Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Atlantic Biologicals Corps
047437707
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Atlantic Biologicals Corps
Atlantic Biologicals Corps
Atlantic Biologicals Corps
047437707
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
17856-0205Application Number
ANDA076058Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
October 19, 2009MidazolamActive
Code: W7TTW573JJClass: ACTIBQuantity: 2 mg in 1 mL
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QPClass: IACT
CHERRYInactive
Code: BUC5I9595WClass: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86KClass: IACT
GLYCERINInactive
Code: PDC6A3C0OXClass: IACT
SODIUM CITRATEInactive
Code: 1Q73Q2JULRClass: IACT
D&C RED NO. 33Inactive
Code: 9DBA0SBB0LClass: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EUClass: IACT
SACCHARIN SODIUM DIHYDRATEInactive
Code: SB8ZUX40TYClass: IACT
SORBITOLInactive
Code: 506T60A25RClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT