Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Glenmark Pharmaceuticals Limited
Glenmark Pharmaceuticals Inc., USA
677318665
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Acamprosate Calcium
Product Details
NDC Product Code
68462-435Application Number
ANDA202229Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
April 30, 2020MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94EClass: IACT
MAGNESIUM SILICATEInactive
Code: 9B9691B2N9Class: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
CROSPOVIDONEInactive
Code: 2S7830E561Class: IACT
AcamprosateActive
Code: 59375N1D0UClass: ACTIBQuantity: 333 mg in 1 1
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMERInactive
Code: NX76LV5T8JClass: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT