Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
AVET LIFESCIENCES PRIVATE LIMITED
853181664
Manufacturing Establishments2
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
RA CHEM PHARMA LIMITED
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
AVET LIFESCIENCES PRIVATE LIMITED
677637710
CorePharma, LLC
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
AVET LIFESCIENCES PRIVATE LIMITED
031192276
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
23155-149Application Number
ANDA202271Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
March 24, 2022STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
AcarboseActive
Code: T58MSI464GClass: ACTIBQuantity: 100 mg in 1 1
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
Acarbose
Product Details
NDC Product Code
23155-148Application Number
ANDA202271Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
March 24, 2022AcarboseActive
Code: T58MSI464GClass: ACTIBQuantity: 50 mg in 1 1
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
Acarbose
Product Details
NDC Product Code
23155-147Application Number
ANDA202271Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
March 24, 2022MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
AcarboseActive
Code: T58MSI464GClass: ACTIBQuantity: 25 mg in 1 1
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT