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BLEOMYCIN SULFATE

ANDA

BLEOMYCIN SULFATE | A065042 | HIKMA PHARMACEUTICALS USA INC

2 strengths0 unique patents0 unique exclusivities

API Supply Chain3 active DMFs2 inactive

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

TAPI NL BVBLEOMYCIN SULFATE

DMF 137841998

ZHEJIANG HISUN PHARMACEUTICAL CO LTDBLEOMYCIN SULFATE USP (PROCESS II)

DMF 263122012

HUBEI HONCH PHARMACEUTICAL CO LTDBLEOMYCIN SULFATE

DMF 426292025

ZHEJIANG HISUN PHARMACEUTICAL CO LTDInactiveBLEOMYCIN SULFATE USP

DMF 129621998

MAYNE PHARMA USA INCInactiveBLEOMYCIN SULFATE

DMF 132541998

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 10, 2003	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

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#001 — EQ 30 UNITS BASE/VIAL

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Oct 17, 2001

No patent or exclusivity listings for this strength.

#002 — EQ 15 UNITS BASE/VIAL

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Oct 17, 2001