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MIDAZOLAM HYDROCHLORIDE

ANDA

MIDAZOLAM HYDROCHLORIDE | A075293 | HOSPIRA INC

2 strengths0 unique patents0 unique exclusivities

Citizen Petitions

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Alaunus Pharmaceutical, LLC - Citizen Petition FDA-2010-P-0460 · 4 docket documents Alaunus Pharmaceutical, LLC filed this ANDA suitability petition under Section 505(j)(2)(C) requesting FDA permission to submit an Abbreviated New Drug Application for Midazolam Hydrochloride Injection in a 500 mg/100 mL fliptop vial, which differs from the reference listed drug only in total dosage	Other	2010-09-27	Granted	—

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

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 20, 2000	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

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#001 — EQ 1MG BASE/ML

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Jun 20, 2000

No patent or exclusivity listings for this strength.

#002 — EQ 5MG BASE/ML

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Jun 20, 2000