicillin g potassium
INJECTABLE;INJECTION 060657 ANDA Roerig 0049-0520 0049-0520-22 10 VIAL in 1 CARTON (0049-0520-22) > 1 POWDER, FOR SOLUTION in 1 VIAL

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength1,000,000 UNITS/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength5,000,000 UNITS/VIAL
Approval Date:Approved Prior to Jan 1, 1982TE:APRLD:Yes

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength20,000,000 UNITS/VIAL
Approval Date:Approved Prior to Jan 1, 1982TE:APRLD:Yes


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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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