Assyro AI

FDA Orange Book · active-ingredient family

Trichlormethiazide

Trichlormethiazide is approved as 2 brand and 13 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:METAHYDRIN · NDA 012594

2

Brand (NDA)

13

Generics (ANDA)

0

Listed patents

0

Exclusivity periods

Brand (NDA) products · tablet

ProductApplicantApplicationTEApproved
METAHYDRIN×2SANOFI AVENTIS USNDA 012594Jun 16, 1988
NAQUA×2SCHERINGNDA 012265Approved Prior to Jan 1, 1982

Generic (ANDA) products (13)

ProductApplicantApplicationTEApproved
TRICHLOREXLANNETTANDA 083436Approved Prior to Jan 1, 1982
TRICHLOREXLANNETTANDA 085630Approved Prior to Jan 1, 1982
TRICHLORMASMAST MMANDA 086259Approved Prior to Jan 1, 1982
TRICHLORMETHIAZIDECHARTWELL RXANDA 085568Approved Prior to Jan 1, 1982
TRICHLORMETHIAZIDEIMPAX LABSANDA 083967Approved Prior to Jan 1, 1982
TRICHLORMETHIAZIDEPAR PHARMANDA 087007Approved Prior to Jan 1, 1982
TRICHLORMETHIAZIDEPAR PHARMANDA 087005Approved Prior to Jan 1, 1982
TRICHLORMETHIAZIDESANDOZANDA 086171Approved Prior to Jan 1, 1982
TRICHLORMETHIAZIDEWATSON LABSANDA 083847Approved Prior to Jan 1, 1982
TRICHLORMETHIAZIDEWATSON LABSANDA 086458Approved Prior to Jan 1, 1982
TRICHLORMETHIAZIDEWATSON LABSANDA 083462Approved Prior to Jan 1, 1982
TRICHLORMETHIAZIDEWATSON LABSANDA 083855Approved Prior to Jan 1, 1982
TRICHLORMETHIAZIDEWATSON LABSANDA 085962Approved Prior to Jan 1, 1982

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.

Trichlormethiazide — 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.