Estazolam
ESTAZOLAM TABLETS, USP CIV Rx only
Approved
Approval ID
e1c77eb1-9cba-4e89-a03f-9fb797add4f0
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 11, 2022
Manufacturers
FDA
Novitium Pharma LLC
DUNS: 080301870
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 Code70954-480
Application NumberANDA074826
Product Classification
M
Marketing Category
C73584
G
Generic Name
Estazolam
Product Specifications
Route of AdministrationORAL
Effective DateNovember 23, 2022
FDA Product Classification
INGREDIENTS (6)
ESTAZOLAMActive
Quantity: 1 mg in 1 1
Code: 36S3EQV54C
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
Estazolam
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70954-481
Application NumberANDA074826
Product Classification
M
Marketing Category
C73584
G
Generic Name
Estazolam
Product Specifications
Route of AdministrationORAL
Effective DateNovember 23, 2022
FDA Product Classification
INGREDIENTS (8)
ESTAZOLAMActive
Quantity: 2 mg in 1 1
Code: 36S3EQV54C
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT