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FDA Orange Book · active-ingredient family

Hydrochlorothiazide; moexipril hydrochloride

Hydrochlorothiazide; moexipril hydrochloride is approved as 1 brand and 4 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:UNIRETIC · NDA 020729

1

Brand (NDA)

4

Generics (ANDA)

0

Listed patents

0

Exclusivity periods

Brand (NDA) products · tablet

ProductApplicantApplicationTEApproved
UNIRETIC×3UCB INCNDA 020729Jun 27, 1997

Generic (ANDA) products (4)

ProductApplicantApplicationTEApproved
MOEXIPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE×3HERITAGEANDA 202150Mar 07, 2014
MOEXIPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE×3GLENMARK PHARMSANDA 090718Mar 17, 2010
MOEXIPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE×3CHARTWELL RXANDA 090096Sep 25, 2008
MOEXIPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE×3TEVAANDA 076980Mar 07, 2007

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; moexipril hydrochloride — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Agent CTA Background

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.