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MIDAZOLAM HYDROCHLORIDE

ANDA

MIDAZOLAM HYDROCHLORIDE | A076058 | SUN PHARMACEUTICAL INDUSTRIES LTD

1 strength0 unique patents0 unique exclusivities

API Supply Chain1 active DMF

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

CAMBREX PROFARMACO MILANO SRLMIDAZOLAM HYDROCHLORIDE

DMF 399912024

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

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Apr 16, 2003	ORIG -1	View Letter (PDF)
Apr 10, 2003	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 2MG BASE/ML

0 patents0 exclusivities▴

SYRUP;ORAL | Approved: Mar 15, 2002

No patent or exclusivity listings for this strength.