Details for New Drug Application (NDA): 078654
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NDA 078654 describes CLONAZEPAM, which is a drug marketed by Alembic, Barr, Endo Operations, Sun Pharm Inds Inc, Accord Hlthcare, Actavis Elizabeth, Aurobindo Pharma Usa, Chartwell Rx, Norvium Bioscience, Prinston Inc, Rubicon, Sandoz, Teva, and Watson Labs, and is included in sixteen NDAs. It is available from thirty-two suppliers. Additional details are available on the CLONAZEPAM profile page.
The generic ingredient in CLONAZEPAM is clonazepam. There are ten drug master file entries for this compound. Thirty-three suppliers are listed for this compound. Additional details are available on the clonazepam profile page.
The generic ingredient in CLONAZEPAM is clonazepam. There are ten drug master file entries for this compound. Thirty-three suppliers are listed for this compound. Additional details are available on the clonazepam profile page.
Summary for 078654
| Tradename: | CLONAZEPAM |
| Applicant: | Sun Pharm Inds Inc |
| Ingredient: | clonazepam |
| Patents: | 0 |
Suppliers and Packaging for NDA: 078654
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CLONAZEPAM | clonazepam | TABLET, ORALLY DISINTEGRATING;ORAL | 078654 | ANDA | Sun Pharmaceutical Industries, Inc. | 57664-783 | 57664-783-83 | 30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (57664-783-83) |
| CLONAZEPAM | clonazepam | TABLET, ORALLY DISINTEGRATING;ORAL | 078654 | ANDA | Sun Pharmaceutical Industries, Inc. | 57664-783 | 57664-783-86 | 60 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (57664-783-86) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, ORALLY DISINTEGRATING;ORAL | Strength | 0.125MG | ||||
| Approval Date: | Aug 27, 2014 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, ORALLY DISINTEGRATING;ORAL | Strength | 0.25MG | ||||
| Approval Date: | Aug 27, 2014 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, ORALLY DISINTEGRATING;ORAL | Strength | 0.5MG | ||||
| Approval Date: | Aug 27, 2014 | TE: | AB | RLD: | No | ||||
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