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NEO-FRADIN

ANDA

NEOMYCIN SULFATE | A065010 | X GEN PHARMACEUTICALS INC

1 strength0 unique patents0 unique exclusivities

API Supply Chain3 active DMFs10 inactive

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

PHARMACIA AND UPJOHN CO WHOLLY OWNED SUB PFIZER INCNEOMYCIN SULFATE USP

DMF 133781998

HUASHU PHARMACEUTICAL CORPNEOMYCIN SULFATE

DMF 173822004

YICHANG SANXIA PHARMACEUTICAL CO LTDNEOMYCIN SULFATE AND NEOMYCIN SULFATE MICRONIZED

DMF 320912017

SB PENICK AND COInactiveNEOMYCIN SULFATE USP

DMF 1101953

PFIZER INCInactiveNEOMYCIN SULFATE CAPS (THIS DMF CHANGED TO NDA 9-579)

DMF 1241953

APOTHEKERNES LABORATORIUM ASInactiveNEOMYCIN SULFATE

DMF 2421940

UPJOHN COInactiveNEOMYCIN SULFATE 0.5GM, COMMERICIAL GRADE, NOT USP

DMF 2621940

CHAS PFIZER AND CO INCInactiveNEOMYCIN SULFATE (VET MED)

DMF 2701940

MERCK AND CO INCInactiveNEOMYCIN SULFATE

DMF 2711940

PENICK CORPInactiveNEOMYCIN SULFATE

DMF 132861998

APOTHEKERNES LABORATORIUM ASInactiveNEOMYCIN SULFATE

DMF 135281998

APOTHEKERNES LABORATORIUM ASInactiveNEOMYCIN SULFATE

DMF 136091998

ROUSSELL UCLAFInactiveNEOMYCIN SULFATE

DMF 136151998

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Apr 9, 2003	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 87.5MG BASE/5ML

0 patents0 exclusivities▴

SOLUTION;ORAL | Approved: May 23, 2002

No patent or exclusivity listings for this strength.