Details for New Drug Application (NDA): 021431
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NDA 021431 describes CAMPRAL, which is a drug marketed by Forest Labs and is included in one NDA. Additional details are available on the CAMPRAL profile page.
The generic ingredient in CAMPRAL is acamprosate calcium. There are eight drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the acamprosate calcium profile page.
The generic ingredient in CAMPRAL is acamprosate calcium. There are eight drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the acamprosate calcium profile page.
Summary for 021431
| Tradename: | CAMPRAL |
| Applicant: | Forest Labs |
| Ingredient: | acamprosate calcium |
| Patents: | 0 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET, DELAYED RELEASE;ORAL | Strength | 333MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Jul 29, 2004 | TE: | RLD: | Yes | |||||
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