Details for New Drug Application (NDA): 074869
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NDA 074869 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 074869
| Tradename: | CLONAZEPAM |
| Applicant: | Actavis Elizabeth |
| Ingredient: | clonazepam |
| Patents: | 0 |
Suppliers and Packaging for NDA: 074869
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CLONAZEPAM | clonazepam | TABLET;ORAL | 074869 | ANDA | Medsource Pharmaceuticals | 45865-575 | 45865-575-30 | 30 TABLET in 1 BOTTLE (45865-575-30) |
| CLONAZEPAM | clonazepam | TABLET;ORAL | 074869 | ANDA | Medsource Pharmaceuticals | 45865-575 | 45865-575-60 | 60 TABLET in 1 BOTTLE (45865-575-60) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 0.5MG | ||||
| Approval Date: | Oct 31, 1996 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 1MG | ||||
| Approval Date: | Oct 31, 1996 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 2MG | ||||
| Approval Date: | Oct 31, 1996 | TE: | AB | RLD: | No | ||||
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