Assyro AI

FDA Orange Book · active-ingredient family

Meperidine hydrochloride

Meperidine hydrochloride is approved as 2 brand and 42 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:DEMEROL · NDA 021171

2

Brand (NDA)

42

Generics (ANDA)

0

Listed patents

0

Exclusivity periods

Brand (NDA) products · injectable, syrup, tablet

ProductApplicantApplicationTEApproved
DEMEROLRLD×4HOSPIRANDA 021171APApproved Prior to Jan 1, 1982
DEMEROLRLD×7QUAGENNDA 005010—Approved Prior to Jan 1, 1982

Generic (ANDA) products (42)

ProductApplicantApplicationTEApproved
MEPERIDINE HYDROCHLORIDE×4GENUSANDA 040893AAJun 24, 2009
MEPERIDINE HYDROCHLORIDE×2SUN PHARM INDS INCANDA 040446—Aug 08, 2002
MEPERIDINE HYDROCHLORIDE×2SPECGX LLCANDA 040352—Jun 13, 2000
MEPERIDINE HYDROCHLORIDE×2DURAMED PHARMS BARRANDA 040318—Oct 05, 1999
MEPERIDINE HYDROCHLORIDE×2EPIC PHARMA LLCANDA 040331AAMay 28, 1999
MEPERIDINE HYDROCHLORIDE PRESERVATIVE FREEHOSPIRAANDA 040305—Mar 10, 1999
MEPERIDINE HYDROCHLORIDE×2STRIDES PHARMA INTLANDA 040191—Dec 17, 1998
MEPERIDINE HYDROCHLORIDE×2WATSON LABSANDA 040186—Jun 30, 1997
MEPERIDINE HYDROCHLORIDE PRESERVATIVE FREESPECGX LLCANDA 040163—May 12, 1997
MEPERIDINE HYDROCHLORIDE×2HIKMAANDA 040110—Mar 12, 1997
MEPERIDINE HYDROCHLORIDE PRESERVATIVE FREEINTL MEDICATIONANDA 081309—Aug 30, 1993
MEPERIDINE HYDROCHLORIDE PRESERVATIVE FREEWEST-WARD PHARMS INTANDA 081002—Jul 30, 1993
MEPERIDINE HYDROCHLORIDEWATSON LABSANDA 073444—Mar 17, 1992
MEPERIDINE HYDROCHLORIDEWATSON LABSANDA 073445—Mar 17, 1992
MEPERIDINE HYDROCHLORIDE PRESERVATIVE FREEWATSON LABSANDA 073443—Mar 17, 1992
MEPERIDINE HYDROCHLORIDEIGI LABS INCANDA 089781—Mar 31, 1989
MEPERIDINE HYDROCHLORIDEIGI LABS INCANDA 089782—Mar 31, 1989
MEPERIDINE HYDROCHLORIDEIGI LABS INCANDA 089783—Mar 31, 1989
MEPERIDINE HYDROCHLORIDEIGI LABS INCANDA 089784—Mar 31, 1989
MEPERIDINE HYDROCHLORIDEIGI LABS INCANDA 089785—Mar 31, 1989
MEPERIDINE HYDROCHLORIDEIGI LABS INCANDA 089786—Mar 31, 1989
MEPERIDINE HYDROCHLORIDEIGI LABS INCANDA 089787—Mar 31, 1989
MEPERIDINE HYDROCHLORIDEIGI LABS INCANDA 089788—Mar 31, 1989
MEPERIDINE HYDROCHLORIDEHIKMAANDA 088744—Jan 30, 1985
MEPERIDINE HYDROCHLORIDEBARRANDA 088640—Sep 19, 1984
MEPERIDINE HYDROCHLORIDE PRESERVATIVE FREERLDICU MEDICAL INCANDA 088432—Aug 16, 1984
MEPERIDINE HYDROCHLORIDEBARRANDA 088639—Jul 02, 1984
MEPERIDINE HYDROCHLORIDEBAXTER HLTHCAREANDA 088279—Jun 15, 1984
MEPERIDINE HYDROCHLORIDEBAXTER HLTHCAREANDA 088280—Jun 15, 1984
MEPERIDINE HYDROCHLORIDEBAXTER HLTHCAREANDA 088281—Jun 15, 1984
MEPERIDINE HYDROCHLORIDEBAXTER HLTHCAREANDA 088282—Jun 15, 1984
MEPERIDINE HYDROCHLORIDEABBOTTANDA 080388—Approved Prior to Jan 1, 1982
MEPERIDINE HYDROCHLORIDEABBOTTANDA 080385—Approved Prior to Jan 1, 1982
MEPERIDINE HYDROCHLORIDEABBOTTANDA 080387—Approved Prior to Jan 1, 1982
MEPERIDINE HYDROCHLORIDEABBOTTANDA 080389—Approved Prior to Jan 1, 1982
MEPERIDINE HYDROCHLORIDEABBOTTANDA 080386—Approved Prior to Jan 1, 1982
MEPERIDINE HYDROCHLORIDEINTL MEDICATIONANDA 086332—Approved Prior to Jan 1, 1982
MEPERIDINE HYDROCHLORIDE×3PARKE DAVISANDA 080364—Approved Prior to Jan 1, 1982
MEPERIDINE HYDROCHLORIDE×4WEST-WARD PHARMS INTANDA 080445APApproved Prior to Jan 1, 1982
MEPERIDINE HYDROCHLORIDE×4WEST-WARD PHARMS INTANDA 080455APApproved Prior to Jan 1, 1982
MEPERIDINE HYDROCHLORIDE×2SUN PHARM INDUSTRIESANDA 080448—Approved Prior to Jan 1, 1982
MEPERIDINE HYDROCHLORIDEWYETH AYERSTANDA 080454—Approved 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.

Meperidine 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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