FDA Orange Book · active-ingredient family
Hydrochlorothiazide; olmesartan medoxomil
Hydrochlorothiazide; olmesartan medoxomil is approved as 1 brand and 16 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:BENICAR HCT · NDA 021532
1
Brand (NDA)
16
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| BENICAR HCTRLD×3 | COSETTE | NDA 021532 | AB | Jun 05, 2003 |
Generic (ANDA) products (16)
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; olmesartan medoxomil — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
