Assyro AI

FDA Orange Book · active-ingredient family

Hydrochlorothiazide; methyldopa

Hydrochlorothiazide; methyldopa is approved as 1 brand and 40 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:ALDORIL 15 · NDA 013402

1

Brand (NDA)

40

Generics (ANDA)

0

Listed patents

0

Exclusivity periods

Brand (NDA) products · tablet

ProductApplicantApplicationTEApproved
ALDORIL 15×4MERCKNDA 013402—Approved Prior to Jan 1, 1982

Generic (ANDA) products (40)

ProductApplicantApplicationTEApproved
METHYLDOPA AND HYDROCHLOROTHIAZIDEDAVA PHARMS INCANDA 072507—Jun 02, 1989
METHYLDOPA AND HYDROCHLOROTHIAZIDEDAVA PHARMS INCANDA 072508—Jun 02, 1989
METHYLDOPA AND HYDROCHLOROTHIAZIDEDAVA PHARMS INCANDA 072509—Jun 02, 1989
METHYLDOPA AND HYDROCHLOROTHIAZIDEDAVA PHARMS INCANDA 072510—Jun 02, 1989
METHYLDOPA AND HYDROCHLOROTHIAZIDEWATSON LABSANDA 070958—Feb 06, 1989
METHYLDOPA AND HYDROCHLOROTHIAZIDEWATSON LABSANDA 070960—Feb 06, 1989
METHYLDOPA AND HYDROCHLOROTHIAZIDEWATSON LABSANDA 070959—Jan 19, 1989
METHYLDOPA AND HYDROCHLOROTHIAZIDEWATSON LABSANDA 071069—Jan 19, 1989
METHYLDOPA AND HYDROCHLOROTHIAZIDEWATSON LABSANDA 071920—Aug 29, 1988
METHYLDOPA AND HYDROCHLOROTHIAZIDEWATSON LABSANDA 071921—Aug 29, 1988
METHYLDOPA AND HYDROCHLOROTHIAZIDEWATSON LABSANDA 071922—Aug 29, 1988
METHYLDOPA AND HYDROCHLOROTHIAZIDEWATSON LABSANDA 071923—Aug 29, 1988
METHYLDOPA AND HYDROCHLOROTHIAZIDETEVAANDA 071819—Apr 08, 1988
METHYLDOPA AND HYDROCHLOROTHIAZIDETEVAANDA 071820—Apr 08, 1988
METHYLDOPA AND HYDROCHLOROTHIAZIDETEVAANDA 071821—Apr 08, 1988
METHYLDOPA AND HYDROCHLOROTHIAZIDETEVAANDA 071822—Apr 08, 1988
METHYLDOPA AND HYDROCHLOROTHIAZIDEIVAX SUB TEVA PHARMSANDA 071458—Mar 08, 1988
METHYLDOPA AND HYDROCHLOROTHIAZIDEIVAX SUB TEVA PHARMSANDA 071459—Mar 08, 1988
METHYLDOPA AND HYDROCHLOROTHIAZIDEIVAX SUB TEVA PHARMSANDA 071460—Mar 08, 1988
METHYLDOPA AND HYDROCHLOROTHIAZIDEIVAX SUB TEVA PHARMSANDA 071461—Mar 08, 1988
METHYLDOPA AND HYDROCHLOROTHIAZIDEPARKE DAVISANDA 071897—Nov 23, 1987
METHYLDOPA AND HYDROCHLOROTHIAZIDEPARKE DAVISANDA 071898—Nov 23, 1987
METHYLDOPA AND HYDROCHLOROTHIAZIDEPARKE DAVISANDA 071899—Nov 23, 1987
METHYLDOPA AND HYDROCHLOROTHIAZIDEPARKE DAVISANDA 071900—Nov 23, 1987
METHYLDOPA AND HYDROCHLOROTHIAZIDESANDOZANDA 070829—Mar 09, 1987
METHYLDOPA AND HYDROCHLOROTHIAZIDESANDOZANDA 070830—Mar 09, 1987
METHYLDOPA AND HYDROCHLOROTHIAZIDE×4STRIDES PHARMA INTLANDA 070614—Feb 02, 1987
METHYLDOPA AND HYDROCHLOROTHIAZIDEPUREPAC PHARMANDA 070853—Oct 08, 1986
METHYLDOPA AND HYDROCHLOROTHIAZIDEPUREPAC PHARMANDA 070854—Oct 08, 1986
METHYLDOPA AND HYDROCHLOROTHIAZIDEPUREPAC PHARMANDA 070688—Apr 24, 1986
METHYLDOPA AND HYDROCHLOROTHIAZIDEPUREPAC PHARMANDA 070689—Apr 24, 1986
METHYLDOPA AND HYDROCHLOROTHIAZIDEWATSON LABSANDA 070366—Apr 16, 1986
METHYLDOPA AND HYDROCHLOROTHIAZIDEWATSON LABSANDA 070368—Apr 16, 1986
METHYLDOPA AND HYDROCHLOROTHIAZIDEWATSON LABSANDA 070365—Mar 19, 1986
METHYLDOPA AND HYDROCHLOROTHIAZIDEWATSON LABSANDA 070367—Mar 19, 1986
METHYLDOPA AND HYDROCHLOROTHIAZIDE×2RISINGANDA 070265—Jan 23, 1986
METHYLDOPA AND HYDROCHLOROTHIAZIDECHARTWELL RXANDA 070182—Jan 15, 1986
METHYLDOPA AND HYDROCHLOROTHIAZIDECHARTWELL RXANDA 070183—Jan 15, 1986
METHYLDOPA AND HYDROCHLOROTHIAZIDECHARTWELL RXANDA 070543—Jan 15, 1986
METHYLDOPA AND HYDROCHLOROTHIAZIDECHARTWELL RXANDA 070544—Jan 15, 1986

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; methyldopa — 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.

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