Assyro AI

FDA Orange Book · active-ingredient family

Amitriptyline hydrochloride; perphenazine

Amitriptyline hydrochloride; perphenazine is approved as 2 brand and 35 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:ETRAFON 2-10 · NDA 014713

2

Brand (NDA)

35

Generics (ANDA)

0

Listed patents

0

Exclusivity periods

Brand (NDA) products · tablet

ProductApplicantApplicationTEApproved
ETRAFON 2-10×4SCHERINGNDA 014713—Approved Prior to Jan 1, 1982
TRIAVIL 2-10×5NEW RIVERNDA 014715—Approved Prior to Jan 1, 1982

Generic (ANDA) products (35)

ProductApplicantApplicationTEApproved
PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDECHARTWELL RXANDA 073007—Oct 17, 1991
PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDECHARTWELL RXANDA 073009—Oct 17, 1991
PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDECHARTWELL RXANDA 073008—Oct 17, 1991
PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDECHARTWELL RXANDA 073010—Oct 17, 1991
PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDEWATSON LABSANDA 072539—Feb 15, 1989
PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDEWATSON LABSANDA 072540—Feb 15, 1989
PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDEWATSON LABSANDA 072541—Feb 15, 1989
PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDEWATSON LABSANDA 072134—Feb 15, 1989
PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDEWATSON LABSANDA 072135—Feb 15, 1989
PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE×5MYLANANDA 071443—Nov 10, 1988
PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDECHARTWELL RXANDA 071863—Dec 21, 1987
PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDEFOSUN PHARMAANDA 071862—Dec 21, 1987
PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDEFOSUN PHARMAANDA 071062—Nov 27, 1987
PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDEFOSUN PHARMAANDA 071063—Nov 27, 1987
PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDEFOSUN PHARMAANDA 071064—Nov 27, 1987
PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDEWATSON LABSANDA 071558—Mar 02, 1987
PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDESUN PHARM INDUSTRIESANDA 071077—Nov 12, 1986
PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDESUN PHARM INDUSTRIESANDA 071078—Nov 12, 1986
PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDESUN PHARM INDUSTRIESANDA 070297—Nov 12, 1986
PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDESUN PHARM INDUSTRIESANDA 071079—Nov 12, 1986
PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDEWATSON LABSANDA 070377—Nov 04, 1986
PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDEIVAX SUB TEVA PHARMSANDA 070939—Sep 12, 1986
PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDEIVAX SUB TEVA PHARMSANDA 070935—Sep 11, 1986
PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDEIVAX SUB TEVA PHARMSANDA 070937—Sep 11, 1986
PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDEIVAX SUB TEVA PHARMSANDA 070936—Sep 11, 1986
PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDEIVAX SUB TEVA PHARMSANDA 070938—Sep 11, 1986
PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDEPAR PHARMANDA 070565—Sep 11, 1986
PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDEPAR PHARMANDA 070620—Sep 11, 1986
PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDEPAR PHARMANDA 070621—Sep 11, 1986
PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDEPAR PHARMANDA 070595—Sep 11, 1986
PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDEPAR PHARMANDA 070574—Sep 11, 1986
PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDEWATSON LABSANDA 070373—Aug 25, 1986
PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDEWATSON LABSANDA 070375—Aug 25, 1986
PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDEWATSON LABSANDA 070374—Aug 25, 1986
PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDEWATSON LABSANDA 070376—Aug 25, 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.

Amitriptyline hydrochloride; perphenazine — frequently asked questions

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

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