Details for New Drug Application (NDA): 018830
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The generic ingredient in TAMBOCOR is flecainide acetate. There are ten drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the flecainide acetate profile page.
Summary for 018830
Tradename: | TAMBOCOR |
Applicant: | Alvogen |
Ingredient: | flecainide acetate |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Medical Subject Heading (MeSH) Categories for 018830
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
Approval Date: | Oct 31, 1985 | TE: | RLD: | Yes |
Profile for product number 002
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
Approval Date: | Oct 31, 1985 | TE: | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
Approval Date: | Jun 3, 1988 | TE: | RLD: | Yes |
Expired US Patents for NDA 018830
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Alvogen | TAMBOCOR | flecainide acetate | TABLET;ORAL | 018830-003 | Jun 3, 1988 | ⤷ Try a Trial | ⤷ Try a Trial |
Alvogen | TAMBOCOR | flecainide acetate | TABLET;ORAL | 018830-003 | Jun 3, 1988 | ⤷ Try a Trial | ⤷ Try a Trial |
Alvogen | TAMBOCOR | flecainide acetate | TABLET;ORAL | 018830-004 | Aug 23, 1988 | ⤷ Try a Trial | ⤷ Try a Trial |
Alvogen | TAMBOCOR | flecainide acetate | TABLET;ORAL | 018830-001 | Oct 31, 1985 | ⤷ Try a Trial | ⤷ Try a Trial |
Alvogen | TAMBOCOR | flecainide acetate | TABLET;ORAL | 018830-004 | Aug 23, 1988 | ⤷ Try a Trial | ⤷ Try a Trial |
Alvogen | TAMBOCOR | flecainide acetate | TABLET;ORAL | 018830-003 | Jun 3, 1988 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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