Acetaminophen / Propoxyphene Oral Tablet

Category(s)
prescription
SPL Type(s)
Human Prescription
Oldest Current Product
2009-01-01
License(s)
ANDA
RxNORM
ORAL TABLET\ACETAMINOPHEN:PROPOXYPHENE
FDAOB
ORAL\TABLET\ACETAMINOPHEN: PROPOXYPHENE HYDROCHLORIDE
ORAL\TABLET\ACETAMINOPHEN: PROPOXYPHENE NAPSYLATE
SPL Active
ORAL\TABLET, FILM COATED\ACETAMINOPHEN: PROPOXYPHENE HYDROCHLORIDE
ORAL\TABLET, FILM COATED\ACETAMINOPHEN: PROPOXYPHENE NAPSYLATE
ORAL\TABLET\ACETAMINOPHEN: PROPOXYPHENE NAPSYLATE
SPL Moiety
ORAL\TABLET, FILM COATED\ACETAMINOPHEN: PROPOXYPHENE
ORAL\TABLET\ACETAMINOPHEN: PROPOXYPHENE

product(s) by strength(s)

invalid application product(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1003780130ANDAMylan Pharmaceuticals Inc.2009-11-30ACETAMINOPHEN, PROPOXYPHENE HYDROCHLORIDEORALTABLET, FILM COATEDANDA083978b66b68ce-fa1f-4d7d-9700-eee30eca3837

invalid application product(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1126340537ANDAApotheca, Inc2009-01-01ACETAMINOPHEN, PROPOXYPHENE NAPSYLATEORALTABLET, FILM COATED000930890ANDA074119f2bc3c76-fd41-4a79-aa5d-3eb45133c1ee
2216950280ANDARebel Distributors Corp2009-12-01ACETAMINOPHEN, PROPOXYPHENE NAPSYLATEORALTABLET, FILM COATED000930890ANDA07411948237a1b-a9e3-4123-a041-a49eeca8d84c
3493490159ANDARemedyrepack Inc.2011-02-15ACETAMINOPHEN, PROPOXYPHENE NAPSYLATEORALTABLET00406177210ANDA07573815f3fea9-fc86-4065-b01e-4e26eafa2607
4499990767ANDALake Erie Medical Dba Quality Care Products Llc2011-01-25ACETAMINOPHEN, PROPOXYPHENE NAPSYLATEORALTABLET, FILM COATED000930890ANDA0741192e106abb-8b1d-4d83-8b42-fc46cfde113e
5636291344ANDABryant Ranch Prepack2009-11-04ACETAMINOPHEN, PROPOXYPHENE NAPSYLATEORALTABLET, FILM COATED003780155ANDA070145a8f31163-264b-4209-aef9-f60202ad9264
6638740201ANDAAltura Pharmaceuticals, Inc.2010-01-01ACETAMINOPHEN, PROPOXYPHENE NAPSYLATEORALTABLET, FILM COATED006035468ANDA0748432eb7266d-1d31-4cdc-96f5-987bb8373cc9
7672960104ANDARedpharm Drug Inc.2009-06-08ACETAMINOPHEN, PROPOXYPHENE NAPSYLATEORALTABLET004061721ANDA07573809e1e32d-1874-40d7-8829-52b3a489d9fd
8672960105ANDARedpharm Drug Inc.2009-06-08ACETAMINOPHEN, PROPOXYPHENE NAPSYLATEORALTABLET004061772ANDA075738aaccfdf4-ce07-4799-9a7c-14dc0588a2a3
9672960378ANDARedpharm Drug Inc.2009-11-25ACETAMINOPHEN, PROPOXYPHENE NAPSYLATEORALTABLET, FILM COATED000930490ANDA0741193b3adfad-5f99-4add-bcdc-069d0a0da418
10683870100ANDAKeltman Pharmaceuticals Inc.2009-03-01ACETAMINOPHEN, PROPOXYPHENE NAPSYLATEORALTABLET, FILM COATED006035468ANDA0748436ce33ae0-8f55-4d74-9c1e-003be1001596

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA040139PROPOXYPHENE HYDROCHLORIDE AND ACETAMINOPHENTrueWATSON LABORATORIES INC1996-12-16ANDA040139_001
2ANDA040507PROPOXYPHENE HYDROCHLORIDE AND ACETAMINOPHENTrueVINTAGE PHARMACEUTICALS INC2003-07-30ANDA040507_001
3ANDA070107PROPACET 100TrueTEVA PHARMACEUTICALS USA INC1985-06-12ANDA070107_001
4ANDA070115PROPOXYPHENE NAPSYLATE AND ACETAMINOPHENTrueMUTUAL PHARMACEUTICAL CO INC1985-06-12ANDA070115_001
