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
NDC Product Code70954-480
Application NumberANDA074826
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateNovember 23, 2022
Generic NameEstazolam
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
NDC Product Code70954-481
Application NumberANDA074826
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateNovember 23, 2022
Generic NameEstazolam
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