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MIDAZOLAM IN 0.9% SODIUM CHLORIDE

ANDA

MIDAZOLAM | A216159 | HIKMA PHARMACEUTICALS USA INC

2 strengths0 unique patents0 unique exclusivities

Reference Listed Drug: MIDAZOLAM IN 0.9% SODIUM CHLORIDE(TE code: AP)

API Supply Chain8 active DMFs4 inactive

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

WAVELENGTH ENTERPRISES LTDMIDAZOLAM

DMF 125531997

CAMBREX PROFARMACO MILANO SRLMIDAZOLAM

DMF 126861997

FIS FABBRICA ITALIANA SINTETICI SPAMIDAZOLAM HCI

DMF 252042011

COHANCE LIFESCIENCES LTDMIDAZOLAM USP

DMF 268712013

SOLARA ACTIVE PHARMA SCIENCES LTDMIDAZOLAM

DMF 298812015

CAMBREX PROFARMACO MILANO SRLMIDAZOLAM MALEATE

DMF 371022022

GLOBAL CALCIUM PRIVATE LTDMIDAZOLAM USP

DMF 393652024

SUPRIYA LIFESCIENCE LTDMIDAZOLAM USP

DMF 432712025

ABBOTT LABORATORIES HOSP PRODUCTS DIVInactiveMIDAZOLAM

DMF 127451997

DIOSYNTH BVInactiveMIDAZOLAM

DMF 129101998

PCASInactiveMIDAZOLAM BASE

DMF 129291998

SUN PHARMACEUTICAL INDUSTRIES LTDInactiveMIDAZOLAM (NON-STERILE BULK) USP

DMF 151702000

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
May 2, 2023	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

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#001 — 50MG/50ML (1MG/ML)

0 patents0 exclusivities▴

SOLUTION;INTRAVENOUS | Approved: Apr 17, 2023

No patent or exclusivity listings for this strength.

#002 — 100MG/100ML (1MG/ML)

0 patents0 exclusivities▾

SOLUTION;INTRAVENOUS | Approved: Apr 17, 2023