5ANDA070116PROPOXYPHENE NAPSYLATE AND ACETAMINOPHENTrueMUTUAL PHARMACEUTICAL CO INC1985-06-12ANDA070116_001
6ANDA070145PROPOXYPHENE NAPSYLATE AND ACETAMINOPHENTrueMYLAN PHARMACEUTICALS INC1985-06-12ANDA070145_001
7ANDA070146PROPOXYPHENE NAPSYLATE AND ACETAMINOPHENTrueIVAX PHARMACEUTICALS INC SUB TEVA PHARMACEUTICALS USA1985-08-02ANDA070146_001
8ANDA070398PROPOXYPHENE NAPSYLATE AND ACETAMINOPHENTrueWATSON LABORATORIES INC1986-12-18ANDA070398_001
9ANDA070399PROPOXYPHENE NAPSYLATE AND ACETAMINOPHENTrueWATSON LABORATORIES INC1986-12-18ANDA070399_001
10ANDA070443PROPOXYPHENE NAPSYLATE AND ACETAMINOPHENTrueSANDOZ INC1986-01-23ANDA070443_001
11ANDA070615PROPOXYPHENE NAPSYLATE AND ACETAMINOPHENTrueMUTUAL PHARMACEUTICAL CO INC1986-03-21ANDA070615_001
12ANDA070732PROPOXYPHENE NAPSYLATE AND ACETAMINOPHENTrueTEVA PHARMACEUTICALS USA INC1986-01-03ANDA070732_001
13ANDA070771PROPOXYPHENE NAPSYLATE AND ACETAMINOPHENTrueMUTUAL PHARMACEUTICAL CO INC1986-03-21ANDA070771_001
14ANDA070775PROPOXYPHENE NAPSYLATE AND ACETAMINOPHENTrueMUTUAL PHARMACEUTICAL CO INC1986-03-21ANDA070775_001
15ANDA070910PROPOXYPHENE NAPSYLATE AND ACETAMINOPHENTrueACTAVIS ELIZABETH LLC1987-01-02ANDA070910_001
16ANDA071319PROPOXYPHENE NAPSYLATE AND ACETAMINOPHENTrueSUPERPHARM CORP1987-01-06ANDA071319_001
17ANDA072105PROPOXYPHENE NAPSYLATE AND ACETAMINOPHENTrueHALSEY DRUG CO INC1988-05-13ANDA072105_001
18ANDA072106PROPOXYPHENE NAPSYLATE AND ACETAMINOPHENTrueHALSEY DRUG CO INC1988-05-13ANDA072106_001
19ANDA072195PROPOXYPHENE NAPSYLATE AND ACETAMINOPHENTrueMYLAN PHARMACEUTICALS INC1988-02-16ANDA072195_001
20ANDA074119PROPOXYPHENE NAPSYLATE AND ACETAMINOPHENTrueTEVA PHARMACEUTICALS USA INC1994-12-19ANDA074119_001
21ANDA074843PROPOXYPHENE NAPSYLATE AND ACETAMINOPHENTrueVINTAGE PHARMACEUTICALS INC1997-02-12ANDA074843_001, ANDA074843_002
22ANDA075738PROPOXYPHENE NAPSYLATE AND ACETAMINOPHENTrueMALLINCKRODT INC2001-02-02ANDA075738_001
23ANDA075838PROPOXYPHENE NAPSYLATE AND ACETAMINOPHENTrueABLE LABORATORIES INC2001-07-11ANDA075838_001
24ANDA076429DARVOCET A500TrueXANODYNE PHARMACEUTICS INC2003-09-10ANDA076429_001
25ANDA076609PROPOXYPHENE NAPSYLATE AND ACETAMINOPHENTrueWATSON LABORATORIES INC FLORIDA2004-11-16ANDA076609_001
26ANDA076743PROPOXYPHENE NAPSYLATE AND ACETAMINOPHENTrueCORNERSTONE BIOPHARMA INC2004-05-07ANDA076743_001
27ANDA076750PROPOXYPHENE NAPSYLATE AND ACETAMINOPHENTrueCORNERSTONE BIOPHARMA INC2004-06-28ANDA076750_001
28ANDA077196PROPOXYPHENE NAPSYLATE AND ACETAMINOPHENTrueWATSON LABORATORIES INC FLORIDA2005-06-28ANDA077196_001
29ANDA077677PROPOXYPHENE NAPSYLATE AND ACETAMINOPHENTrueWOCKHARDT LTD2007-03-16ANDA077677_001, ANDA077677_002
30ANDA077821PROPOXYPHENE NAPSYLATE AND ACETAMINOPHENTrueMIRROR PHARMACEUTICALS LLC2008-02-11ANDA077821_001
31ANDA083689PROPOXYPHENE HYDROCHLORIDE AND ACETAMINOPHENTrueMYLAN PHARMACEUTICALS INCANDA083689_001
32ANDA083978PROPOXYPHENE HYDROCHLORIDE AND ACETAMINOPHENTrueMYLAN PHARMACEUTICALS INCANDA083978_001
