Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Carilion Materials Management
079239644
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Carilion Materials Management
Carilion Materials Management
Carilion Materials Management
079239644
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Campral
Product Details
NDC Product Code
68151-4760Application Number
NDA021431Marketing Category
NDA (C73594)Route of Administration
ORALEffective Date
January 31, 2012AcamprosateActive
Code: 59375N1D0UClass: ACTIBQuantity: 333 mg in 1 1
CROSPOVIDONEInactive
Code: 68401960MKClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
MAGNESIUM SILICATEInactive
Code: 9B9691B2N9Class: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AInactive
Code: NX76LV5T8JClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT