Hydrochlorothiazide; labetalol hydrochloride - Generic Drug Details
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What are the generic drug sources for hydrochlorothiazide; labetalol hydrochloride and what is the scope of freedom to operate?
Hydrochlorothiazide; labetalol hydrochloride
is the generic ingredient in two branded drugs marketed by Schering and Glaxosmithkline, and is included in two NDAs. Additional information is available in the individual branded drug profile pages.Summary for hydrochlorothiazide; labetalol hydrochloride
| US Patents: | 0 |
| Tradenames: | 2 |
| Applicants: | 2 |
| NDAs: | 2 |
| Clinical Trials: | 1 |
| DailyMed Link: | hydrochlorothiazide; labetalol hydrochloride at DailyMed |
Recent Clinical Trials for hydrochlorothiazide; labetalol hydrochloride
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| VA Office of Research and Development | |
| US Department of Veterans Affairs |
See all hydrochlorothiazide; labetalol hydrochloride clinical trials
Anatomical Therapeutic Chemical (ATC) Classes for hydrochlorothiazide; labetalol hydrochloride
US Patents and Regulatory Information for hydrochlorothiazide; labetalol hydrochloride
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Schering | NORMOZIDE | hydrochlorothiazide; labetalol hydrochloride | TABLET;ORAL | 019046-004 | Apr 6, 1987 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Glaxosmithkline | TRANDATE HCT | hydrochlorothiazide; labetalol hydrochloride | TABLET;ORAL | 019174-002 | Apr 10, 1987 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Schering | NORMOZIDE | hydrochlorothiazide; labetalol hydrochloride | TABLET;ORAL | 019046-002 | Apr 6, 1987 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Schering | NORMOZIDE | hydrochlorothiazide; labetalol hydrochloride | TABLET;ORAL | 019046-003 | Apr 6, 1987 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for hydrochlorothiazide; labetalol hydrochloride
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Glaxosmithkline | TRANDATE HCT | hydrochlorothiazide; labetalol hydrochloride | TABLET;ORAL | 019174-004 | Apr 10, 1987 | ⤷ Sign Up | ⤷ Sign Up |
| Glaxosmithkline | TRANDATE HCT | hydrochlorothiazide; labetalol hydrochloride | TABLET;ORAL | 019174-003 | Apr 10, 1987 | ⤷ Sign Up | ⤷ Sign Up |
| Glaxosmithkline | TRANDATE HCT | hydrochlorothiazide; labetalol hydrochloride | TABLET;ORAL | 019174-002 | Apr 10, 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 |
