Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Novel Laboratories, Inc.
793518643
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Novel Laboratories, Inc.
Novel Laboratories, Inc.
Novel Laboratories, Inc.
793518643
Products2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Misoprostol
Product Details
NDC Product Code
40032-161Application Number
ANDA091667Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
December 21, 2020CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
HYDROGENATED CASTOR OILInactive
Code: ZF94AP8MEYClass: IACT
CROSPOVIDONEInactive
Code: 2S7830E561Class: IACT
MisoprostolActive
Code: 0E43V0BB57Class: ACTIBQuantity: 200 ug in 1 1
Misoprostol
Product Details
NDC Product Code
40032-160Application Number
ANDA091667Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
December 21, 2020HYDROGENATED CASTOR OILInactive
Code: ZF94AP8MEYClass: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
MisoprostolActive
Code: 0E43V0BB57Class: ACTIBQuantity: 100 ug in 1 1
CROSPOVIDONEInactive
Code: 2S7830E561Class: IACT