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FDA Orange Book · active-ingredient family

Hydrochlorothiazide; propranolol hydrochloride

Hydrochlorothiazide; propranolol hydrochloride is approved as 2 brand and 17 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:INDERIDE-40/25 · NDA 018031

2

Brand (NDA)

17

Generics (ANDA)

0

Listed patents

0

Exclusivity periods

Brand (NDA) products · capsule, extended release, tablet

ProductApplicantApplicationTEApproved
INDERIDE-40/25RLD×2WYETH PHARMS INCNDA 018031—Approved Prior to Jan 1, 1982
INDERIDE LA 120/50×3WYETH AYERSTNDA 019059—Jul 03, 1985

Generic (ANDA) products (17)

ProductApplicantApplicationTEApproved
PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDEWATSON LABSANDA 071498—Dec 18, 1991
PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDEWATSON LABSANDA 071501—Dec 18, 1991
PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDEIVAX SUB TEVA PHARMSANDA 071552—Dec 01, 1988
PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDEIVAX SUB TEVA PHARMSANDA 071553—Dec 01, 1988
PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE×2ANI PHARMSANDA 072043—Mar 14, 1988
PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDEWARNER CHILCOTTANDA 071771—Jan 26, 1988
PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDEWARNER CHILCOTTANDA 071772—Jan 26, 1988
PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDECHARTWELL RXANDA 071060—Aug 26, 1987
PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDECHARTWELL RXANDA 071061—Aug 26, 1987
PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE×2RISINGANDA 070947—Mar 04, 1987
PROPRANOLOL HYDROCHLORIDE & HYDROCHLOROTHIAZIDEDURAMED PHARMS BARRANDA 071126—Mar 02, 1987
PROPRANOLOL HYDROCHLORIDE & HYDROCHLOROTHIAZIDEDURAMED PHARMS BARRANDA 071127—Mar 02, 1987
PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE×2ANI PHARMSANDA 070705—Oct 01, 1986
PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDEACTAVIS ELIZABETHANDA 070851—May 15, 1986
PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDEACTAVIS ELIZABETHANDA 070852—May 15, 1986
PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDEWATSON LABSANDA 070301—Apr 18, 1986
PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDEWATSON LABSANDA 070305—Apr 18, 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; propranolol hydrochloride — frequently asked questions

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

Agent CTA Background

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