Details for New Drug Application (NDA): 021169
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The generic ingredient in RAZADYNE is galantamine hydrobromide. There are fifteen drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the galantamine hydrobromide profile page.
Summary for 021169
Tradename: | RAZADYNE |
Applicant: | Janssen Pharms |
Ingredient: | galantamine hydrobromide |
Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 021169
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | EQ 4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
Approval Date: | Feb 28, 2001 | TE: | RLD: | Yes |
Profile for product number 002
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | EQ 8MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
Approval Date: | Feb 28, 2001 | TE: | RLD: | Yes |
Profile for product number 003
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | EQ 12MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
Approval Date: | Feb 28, 2001 | TE: | RLD: | Yes |
Expired US Patents for NDA 021169
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Janssen Pharms | RAZADYNE | galantamine hydrobromide | TABLET;ORAL | 021169-001 | Feb 28, 2001 | ⤷ Sign Up | ⤷ Sign Up |
Janssen Pharms | RAZADYNE | galantamine hydrobromide | TABLET;ORAL | 021169-002 | Feb 28, 2001 | ⤷ Sign Up | ⤷ Sign Up |
Janssen Pharms | RAZADYNE | galantamine hydrobromide | TABLET;ORAL | 021169-002 | Feb 28, 2001 | ⤷ Sign Up | ⤷ Sign Up |
Janssen Pharms | RAZADYNE | galantamine hydrobromide | TABLET;ORAL | 021169-003 | Feb 28, 2001 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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