Details for New Drug Application (NDA): 075150
✉ Email this page to a colleague
NDA 075150 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 075150
| Tradename: | CLONAZEPAM |
| Applicant: | Aurobindo Pharma Usa |
| Ingredient: | clonazepam |
| Patents: | 0 |
Suppliers and Packaging for NDA: 075150
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CLONAZEPAM | clonazepam | TABLET;ORAL | 075150 | ANDA | Aurobindo Pharma Limited | 59651-722 | 59651-722-01 | 100 TABLET in 1 BOTTLE (59651-722-01) |
| CLONAZEPAM | clonazepam | TABLET;ORAL | 075150 | ANDA | Aurobindo Pharma Limited | 59651-722 | 59651-722-99 | 1000 TABLET in 1 BOTTLE (59651-722-99) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 0.5MG | ||||
| Approval Date: | Oct 5, 1998 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 1MG | ||||
| Approval Date: | Oct 5, 1998 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 2MG | ||||
| Approval Date: | Oct 5, 1998 | TE: | AB | RLD: | No | ||||
Complete Access Available with Subscription
