FDA Orange Book · active-ingredient family
Hydrochlorothiazide; labetalol hydrochloride
Hydrochlorothiazide; labetalol hydrochloride is approved in 2 FDA applications, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
Reference-listed drug:TRANDATE HCT · NDA 019174
2
Brand (NDA)
0
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| TRANDATE HCT×4 | GLAXOSMITHKLINE | NDA 019174 | — | Apr 10, 1987 | |
| NORMOZIDE×4 | SCHERING | NDA 019046 | — | Apr 06, 1987 |
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Hydrochlorothiazide; labetalol hydrochloride — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
