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FDA Approval

Acamprosate Calcium

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Major Pharmaceuticals
DUNS: 191427277
Effective Date
January 31, 2022
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Acamprosate(333 mg in 1 1)

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
0904-7213
Application Number
ANDA202229
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
January 31, 2022
crospovidoneInactive
Code: 2S7830E561Class: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
Code: 59375N1D0UClass: ACTIBQuantity: 333 mg in 1 1
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AInactive
Code: NX76LV5T8JClass: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
MAGNESIUM SILICATEInactive
Code: 9B9691B2N9Class: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94EClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
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