33ANDA084999WYGESICTrueCARACO PHARMACEUTICAL LABORATORIES LTDANDA084999_001
34ANDA085100DOLENE AP-65TrueLEDERLE LABORATORIES DIV AMERICAN CYANAMID COANDA085100_001
35ANDA089959PROPOXYPHENE HYDROCHLORIDE AND ACETAMINOPHENTrueSANDOZ INC1989-07-18ANDA089959_001
36NDA016844DARVOCETTrueAAIPHARMA LLCNDA016844_001
37NDA017122DARVOCET-N 100TrueXANODYNE PHARMACEUTICS INCNDA017122_001, NDA017122_002

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1ANDA040139_001discontinuedPROPOXYPHENE HYDROCHLORIDE (65MG), ACETAMINOPHEN (650MG)ORALTABLETFalse1996-12-16PROPOXYPHENE HYDROCHLORIDE AND ACETAMINOPHEN
2ANDA040507_001discontinuedACETAMINOPHEN (650MG), PROPOXYPHENE HYDROCHLORIDE (65MG)ORALTABLETFalse2003-07-30PROPOXYPHENE HYDROCHLORIDE AND ACETAMINOPHEN
3ANDA070107_001discontinuedPROPOXYPHENE NAPSYLATE (100MG), ACETAMINOPHEN (650MG)ORALTABLETFalse1985-06-12PROPACET 100
4ANDA070115_001discontinuedACETAMINOPHEN (325MG), PROPOXYPHENE NAPSYLATE (50MG)ORALTABLETFalse1985-06-12PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN
5ANDA070116_001discontinuedACETAMINOPHEN (650MG), PROPOXYPHENE NAPSYLATE (100MG)ORALTABLETFalse1985-06-12PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN
6ANDA070145_001discontinuedACETAMINOPHEN (650MG), PROPOXYPHENE NAPSYLATE (100MG)ORALTABLETFalse1985-06-12PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN
7ANDA070146_001discontinuedACETAMINOPHEN (650MG), PROPOXYPHENE NAPSYLATE (100MG)ORALTABLETFalse1985-08-02PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN
8ANDA070398_001discontinuedPROPOXYPHENE NAPSYLATE (50MG), ACETAMINOPHEN (325MG)ORALTABLETFalse1986-12-18PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN
9ANDA070399_001discontinuedPROPOXYPHENE NAPSYLATE (100MG), ACETAMINOPHEN (650MG)ORALTABLETFalse1986-12-18PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN
10ANDA070443_001discontinuedACETAMINOPHEN (650MG), PROPOXYPHENE NAPSYLATE (100MG)ORALTABLETFalse1986-01-23PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN
11ANDA070615_001discontinuedACETAMINOPHEN (650MG), PROPOXYPHENE NAPSYLATE (100MG)ORALTABLETFalse1986-03-21PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN
12ANDA070732_001discontinuedPROPOXYPHENE NAPSYLATE (100MG), ACETAMINOPHEN (650MG)ORALTABLETFalse1986-01-03PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN
13ANDA070771_001discontinuedACETAMINOPHEN (650MG), PROPOXYPHENE NAPSYLATE (100MG)ORALTABLETFalse1986-03-21PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN
14ANDA070775_001discontinuedPROPOXYPHENE NAPSYLATE (100MG), ACETAMINOPHEN (650MG)ORALTABLETFalse1986-03-21PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN
15ANDA070910_001discontinuedPROPOXYPHENE NAPSYLATE (100MG), ACETAMINOPHEN (650MG)ORALTABLETFalse1987-01-02PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN
16ANDA071319_001discontinuedACETAMINOPHEN (650MG), PROPOXYPHENE NAPSYLATE (100MG)ORALTABLETFalse1987-01-06PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN
