Details for New Drug Application (NDA): 077147
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NDA 077147 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 077147
| Tradename: | CLONAZEPAM |
| Applicant: | Accord Hlthcare |
| Ingredient: | clonazepam |
| Patents: | 0 |
Suppliers and Packaging for NDA: 077147
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CLONAZEPAM | clonazepam | TABLET;ORAL | 077147 | ANDA | Accord Healthcare Inc. | 16729-136 | 16729-136-00 | 100 TABLET in 1 BOTTLE, PLASTIC (16729-136-00) |
| CLONAZEPAM | clonazepam | TABLET;ORAL | 077147 | ANDA | Accord Healthcare Inc. | 16729-136 | 16729-136-16 | 500 TABLET in 1 BOTTLE, PLASTIC (16729-136-16) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 0.5MG | ||||
| Approval Date: | May 2, 2005 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 1MG | ||||
| Approval Date: | May 2, 2005 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 2MG | ||||
| Approval Date: | May 2, 2005 | TE: | AB | RLD: | No | ||||
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