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FDA Approval

Midazolam Hydrochloride

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Precision Dose Inc.
DUNS: 035886746
Effective Date
December 22, 2023
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Midazolam(2 mg in 1 mL)

Products1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Midazolam Hydrochloride

Product Details

NDC Product Code
68094-764
Application Number
ANDA075873
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
December 22, 2023
MidazolamActive
Code: W7TTW573JJClass: ACTIMQuantity: 2 mg in 1 mL
Edetate disodiumInactive
Code: 7FLD91C86KClass: IACT
D&C Red No. 33Inactive
Code: 9DBA0SBB0LClass: IACT
Hydrochloric acidInactive
Code: QTT17582CBClass: IACT
GlycerinInactive
Code: PDC6A3C0OXClass: IACT
sodium benzoateInactive
Code: OJ245FE5EUClass: IACT
sodium citrate, unspecified formInactive
Code: 1Q73Q2JULRClass: IACT
saccharin sodiumInactive
Code: SB8ZUX40TYClass: IACT
sorbitolInactive
Code: 506T60A25RClass: IACT
waterInactive
Code: 059QF0KO0RClass: IACT
Anhydrous citric acidInactive
Code: XF417D3PSLClass: IACT
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