Details for New Drug Application (NDA): 205995
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NDA 205995 describes ACAMPROSATE CALCIUM, which is a drug marketed by Barr Labs Div Teva, Glenmark Pharms Ltd, Mylan, and Zydus Pharms, and is included in four NDAs. It is available from six suppliers. Additional details are available on the ACAMPROSATE CALCIUM profile page.
The generic ingredient in ACAMPROSATE CALCIUM 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 ACAMPROSATE CALCIUM 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 205995
| Tradename: | ACAMPROSATE CALCIUM |
| Applicant: | Zydus Pharms |
| Ingredient: | acamprosate calcium |
| Patents: | 0 |
Suppliers and Packaging for NDA: 205995
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ACAMPROSATE CALCIUM | acamprosate calcium | TABLET, DELAYED RELEASE;ORAL | 205995 | ANDA | Zydus Pharmaceuticals (USA) Inc. | 68382-569 | 68382-569-01 | 100 TABLET, DELAYED RELEASE in 1 BOTTLE (68382-569-01) |
| ACAMPROSATE CALCIUM | acamprosate calcium | TABLET, DELAYED RELEASE;ORAL | 205995 | ANDA | Zydus Pharmaceuticals (USA) Inc. | 68382-569 | 68382-569-05 | 500 TABLET, DELAYED RELEASE in 1 BOTTLE (68382-569-05) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, DELAYED RELEASE;ORAL | Strength | 333MG | ||||
| Approval Date: | May 26, 2017 | TE: | AB | RLD: | No | ||||
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