Details for New Drug Application (NDA): 021615
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The generic ingredient in RAZADYNE ER 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 021615
Tradename: | RAZADYNE ER |
Applicant: | Janssen Pharms |
Ingredient: | galantamine hydrobromide |
Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 021615
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | EQ 8MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
Approval Date: | Apr 1, 2005 | TE: | RLD: | Yes |
Profile for product number 002
Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | EQ 16MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
Approval Date: | Apr 1, 2005 | TE: | RLD: | Yes |
Profile for product number 003
Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | EQ 24MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
Approval Date: | Apr 1, 2005 | TE: | RLD: | Yes |
Expired US Patents for NDA 021615
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Janssen Pharms | RAZADYNE ER | galantamine hydrobromide | CAPSULE, EXTENDED RELEASE;ORAL | 021615-002 | Apr 1, 2005 | ⤷ Sign Up | ⤷ Sign Up |
Janssen Pharms | RAZADYNE ER | galantamine hydrobromide | CAPSULE, EXTENDED RELEASE;ORAL | 021615-001 | Apr 1, 2005 | ⤷ Sign Up | ⤷ Sign Up |
Janssen Pharms | RAZADYNE ER | galantamine hydrobromide | CAPSULE, EXTENDED RELEASE;ORAL | 021615-003 | Apr 1, 2005 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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