Details for New Drug Application (NDA): 019046
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The generic ingredient in NORMOZIDE 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 019046
Tradename: | NORMOZIDE |
Applicant: | Schering |
Ingredient: | hydrochlorothiazide; labetalol hydrochloride |
Patents: | 0 |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 25MG;100MG | ||||
Approval Date: | Apr 6, 1987 | TE: | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 25MG;200MG | ||||
Approval Date: | Apr 6, 1987 | TE: | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 25MG;300MG | ||||
Approval Date: | Apr 6, 1987 | TE: | RLD: | No |
Expired US Patents for NDA 019046
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Schering | NORMOZIDE | hydrochlorothiazide; labetalol hydrochloride | TABLET;ORAL | 019046-002 | Apr 6, 1987 | ⤷ Sign Up | ⤷ Sign Up |
Schering | NORMOZIDE | hydrochlorothiazide; labetalol hydrochloride | TABLET;ORAL | 019046-001 | Apr 6, 1987 | ⤷ Sign Up | ⤷ Sign Up |
Schering | NORMOZIDE | hydrochlorothiazide; labetalol hydrochloride | TABLET;ORAL | 019046-004 | Apr 6, 1987 | ⤷ Sign Up | ⤷ Sign Up |
Schering | NORMOZIDE | hydrochlorothiazide; labetalol hydrochloride | TABLET;ORAL | 019046-002 | Apr 6, 1987 | ⤷ Sign Up | ⤷ Sign Up |
Schering | NORMOZIDE | hydrochlorothiazide; labetalol hydrochloride | TABLET;ORAL | 019046-003 | Apr 6, 1987 | ⤷ Sign Up | ⤷ Sign Up |
Schering | NORMOZIDE | hydrochlorothiazide; labetalol hydrochloride | TABLET;ORAL | 019046-001 | Apr 6, 1987 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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