Details for New Drug Application (NDA): 018716
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The generic ingredient in TRANDATE is hydrochlorothiazide; labetalol hydrochloride. There are thirty-two drug master file entries for this compound. Additional details are available on the hydrochlorothiazide; labetalol hydrochloride profile page.
Summary for 018716
Tradename: | TRANDATE |
Applicant: | Alvogen |
Ingredient: | labetalol hydrochloride |
Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 018716
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DISCN | Dosage: | TABLET;ORAL | Strength | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||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: | May 24, 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DISCN | Dosage: | TABLET;ORAL | Strength | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||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: | Aug 1, 1984 | TE: | RLD: | Yes |
Profile for product number 003
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
Approval Date: | Aug 1, 1984 | TE: | RLD: | Yes |
Expired US Patents for NDA 018716
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Alvogen | TRANDATE | labetalol hydrochloride | TABLET;ORAL | 018716-001 | May 24, 1985 | ⤷ Sign Up | ⤷ Sign Up |
Alvogen | TRANDATE | labetalol hydrochloride | TABLET;ORAL | 018716-002 | Aug 1, 1984 | ⤷ Sign Up | ⤷ Sign Up |
Alvogen | TRANDATE | labetalol hydrochloride | TABLET;ORAL | 018716-003 | Aug 1, 1984 | ⤷ Sign Up | ⤷ Sign Up |
Alvogen | TRANDATE | labetalol hydrochloride | TABLET;ORAL | 018716-004 | Aug 1, 1984 | ⤷ Sign Up | ⤷ Sign Up |
Alvogen | TRANDATE | labetalol hydrochloride | TABLET;ORAL | 018716-004 | Aug 1, 1984 | ⤷ Sign Up | ⤷ Sign Up |
Alvogen | TRANDATE | labetalol hydrochloride | TABLET;ORAL | 018716-003 | Aug 1, 1984 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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