Details for New Drug Application (NDA): 021590
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The generic ingredient in FAZACLO ODT is clozapine. There are thirteen drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the clozapine profile page.
Summary for 021590
Tradename: | FAZACLO ODT |
Applicant: | Jazz |
Ingredient: | clozapine |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Medical Subject Heading (MeSH) Categories for 021590
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET, ORALLY DISINTEGRATING;ORAL | Strength | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
Approval Date: | Feb 10, 2004 | TE: | RLD: | Yes |
Profile for product number 002
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET, ORALLY DISINTEGRATING;ORAL | Strength | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
Approval Date: | Feb 10, 2004 | TE: | RLD: | Yes |
Profile for product number 003
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET, ORALLY DISINTEGRATING;ORAL | Strength | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
Approval Date: | Jun 3, 2005 | TE: | RLD: | No |
Expired US Patents for NDA 021590
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Jazz | FAZACLO ODT | clozapine | TABLET, ORALLY DISINTEGRATING;ORAL | 021590-001 | Feb 10, 2004 | ⤷ Sign Up | ⤷ Sign Up |
Jazz | FAZACLO ODT | clozapine | TABLET, ORALLY DISINTEGRATING;ORAL | 021590-005 | Jul 9, 2010 | ⤷ Sign Up | ⤷ Sign Up |
Jazz | FAZACLO ODT | clozapine | TABLET, ORALLY DISINTEGRATING;ORAL | 021590-002 | Feb 10, 2004 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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