Assyro AI

FDA Orange Book · active-ingredient family

Acetaminophen; codeine phosphate

Acetaminophen; codeine phosphate is approved in 108 FDA applications, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.

0

Brand (NDA)

108

Generics (ANDA)

0

Listed patents

0

Exclusivity periods

Generic (ANDA) products (108)

ProductApplicantApplicationTEApproved
ACETAMINOPHEN AND CODEINE PHOSPHATE×3ELITE LABS INCANDA 212418AASep 10, 2019
ACETAMINOPHEN AND CODEINE PHOSPHATE×3HIBROW HLTHCAREANDA 211610AAJun 27, 2019
ACETAMINOPHEN AND CODEINE PHOSPHATE×3AUROLIFE PHARMA LLCANDA 202800AAApr 15, 2013
ACETAMINOPHEN AND CODEINE PHOSPHATECHARTWELL MOLECULARANDA 091238—Nov 10, 2011
ACETAMINOPHEN AND CODEINE PHOSPHATEAMNEAL PHARMS NYANDA 040779AAMay 29, 2008
CODRIXWATSON LABS FLORIDAANDA 040488—Mar 28, 2003
CODRIXWATSON LABS FLORIDAANDA 040441—Mar 27, 2003
CODRIXWATSON LABS FLORIDAANDA 040447—Feb 26, 2003
ACETAMINOPHEN AND CODEINE PHOSPHATE×3WATSON LABS FLORIDAANDA 040443—Jan 22, 2003
ACETAMINOPHEN AND CODEINE PHOSPHATEABLEANDA 040452—Aug 01, 2002
ACETAMINOPHEN AND CODEINE PHOSPHATEABLEANDA 040459—Aug 01, 2002
ACETAMINOPHEN AND CODEINE PHOSPHATE×3SPECGX LLCANDA 040419AAMay 31, 2001
ACETAMINOPHEN AND CODEINE PHOSPHATE×3DURAMED PHARMS BARRANDA 040223—Nov 18, 1997
ACETAMINOPHEN AND CODEINE PHOSPHATEDAVA PHARMS INCANDA 040098—Sep 20, 1996
ACETAMINOPHEN AND CODEINE PHOSPHATEPAI HOLDINGSANDA 040119—Apr 26, 1996
ACETAMINOPHEN AND CODEINE PHOSPHATECHARTWELLANDA 089997—Dec 28, 1994
ACETAMINOPHEN AND CODEINE PHOSPHATECHARTWELLANDA 089998—Dec 28, 1994
ACETAMINOPHEN AND CODEINE PHOSPHATECHARTWELLANDA 089999—Dec 28, 1994
ACETAMINOPHEN AND CODEINE PHOSPHATECHARTWELLANDA 089450—Oct 27, 1992
ACETAMINOPHEN AND CODEINE PHOSPHATEFOSUN PHARMAANDA 081250—Jul 16, 1992
ACETAMINOPHEN AND CODEINE PHOSPHATEFOSUN PHARMAANDA 081249—Jul 16, 1992
ACETAMINOPHEN AND CODEINE PHOSPHATEMIKARTANDA 089363—Sep 09, 1991
ACETAMINOPHEN AND CODEINE PHOSPHATEROXANEANDA 089511—Apr 25, 1989
ACETAMINOPHEN AND CODEINE PHOSPHATEROXANEANDA 089512—Apr 25, 1989
ACETAMINOPHEN AND CODEINE PHOSPHATEROXANEANDA 089513—Apr 25, 1989
ACETAMINOPHEN AND CODEINE PHOSPHATESTRIDES PHARMA INTLANDA 089990AASep 30, 1988
ACETAMINOPHEN AND CODEINE PHOSPHATESTRIDES PHARMA INTLANDA 089805AASep 30, 1988
ACETAMINOPHEN AND CODEINE PHOSPHATESTRIDES PHARMA INTLANDA 089828AASep 30, 1988
ACETAMINOPHEN AND CODEINE PHOSPHATE×3RHODES PHARMSANDA 089673—Feb 10, 1988
ACETAMINOPHEN AND CODEINE PHOSPHATEAM THERAPANDA 089478—Mar 03, 1987
ACETAMINOPHEN AND CODEINE PHOSPHATEAM THERAPANDA 089481—Mar 03, 1987
ACETAMINOPHEN AND CODEINE PHOSPHATEAM THERAPANDA 089479—Mar 03, 1987
ACETAMINOPHEN AND CODEINE PHOSPHATEAM THERAPANDA 089482—Mar 03, 1987
ACETAMINOPHEN AND CODEINE PHOSPHATEAM THERAPANDA 089480—Mar 03, 1987
ACETAMINOPHEN AND CODEINE PHOSPHATEAM THERAPANDA 089483—Mar 03, 1987
ACETAMINOPHEN AND CODEINE PHOSPHATEPUREPAC PHARMANDA 089080—Jul 17, 1986
ACETAMINOPHEN AND CODEINE PHOSPHATESUPERPHARMANDA 089253—May 19, 1986
ACETAMINOPHEN AND CODEINE PHOSPHATESUPERPHARMANDA 089254—May 19, 1986
ACETAMINOPHEN AND CODEINE PHOSPHATEMIKARTANDA 089231—Mar 03, 1986
ACETAMINOPHEN AND CODEINE PHOSPHATEMIKARTANDA 089238—Feb 25, 1986
ACETAMINOPHEN AND CODEINE PHOSPHATEMIKARTANDA 089244—Feb 25, 1986
ACETAMINOPHEN AND CODEINE PHOSPHATESUPERPHARMANDA 089183—Oct 18, 1985
ACETAMINOPHEN AND CODEINE PHOSPHATESUPERPHARMANDA 089184—Oct 18, 1985
ACETAMINOPHEN AND CODEINE PHOSPHATESUPERPHARMANDA 089185—Oct 18, 1985
ACETAMINOPHEN AND CODEINE PHOSPHATERLD×3ANI PHARMSANDA 088629—Mar 06, 1985
ACETAMINOPHEN AND CODEINE PHOSPHATETEVAANDA 088537—Jun 04, 1984
ACETAMINOPHEN AND CODEINE PHOSPHATETEVAANDA 088599—Jun 01, 1984
PAPA-DEINE #3VANGARDANDA 088037—Mar 20, 1984
PAPA-DEINE #4VANGARDANDA 088715—Mar 20, 1984
ACETAMINOPHEN AND CODEINE PHOSPHATEDURAMED PHARMS BARRANDA 088353—Feb 06, 1984
ACETAMINOPHEN AND CODEINE PHOSPHATEDURAMED PHARMS BARRANDA 088354—Feb 06, 1984
ACETAMINOPHEN AND CODEINE PHOSPHATEDURAMED PHARMS BARRANDA 088355—Feb 06, 1984
ACETAMINOPHEN AND CODEINE PHOSPHATETEVAANDA 088324—Dec 29, 1983
ACETAMINOPHEN AND CODEINE PHOSPHATEPURACAP PHARMANDA 087762—Dec 10, 1982
ACETAMINOPHEN AND CODEINE PHOSPHATEUSL PHARMAANDA 087919—Jun 22, 1982
ACETAMINOPHEN AND CODEINE PHOSPHATEUSL PHARMAANDA 087920—Jun 22, 1982
ACETAMINOPHEN AND CODEINE PHOSPHATEWATSON LABSANDA 087277—May 26, 1982
ACETAMINOPHEN AND CODEINE PHOSPHATEWATSON LABSANDA 087276—May 26, 1982
ACETAMINOPHEN AND CODEINE PHOSPHATEWATSON LABSANDA 087275—May 26, 1982
ACETAMINOPHEN AND CODEINE PHOSPHATEMUTUAL PHARMANDA 087653—Apr 13, 1982
PHENAPHEN W/ CODEINE NO. 2ROBINS AHANDA 084444—Approved Prior to Jan 1, 1982
PHENAPHEN W/ CODEINE NO. 3RLDROBINS AHANDA 084445—Approved Prior to Jan 1, 1982
PHENAPHEN W/ CODEINE NO. 4RLDROBINS AHANDA 084446—Approved Prior to Jan 1, 1982
PROVAL #3SOLVAYANDA 085685—Approved Prior to Jan 1, 1982
TYLENOL W/ CODEINE NO. 3ORTHO MCNEIL PHARMANDA 087422—Approved Prior to Jan 1, 1982
TYLENOL W/ CODEINE NO. 4ORTHO MCNEIL PHARMANDA 087421—Approved Prior to Jan 1, 1982
ACETAMINOPHEN AND CODEINE PHOSPHATERLDACTAVIS MID ATLANTICANDA 085861—Approved Prior to Jan 1, 1982
ACETAMINOPHEN AND CODEINE PHOSPHATEGENUS LIFESCIENCESANDA 087508—Approved Prior to Jan 1, 1982
ACETAMINOPHEN AND CODEINE PHOSPHATEPHARMOBEDIENTANDA 087006—Approved Prior to Jan 1, 1982
ACETAMINOPHEN AND CODEINE PHOSPHATESTRIDES PHARMAANDA 086366—Approved Prior to Jan 1, 1982
TYLENOL W/ CODEINERLDORTHO MCNEIL PHARMANDA 085057—Approved Prior to Jan 1, 1982
CAPITAL AND CODEINEACTAVIS MID ATLANTICANDA 085883—Approved Prior to Jan 1, 1982
CAPITAL AND CODEINEVALEANT PHARMS LLCANDA 086024—Approved Prior to Jan 1, 1982
ACETAMINOPHEN AND CODEINE PHOSPHATEEVERYLIFEANDA 085217—Approved Prior to Jan 1, 1982
ACETAMINOPHEN AND CODEINE PHOSPHATEHALSEYANDA 083871—Approved Prior to Jan 1, 1982
ACETAMINOPHEN AND CODEINE PHOSPHATEHALSEYANDA 083872—Approved Prior to Jan 1, 1982
