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PENICILLIN G SODIUM

ANDA

PENICILLIN G SODIUM | A061051 | JOHN D COPANOS AND CO INC

1 strength0 unique patents0 unique exclusivities

Citizen Petitions

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Clinical and Laboratory Standards Institute FDA-2007-P-0299 The Clinical and Laboratory Standards Institute filed this citizen petition requesting that the FDA Center for Drug Evaluation and Research update the official drug labels for penicillin G potassium and penicillin G sodium for injection to include newly established nonmeningitis susceptibility break	Other	2008-05-22	Denied	Clinical and Laboratory Standards Institute

Source: Regulations.gov. FDA citizen petitions matched by application number.

API Supply Chain2 active DMFs5 inactive

2 active API suppliers hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

SANDOZ GMBHPENICILLIN G SODIUM (STERILE)

DMF 137511998

FRESENIUS KABI IPSUM SRLPENICILLIN G SODIUM STERILE

DMF 322992017

HOECHST AGInactivePENICILLIN G SODIUM (BULK)

DMF 61381985

GIST-BROCADES NV PHARMACEUTICALSInactivePENICILLIN G SODIUM

DMF 133541998

SQUIBBInactivePENICILLIN G SODIUM

DMF 135371998

PFIZER INCInactivePENICILLIN G SODIUM

DMF 135781998

SANDOZ GMBHInactivePENICILLIN G SODIUM BUFFERED (STERILE)

DMF 137681998

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Products (1)

#001 — 5,000,000 UNITS/VIAL

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.