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MIDAZOLAM HYDROCHLORIDE

ANDA

MIDAZOLAM HYDROCHLORIDE | A075247 | HIKMA PHARMACEUTICALS USA INC

2 strengths0 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
Jun 9, 2004	ORIG -1	View Letter (PDF)
Jun 23, 2000	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

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#001 — EQ 5MG BASE/ML

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Jun 23, 2000

No patent or exclusivity listings for this strength.

#002 — EQ 1MG BASE/ML

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Jun 23, 2000