Details for New Drug Application (NDA): 200142
NDA 200142 describes ACAMPROSATE CALCIUM, which is a drug marketed by Barr Labs Div Teva, Bionpharma, Glenmark Pharms Ltd, Mylan, Somerset Theraps Llc, and Zydus Pharms, and is included in six NDAs. It is available from eleven suppliers. Additional details are available on the ACAMPROSATE CALCIUM profile page.
The generic ingredient in ACAMPROSATE CALCIUM is acamprosate calcium. There is one drug master file entry for this compound. Eleven suppliers are listed for this compound. Additional details are available on the acamprosate calcium profile page.
The generic ingredient in ACAMPROSATE CALCIUM is acamprosate calcium. There is one drug master file entry for this compound. Eleven suppliers are listed for this compound. Additional details are available on the acamprosate calcium profile page.
Summary for 200142
| Tradename: | ACAMPROSATE CALCIUM |
| Applicant: | Mylan |
| Ingredient: | acamprosate calcium |
| Patents: | 0 |
Suppliers and Packaging for NDA: 200142
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ACAMPROSATE CALCIUM | acamprosate calcium | TABLET, DELAYED RELEASE;ORAL | 200142 | ANDA | Mylan Pharmaceuticals Inc. | 0378-6333 | 0378-6333-80 | 180 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (0378-6333-80) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, DELAYED RELEASE;ORAL | Strength | 333MG | ||||
| Approval Date: | Mar 11, 2014 | TE: | AB | RLD: | No | ||||
Complete Access Available with Subscription