17ANDA072105_001discontinuedACETAMINOPHEN (325MG), PROPOXYPHENE NAPSYLATE (50MG)ORALTABLETFalse1988-05-13PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN
18ANDA072106_001discontinuedPROPOXYPHENE NAPSYLATE (100MG), ACETAMINOPHEN (650MG)ORALTABLETFalse1988-05-13PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN
19ANDA072195_001discontinuedPROPOXYPHENE NAPSYLATE (100MG), ACETAMINOPHEN (650MG)ORALTABLETFalse1988-02-16PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN
20ANDA074119_001discontinuedPROPOXYPHENE NAPSYLATE (100MG), ACETAMINOPHEN (650MG)ORALTABLETFalse1994-12-19PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN
21ANDA074843_001discontinuedPROPOXYPHENE NAPSYLATE (100MG), ACETAMINOPHEN (650MG)ORALTABLETFalse1997-02-12PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN
22ANDA074843_002discontinuedACETAMINOPHEN (325MG), PROPOXYPHENE NAPSYLATE (50MG)ORALTABLETFalse2001-02-15PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN
23ANDA075738_001discontinuedACETAMINOPHEN (650MG), PROPOXYPHENE NAPSYLATE (100MG)ORALTABLETFalse2001-02-02PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN
24ANDA075838_001discontinuedPROPOXYPHENE NAPSYLATE (100MG), ACETAMINOPHEN (650MG)ORALTABLETFalse2001-07-11PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN
25ANDA076429_001discontinuedPROPOXYPHENE NAPSYLATE (100MG), ACETAMINOPHEN (500MG)ORALTABLETFalse2003-09-10DARVOCET A500
26ANDA076609_001discontinuedPROPOXYPHENE NAPSYLATE (100MG), ACETAMINOPHEN (650MG)ORALTABLETFalse2004-11-16PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN
27ANDA076743_001discontinuedACETAMINOPHEN (325MG), PROPOXYPHENE NAPSYLATE (100MG)ORALTABLETFalse2004-05-07PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN
28ANDA076750_001discontinuedACETAMINOPHEN (500MG), PROPOXYPHENE NAPSYLATE (100MG)ORALTABLETFalse2004-06-28PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN
29ANDA077196_001discontinuedPROPOXYPHENE NAPSYLATE (100MG), ACETAMINOPHEN (500MG)ORALTABLETFalse2005-06-28PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN
30ANDA077677_001discontinuedACETAMINOPHEN (325MG), PROPOXYPHENE NAPSYLATE (50MG)ORALTABLETFalse2007-03-16PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN
31ANDA077677_002discontinuedPROPOXYPHENE NAPSYLATE (100MG), ACETAMINOPHEN (650MG)ORALTABLETFalse2007-03-16PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN
32ANDA077821_001discontinuedPROPOXYPHENE NAPSYLATE (100MG), ACETAMINOPHEN (650MG)ORALTABLETFalse2008-02-11PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN
33ANDA083689_001discontinuedACETAMINOPHEN (325MG), PROPOXYPHENE HYDROCHLORIDE (32MG)ORALTABLETFalsePROPOXYPHENE HYDROCHLORIDE AND ACETAMINOPHEN
34ANDA083978_001discontinuedPROPOXYPHENE HYDROCHLORIDE (65MG), ACETAMINOPHEN (650MG)ORALTABLETFalsePROPOXYPHENE HYDROCHLORIDE AND ACETAMINOPHEN
