Details for New Drug Application (NDA): 020813
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NDA 020813 describes KLONOPIN RAPIDLY DISINTEGRATING, which is a drug marketed by Roche and is included in one NDA. Additional details are available on the KLONOPIN RAPIDLY DISINTEGRATING profile page.
The generic ingredient in KLONOPIN RAPIDLY DISINTEGRATING is clonazepam. There are ten drug master file entries for this compound. Thirty suppliers are listed for this compound. Additional details are available on the clonazepam profile page.
The generic ingredient in KLONOPIN RAPIDLY DISINTEGRATING is clonazepam. There are ten drug master file entries for this compound. Thirty suppliers are listed for this compound. Additional details are available on the clonazepam profile page.
Summary for 020813
| Tradename: | KLONOPIN RAPIDLY DISINTEGRATING |
| Applicant: | Roche |
| Ingredient: | clonazepam |
| Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 020813
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET, ORALLY DISINTEGRATING;ORAL | Strength | 0.125MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Dec 23, 1997 | TE: | RLD: | Yes | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET, ORALLY DISINTEGRATING;ORAL | Strength | 0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Dec 23, 1997 | TE: | RLD: | Yes | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET, ORALLY DISINTEGRATING;ORAL | Strength | 0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Dec 23, 1997 | TE: | RLD: | Yes | |||||
Expired US Patents for NDA 020813
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Roche | KLONOPIN RAPIDLY DISINTEGRATING | clonazepam | TABLET, ORALLY DISINTEGRATING;ORAL | 020813-005 | Dec 23, 1997 | 4,305,502 | ⤷ Start Trial |
| Roche | KLONOPIN RAPIDLY DISINTEGRATING | clonazepam | TABLET, ORALLY DISINTEGRATING;ORAL | 020813-002 | Dec 23, 1997 | 4,371,516 | ⤷ Start Trial |
| Roche | KLONOPIN RAPIDLY DISINTEGRATING | clonazepam | TABLET, ORALLY DISINTEGRATING;ORAL | 020813-005 | Dec 23, 1997 | 4,758,598 | ⤷ Start Trial |
| Roche | KLONOPIN RAPIDLY DISINTEGRATING | clonazepam | TABLET, ORALLY DISINTEGRATING;ORAL | 020813-001 | Dec 23, 1997 | 4,758,598 | ⤷ Start Trial |
| Roche | KLONOPIN RAPIDLY DISINTEGRATING | clonazepam | TABLET, ORALLY DISINTEGRATING;ORAL | 020813-001 | Dec 23, 1997 | 4,305,502 | ⤷ Start Trial |
| Roche | KLONOPIN RAPIDLY DISINTEGRATING | clonazepam | TABLET, ORALLY DISINTEGRATING;ORAL | 020813-004 | Dec 23, 1997 | 4,371,516 | ⤷ Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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