Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Strides Pharma Global Pte. Ltd.
659220961
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Strides Pharma Science Limited
Strides Pharma Science Limited
Strides Pharma Global Pte. Ltd.
918513263
Products3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Acarbose
Product Details
NDC Product Code
64380-760Application Number
ANDA090912Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
July 27, 2022CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
AcarboseActive
Code: T58MSI464GClass: ACTIBQuantity: 100 mg in 1 1
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
Acarbose
Product Details
NDC Product Code
64380-758Application Number
ANDA090912Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
July 27, 2022AcarboseActive
Code: T58MSI464GClass: ACTIBQuantity: 25 mg in 1 1
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
Acarbose
Product Details
NDC Product Code
64380-759Application Number
ANDA090912Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
July 27, 2022STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
AcarboseActive
Code: T58MSI464GClass: ACTIBQuantity: 50 mg in 1 1
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT