Misoprostol
Misoprostol Tablets GAVIS Pharmaceuticals, LLC
Approved
Approval ID
4974780a-ca09-4c1e-b593-bfe17ca08480
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 15, 2014
Manufacturers
FDA
Aidarex Pharmaceuticals LLC
DUNS: 801503249
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Misoprostol
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code33261-076
Application NumberANDA091667
Product Classification
M
Marketing Category
C73584
G
Generic Name
Misoprostol
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 15, 2014
FDA Product Classification
INGREDIENTS (4)
MISOPROSTOLActive
Quantity: 200 ug in 1 1
Code: 0E43V0BB57
Classification: ACTIB
HYDROGENATED CASTOR OILInactive
Code: ZF94AP8MEY
Classification: IACT
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
Misoprostol
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code33261-754
Application NumberANDA091667
Product Classification
M
Marketing Category
C73584
G
Generic Name
Misoprostol
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 15, 2014
FDA Product Classification
INGREDIENTS (4)
MISOPROSTOLActive
Quantity: 100 ug in 1 1
Code: 0E43V0BB57
Classification: ACTIB
HYDROGENATED CASTOR OILInactive
Code: ZF94AP8MEY
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT