Estazolam
Estazolam Tablets, USP C-IV Rx only
Approved
Approval ID
a1e3b4bf-22e9-430a-a768-4d86ae886c9e
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 14, 2022
Manufacturers
FDA
Actavis Pharma, Inc.
DUNS: 119723554
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Estazolam
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0591-0745
Application NumberANDA074818
Product Classification
M
Marketing Category
C73584
G
Generic Name
Estazolam
Product Specifications
Route of AdministrationORAL
Effective DateNovember 14, 2022
FDA Product Classification
INGREDIENTS (9)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
ESTAZOLAMActive
Quantity: 2 mg in 1 1
Code: 36S3EQV54C
Classification: ACTIB
DOCUSATE SODIUMInactive
Code: F05Q2T2JA0
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
Estazolam
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0591-0744
Application NumberANDA074818
Product Classification
M
Marketing Category
C73584
G
Generic Name
Estazolam
Product Specifications
Route of AdministrationORAL
Effective DateNovember 14, 2022
FDA Product Classification
INGREDIENTS (8)
ESTAZOLAMActive
Quantity: 1 mg in 1 1
Code: 36S3EQV54C
Classification: ACTIB
DOCUSATE SODIUMInactive
Code: F05Q2T2JA0
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT