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ZIBA-RX

ANDA

BACITRACIN ZINC | A061737 | X GEN PHARMACEUTICALS INC

1 strength0 unique patents0 unique exclusivities

Citizen Petitions

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Akorn Animal Health Inc. FDA-2020-P-1074 · 8 docket documents Akorn Animal Health Inc. filed this petition under section 512(n)(3) of the Federal Food, Drug, and Cosmetic Act requesting FDA permission to pursue approval of an Abbreviated New Animal Drug Application for Neomycin and Polymixin B Sulfates, Bacitracin Zinc, and Hydrocortisone Ophthalmic Ointment,	Other	2020-03-12	Granted	Akorn Animal Health Inc.

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

API Supply Chain3 active DMFs5 inactive

3 active API suppliers hold Drug Master Files for this ingredient.

ALP PHARM BEIJING CO LTDBACITRACIN ZINC

DMF 240002010

JOYANG LABORATORIESBACITRACIN ZINC

DMF 277332013

XELLIA PHARMACEUTICALS APSBACITRACIN ZINC, STERILE

DMF 283552014

SIGMA F AND D DIV LTDInactiveBACITRACIN ZINC

DMF 38581980

ALPHAPHARM PARTY LTDInactiveBACITRACIN ZINC

DMF 133441998

DUMEX LTDInactiveBACITRACIN ZINC

DMF 135681998

WORLD JIANGSU INDUSTRY CO LTDInactiveBACITRACIN ZINC USP (NON-STERILE DRUG SUBSTANCE)

DMF 191332006

JOYANG LABORATORIESInactiveBACITRACIN ZINC

DMF 250952011

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

Products (1)

#001 — 500,000 UNITS/BOT

0 patents0 exclusivities▴

POWDER;FOR RX COMPOUNDING | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.