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UNIPEN

ANDA

NAFCILLIN SODIUM | A062717 | WYETH AYERST LABORATORIES

3 strengths0 unique patents0 unique exclusivities

API Supply Chain3 active DMFs4 inactive

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

ACS DOBFAR SPANAFCILLIN SODIUM FOR INJECTION (BULK)

DMF 136951998

APITORIA PHARMA PRIVATE LTDNAFCILLIN SODIUM (NON-STERILE DRUG SUBSTANCE INTERMEDIATE)

DMF 224732009

ACS DOBFAR SPANAFCILLIN SODIUM FOR INJECTION (STERILE BULK)

DMF 273132013

FERMENTA PRODUCTS INCInactiveNAFCILLIN SODIUM

DMF 133871998

SMITHKLINE BEECHAM PHARMACEUTICALSInactiveNAFCILLIN SODIUM

DMF 135541998

LATINA PHARMA SPAInactiveNAFCILLIN SODIUM STERILE

DMF 136531998

ACS DOBFAR SPAInactiveNAFCILLIN SODIUM

DMF 136971998

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

Products (3)

Sort:

#001 — EQ 500MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Dec 16, 1986

No patent or exclusivity listings for this strength.

#002 — EQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Dec 16, 1986

#004 — EQ 2GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Dec 16, 1986