ACETAMINOPHEN AND CODEINE PHOSPHATEHALSEYANDA 086549—Approved Prior to Jan 1, 1982
ACETAMINOPHEN AND CODEINE PHOSPHATEKV PHARMANDA 085288—Approved Prior to Jan 1, 1982
ACETAMINOPHEN AND CODEINE PHOSPHATEKV PHARMANDA 085365—Approved Prior to Jan 1, 1982
ACETAMINOPHEN AND CODEINE PHOSPHATEKV PHARMANDA 085364—Approved Prior to Jan 1, 1982
ACETAMINOPHEN AND CODEINE PHOSPHATEKV PHARMANDA 085363—Approved Prior to Jan 1, 1982
ACETAMINOPHEN AND CODEINE PHOSPHATELEDERLEANDA 087141—Approved Prior to Jan 1, 1982
ACETAMINOPHEN AND CODEINE PHOSPHATEMUTUAL PHARMANDA 085795—Approved Prior to Jan 1, 1982
ACETAMINOPHEN AND CODEINE PHOSPHATEMUTUAL PHARMANDA 085794—Approved Prior to Jan 1, 1982
ACETAMINOPHEN AND CODEINE PHOSPHATERLDPUREPAC PHARMANDA 086681—Approved Prior to Jan 1, 1982
ACETAMINOPHEN AND CODEINE PHOSPHATEPUREPAC PHARMANDA 086683—Approved Prior to Jan 1, 1982
ACETAMINOPHEN AND CODEINE PHOSPHATEROXANEANDA 084659—Approved Prior to Jan 1, 1982
ACETAMINOPHEN AND CODEINE PHOSPHATEROXANEANDA 084656—Approved Prior to Jan 1, 1982
ACETAMINOPHEN AND CODEINE PHOSPHATEROXANEANDA 084667—Approved Prior to Jan 1, 1982
ACETAMINOPHEN AND CODEINE PHOSPHATERLDSANDOZANDA 087433—Approved Prior to Jan 1, 1982
ACETAMINOPHEN AND CODEINE PHOSPHATESANDOZANDA 085291—Approved Prior to Jan 1, 1982
ACETAMINOPHEN AND CODEINE PHOSPHATERLDSANDOZANDA 085917—Approved Prior to Jan 1, 1982
ACETAMINOPHEN AND CODEINE PHOSPHATESANDOZANDA 085964—Approved Prior to Jan 1, 1982
ACETAMINOPHEN AND CODEINE PHOSPHATESANDOZANDA 087423—Approved Prior to Jan 1, 1982
ACETAMINOPHEN AND CODEINE PHOSPHATESUN PHARM INDS LTDANDA 085868—Approved Prior to Jan 1, 1982
ACETAMINOPHEN AND CODEINE PHOSPHATESUN PHARM INDS LTDANDA 087083AAApproved Prior to Jan 1, 1982
ACETAMINOPHEN AND CODEINE PHOSPHATEVALEANT PHARM INTLANDA 085896—Approved Prior to Jan 1, 1982
ACETAMINOPHEN AND CODEINE PHOSPHATEVITARINEANDA 085676—Approved Prior to Jan 1, 1982
ACETAMINOPHEN AND CODEINE PHOSPHATEWARNER CHILCOTTANDA 085992—Approved Prior to Jan 1, 1982
ACETAMINOPHEN AND CODEINE PHOSPHATEWARNER CHILCOTTANDA 085218—Approved Prior to Jan 1, 1982
ACETAMINOPHEN AND CODEINE PHOSPHATEWARNER CHILCOTTANDA 087306—Approved Prior to Jan 1, 1982
ACETAMINOPHEN AND CODEINE PHOSPHATEWHITEWORTH TOWN PLSNANDA 084360—Approved Prior to Jan 1, 1982
ACETAMINOPHEN AND CODEINE PHOSPHATEWHITEWORTH TOWN PLSNANDA 085607—Approved Prior to Jan 1, 1982
CAPITAL AND CODEINECARNRICKANDA 083643—Approved Prior to Jan 1, 1982
EMPRACET W/ CODEINE PHOSPHATE #3×2GLAXOSMITHKLINEANDA 083951—Approved Prior to Jan 1, 1982
PHENAPHEN-650 W/ CODEINEROBINS AHANDA 085856—Approved Prior to Jan 1, 1982
TYLENOL W/ CODEINE×4ORTHO MCNEIL PHARMANDA 085056—Approved Prior to Jan 1, 1982
TYLENOL W/ CODEINE NO. 2RLD×4JANSSEN PHARMSANDA 085055—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.

Acetaminophen; codeine phosphate — 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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