35ANDA084999_001discontinuedPROPOXYPHENE HYDROCHLORIDE (65MG), ACETAMINOPHEN (650MG)ORALTABLETFalseWYGESIC
36ANDA085100_001discontinuedPROPOXYPHENE HYDROCHLORIDE (65MG), ACETAMINOPHEN (650MG)ORALTABLETFalseDOLENE AP-65
37ANDA089959_001discontinuedPROPOXYPHENE HYDROCHLORIDE (65MG), ACETAMINOPHEN (650MG)ORALTABLETFalse1989-07-18PROPOXYPHENE HYDROCHLORIDE AND ACETAMINOPHEN
38NDA016844_001discontinuedACETAMINOPHEN (325MG), PROPOXYPHENE HYDROCHLORIDE (32.5MG)ORALTABLETFalseDARVOCET
39NDA017122_001discontinuedACETAMINOPHEN (325MG), PROPOXYPHENE NAPSYLATE (50MG)ORALTABLETFalseDARVOCET-N 100
40NDA017122_002discontinuedPROPOXYPHENE NAPSYLATE (100MG), ACETAMINOPHEN (650MG)ORALTABLETFalseDARVOCET-N 100

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
109e1e32d-1874-40d7-8829-52b3a489d9fd (view SPL)Propoxyphene Napsylate and Acetaminophen TabletsprescriptionHuman PrescriptionRedpharm Drug Inc.analysis, manufacture2011-06-201672960104
215f3fea9-fc86-4065-b01e-4e26eafa2607 (view SPL)prescriptionHuman PrescriptionRemedyrepack Inc.2011-02-151493490159
32e106abb-8b1d-4d83-8b42-fc46cfde113e (view SPL)PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN TABLETS, USP 100 mg/650 mg CIV04900890Rx onlyprescriptionHuman PrescriptionLake Erie Medical Dba Quality Care Products Llcmanufacture, repack2011-12-013285499990767
42eb7266d-1d31-4cdc-96f5-987bb8373cc9 (view SPL)PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN TABLETS, USP50 mg/325 mg and 100 mg/650 mg CIV Rx onlyprescriptionHuman PrescriptionAltura Pharmaceuticals, Inc.relabel, repack2010-04-281638740201
53b3adfad-5f99-4add-bcdc-069d0a0da418 (view SPL)PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN TABLETS, USP 100 mg/650 mg CIV04900890Rx onlyprescriptionHuman PrescriptionRedpharm Drug Inc.manufacture2011-05-255672960378
648237a1b-a9e3-4123-a041-a49eeca8d84c (view SPL)PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN TABLETS, USP 100 mg/650 mg CIV04900890Rx onlyprescriptionHuman PrescriptionRebel Distributors Corprelabel, repack2009-12-011216950280
76ce33ae0-8f55-4d74-9c1e-003be1001596 (view SPL)PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN TABLETS, USP50 mg/325 mg and 100 mg/650 mg CIV Rx onlyprescriptionHuman PrescriptionKeltman Pharmaceuticals Inc.repack2010-08-031683870100
8a8f31163-264b-4209-aef9-f60202ad9264 (view SPL)prescriptionHuman PrescriptionBryant Ranch PrepackRELABEL, REPACK2009-10-201636291344
9aaccfdf4-ce07-4799-9a7c-14dc0588a2a3 (view SPL)Propoxyphene Napsylate and Acetaminophen TabletsprescriptionHuman PrescriptionRedpharm Drug Inc.analysis, manufacture2011-06-201672960105
10b66b68ce-fa1f-4d7d-9700-eee30eca3837 (view SPL)prescriptionHuman PrescriptionMylan Pharmaceuticals Inc.2009-10-202003780130
11f2bc3c76-fd41-4a79-aa5d-3eb45133c1ee (view SPL)PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN TABLET USP 100MG/650MG CS-CIVprescriptionHuman PrescriptionApotheca, Increlabel, repack2010-03-111126340537

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII