Details for New Drug Application (NDA): 018687
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The generic ingredient in NORMODYNE is labetalol hydrochloride. There are fourteen drug master file entries for this compound. Thirty-nine suppliers are listed for this compound. Additional details are available on the labetalol hydrochloride profile page.
Summary for 018687
Tradename: | NORMODYNE |
Applicant: | Schering |
Ingredient: | labetalol hydrochloride |
Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 018687
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DISCN | Dosage: | TABLET;ORAL | Strength | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||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: | Aug 31, 1987 | 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DISCN | Dosage: | TABLET;ORAL | Strength | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||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DISCN | Dosage: | TABLET;ORAL | Strength | 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||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 018687
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Schering | NORMODYNE | labetalol hydrochloride | TABLET;ORAL | 018687-002 | Aug 1, 1984 | ⤷ Sign Up | ⤷ Sign Up |
Schering | NORMODYNE | labetalol hydrochloride | TABLET;ORAL | 018687-001 | Aug 31, 1987 | ⤷ Sign Up | ⤷ Sign Up |
Schering | NORMODYNE | labetalol hydrochloride | TABLET;ORAL | 018687-004 | Aug 1, 1984 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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