Midazolam Hydrochloride
MIDAZOLAM HYDROCHLORIDE SYRUP
Approved
Approval ID
20b0cdfa-e2ed-4df3-9ea8-00cc05319bfa
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 19, 2009
Manufacturers
FDA
Atlantic Biologicals Corps
DUNS: 047437707
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Midazolam Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code17856-0205
Application NumberANDA076058
Product Classification
M
Marketing Category
C73584
G
Generic Name
Midazolam Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateOctober 19, 2009
FDA Product Classification
INGREDIENTS (11)
MIDAZOLAM HYDROCHLORIDEActive
Quantity: 2 mg in 1 mL
Code: W7TTW573JJ
Classification: ACTIB
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
CHERRYInactive
Code: BUC5I9595W
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
SODIUM CITRATEInactive
Code: 1Q73Q2JULR
Classification: IACT
D&C RED NO. 33Inactive
Code: 9DBA0SBB0L
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
SACCHARIN SODIUM DIHYDRATEInactive
Code: SB8ZUX40TY
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT