Assyro AI

FDA Orange Book · active-ingredient family

Promethazine hydrochloride

Promethazine hydrochloride is approved as 5 brand and 84 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:PROMETHAZINE HYDROCHLORIDE PLAIN · NDA 008381

5

Brand (NDA)

84

Generics (ANDA)

0

Listed patents

0

Exclusivity periods

Brand (NDA) products · injectable, suppository, syrup, tablet

ProductApplicantApplicationTEApproved
PROMETHAZINE HYDROCHLORIDE PLAINRLD×2ANI PHARMSNDA 008381—Apr 18, 1984
PHENERGANRLD×2PHARMOBEDIENTNDA 010926—Approved Prior to Jan 1, 1982
PHENERGANRLDPHARMOBEDIENTNDA 011689—Approved Prior to Jan 1, 1982
PHENERGANRLD×3DELCOR ASSET CORPNDA 007935—Approved Prior to Jan 1, 1982
PHENERGAN×2WYETH AYERSTNDA 008857—Approved Prior to Jan 1, 1982

Generic (ANDA) products (84)

ProductApplicantApplicationTEApproved
PROMETHAZINE HYDROCHLORIDE×2ANNORA PHARMAANDA 216446ABNov 02, 2022
PROMETHAZINE HYDROCHLORIDEQUAGENANDA 213890AAJul 12, 2021
PROMETHAZINE HYDROCHLORIDE×3STRIDES PHARMAANDA 209177—Jun 30, 2017
PROMETHAZINE HYDROCHLORIDECOSETTE PHARMS NCANDA 091675AAJun 28, 2012
PROMETHAZINE HYDROCHLORIDE×3AUROBINDO PHARMA USAANDA 091054—Aug 30, 2011
PROMETHAZINE HYDROCHLORIDE×3AMNEAL PHARMS NYANDA 091179ABDec 13, 2010
PROMETHAZINE HYDROCHLORIDEAMNEAL PHARMSANDA 040882—Dec 30, 2009
PROMETHAZINE HYDROCHLORIDESTRIDES PHARMAANDA 040891AAMar 13, 2009
PROMETHAZINE HYDROCHLORIDE×3SUN PHARM INDS INCANDA 040863—Dec 30, 2008
PROMETHAZINE HYDROCHLORIDE×2WOCKHARDT BIO AGANDA 040785—Sep 26, 2008
PROMETHAZINE HYDROCHLORIDE×2XGEN PHARMSANDA 040737APApr 24, 2008
PROMETHAZINE HYDROCHLORIDE×3QUAGENANDA 040673ABMar 05, 2008
PROMETHAZINE HYDROCHLORIDE×3IMPAX LABSANDA 040791—Feb 12, 2008
PROMETHAZINE HYDROCHLORIDE×3KVK TECHANDA 040712ABMay 04, 2007
PROMETHAZINE HYDROCHLORIDESUN PHARMA CANADAANDA 040718—Apr 04, 2007
PROMETHAZINE HYDROCHLORIDE×2SANDOZANDA 040593—Nov 08, 2006
PROMETHAZINE HYDROCHLORIDE×2SUN PHARMA CANADAANDA 040603—Oct 26, 2006
PROMETHAZINE HYDROCHLORIDE×3PRINSTON INCANDA 040622ABJul 18, 2006
PROMETHAZINE HYDROCHLORIDEPHARM ASSOCANDA 040643AAApr 26, 2006
PROMETHAZINE HYDROCHLORIDE×3ZYDUS PHARMS USAANDA 040596ABNov 18, 2005
PROMETHAZINE HYDROCHLORIDE×3ABLEANDA 040558—Jul 01, 2004
PROMETHAZINE HYDROCHLORIDE×2BEDFORD LABSANDA 040524—Mar 17, 2004
PROMETHAZINE HYDROCHLORIDE×2PADAGIS ISRAELANDA 040500ABJun 30, 2003
PROMETHAZINE HYDROCHLORIDE×2WATSON LABS INCANDA 040479—Jun 24, 2003
PROMETHAZINE HYDROCHLORIDE×2ABLEANDA 040504—Apr 11, 2003
PROMETHAZINE HYDROCHLORIDE×2COSETTE PHARMS NCANDA 040428ABMar 31, 2003
PROMETHAZINE HYDROCHLORIDEAM REGENTANDA 040515—Mar 19, 2003
PROMETHAZINE HYDROCHLORIDEABLEANDA 040449—Feb 27, 2003
PROMETHAZINE HYDROCHLORIDEMYLAN INSTITUTIONALANDA 040471—Nov 21, 2002
PROMETHAZINE HYDROCHLORIDE×2TEVA PHARMS USAANDA 040454—Aug 22, 2002
PROMETHAZINE HYDROCHLORIDE×2HOSPIRAANDA 040372—Jun 08, 2000
PROMETHAZINE HYDROCHLORIDECHARTWELL RXANDA 040026AASep 25, 1998
PROMETHAZINE HYDROCHLORIDEMARSAM PHARMS LLCANDA 089463—May 02, 1988
PROMETHAZINE HYDROCHLORIDEMARSAM PHARMS LLCANDA 089477—May 02, 1988
PROMETHEGANCOSETTE PHARMS NCANDA 087165—Aug 14, 1987
PROMETHAZINECENCIANDA 089013—Sep 20, 1985
PROMETHAZINE HYDROCHLORIDETEVAANDA 089109—Sep 10, 1985
MYMETHAZINE FORTISUSL PHARMAANDA 087996—Jan 18, 1983
PROMETHAZINE PLAINRLDPHARMOBEDIENTANDA 087953AANov 15, 1982
PROMETHAZINE HYDROCHLORIDEIMPAX LABSANDA 084214—Jul 07, 1982
PROMETHAZINE HYDROCHLORIDEABBOTTANDA 084223—Approved Prior to Jan 1, 1982
PROMETHAZINE HYDROCHLORIDEABBOTTANDA 084222—Approved Prior to Jan 1, 1982
PROMETHAZINE HYDROCHLORIDE×2EPIC PHARMA LLCANDA 083955—Approved Prior to Jan 1, 1982
PROMETHAZINE HYDROCHLORIDERLD×2HIKMAANDA 083312APApproved Prior to Jan 1, 1982
PROMETHAZINE HYDROCHLORIDEHOSPIRAANDA 083838—Approved Prior to Jan 1, 1982
PROMETHAZINE HYDROCHLORIDE×2WATSON LABSANDA 083532—Approved Prior to Jan 1, 1982
PROMETHAZINE HYDROCHLORIDEWATSON LABSANDA 084591—Approved Prior to Jan 1, 1982
PROMETHAZINE HYDROCHLORIDEWATSON LABSANDA 080629—Approved Prior to Jan 1, 1982
ZIPAN-25×2ALTANAANDA 083997—Approved Prior to Jan 1, 1982
PROMETHACONPOLYMEDICAANDA 084901—Approved Prior to Jan 1, 1982
PROMETHACONPOLYMEDICAANDA 084902—Approved Prior to Jan 1, 1982
PROMETH FORTISALPHARMA US PHARMSANDA 084772—Approved Prior to Jan 1, 1982
PROMETH PLAINACTAVIS MID ATLANTICANDA 085953—Approved Prior to Jan 1, 1982
PROMETHAZINE HYDROCHLORIDEKV PHARMANDA 085388—Approved Prior to Jan 1, 1982
PROMETHAZINE HYDROCHLORIDEKV PHARMANDA 085385—Approved Prior to Jan 1, 1982
PROMETHAZINE HYDROCHLORIDEPHARM ASSOCANDA 087518—Approved Prior to Jan 1, 1982
PROMETHAZINE HYDROCHLORIDEWHITEWORTH TOWN PLSNANDA 086395—Approved Prior to Jan 1, 1982
PROMETHAZINE HYDROCHLORIDEABBOTTANDA 084160—Approved Prior to Jan 1, 1982
PROMETHAZINE HYDROCHLORIDEABBOTTANDA 084166—Approved Prior to Jan 1, 1982
PROMETHAZINE HYDROCHLORIDEABBOTTANDA 084539—Approved Prior to Jan 1, 1982
PROMETHAZINE HYDROCHLORIDE×3CHARTWELL MOLECULARANDA 080949—Approved Prior to Jan 1, 1982
PROMETHAZINE HYDROCHLORIDEIVAX SUB TEVA PHARMSANDA 083604—Approved Prior to Jan 1, 1982
PROMETHAZINE HYDROCHLORIDEIVAX SUB TEVA PHARMSANDA 083603—Approved Prior to Jan 1, 1982
PROMETHAZINE HYDROCHLORIDEIVAX SUB TEVA PHARMSANDA 083613—Approved Prior to Jan 1, 1982
PROMETHAZINE HYDROCHLORIDEPVT FORMANDA 083214—Approved Prior to Jan 1, 1982
PROMETHAZINE HYDROCHLORIDEPVT FORMANDA 083658—Approved Prior to Jan 1, 1982
PROMETHAZINE HYDROCHLORIDERISINGANDA 084233—Approved Prior to Jan 1, 1982
PROMETHAZINE HYDROCHLORIDE×2RISINGANDA 085146—Approved Prior to Jan 1, 1982
PROMETHAZINE HYDROCHLORIDERLD×3SANDOZANDA 084176ABApproved Prior to Jan 1, 1982
PROMETHAZINE HYDROCHLORIDESUN PHARM INDUSTRIESANDA 084555—Approved Prior to Jan 1, 1982
PROMETHAZINE HYDROCHLORIDESUN PHARM INDUSTRIESANDA 084554—Approved Prior to Jan 1, 1982
PROMETHAZINE HYDROCHLORIDESUN PHARM INDUSTRIESANDA 084557—Approved Prior to Jan 1, 1982
PROMETHAZINE HYDROCHLORIDETABLICAPSANDA 084080—Approved Prior to Jan 1, 1982
PROMETHAZINE HYDROCHLORIDETABLICAPSANDA 084027—Approved Prior to Jan 1, 1982
PROMETHAZINE HYDROCHLORIDEWATSON LABSANDA 083401—Approved Prior to Jan 1, 1982
PROMETHAZINE HYDROCHLORIDEWATSON LABSANDA 083712—Approved Prior to Jan 1, 1982
PROMETHAZINE HYDROCHLORIDEWATSON LABSANDA 085986—Approved Prior to Jan 1, 1982
PROMETHAZINE HYDROCHLORIDEWATSON LABSANDA 083204—Approved Prior to Jan 1, 1982
PROMETHAZINE HYDROCHLORIDEWATSON LABSANDA 083426ABApproved Prior to Jan 1, 1982
PROMETHAZINE HYDROCHLORIDEWATSON LABSANDA 085684—Approved Prior to Jan 1, 1982
PROMETHAZINE HYDROCHLORIDEWATSON LABSANDA 083403—Approved Prior to Jan 1, 1982
PROMETHAZINE HYDROCHLORIDEWATSON LABSANDA 083711ABApproved Prior to Jan 1, 1982
PROMETHAZINE HYDROCHLORIDEWATSON LABSANDA 085664—Approved Prior to Jan 1, 1982
REMSED×2BRISTOL MYERS SQUIBBANDA 083176—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.

Promethazine 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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