Acetaminophen / Pentazocine Oral Tablet

Category(s)
prescription
SPL Type(s)
Human Prescription
Oldest Current Product
2000-03-24
License(s)
ANDA
RxNORM
ORAL TABLET\ACETAMINOPHEN:PENTAZOCINE
FDAOB
ORAL\TABLET\ACETAMINOPHEN: PENTAZOCINE HYDROCHLORIDE
SPL Active
ORAL\TABLET\ACETAMINOPHEN: PENTAZOCINE HYDROCHLORIDE
SPL Moiety
ORAL\TABLET\ACETAMINOPHEN: PENTAZOCINE

product(s) by strength(s)

invalid application product(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1216950634ANDARebel Distributors Corp2000-03-24ACETAMINOPHEN, PENTAZOCINE HYDROCHLORIDEORALTABLET005910396ANDA074699fbb6a064-59a6-4e1c-bbb6-5934c1505c4f
2433860670ANDAGavis Pharmaceuticals, Llc2011-05-11ACETAMINOPHEN, PENTAZOCINE HYDROCHLORIDEORALTABLETANDA07620262a055f3-a58b-446d-9476-af6d36956eaf

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA074699ACETAMINOPHEN AND PENTAZOCINE HYDROCHLORIDETrueWATSON LABORATORIES2000-03-24ANDA074699_001
2ANDA076202ACETAMINOPHEN AND PENTAZOCINE HYDROCHLORIDETrueGAVIS PHARMACEUTICALS LLC2002-08-02ANDA076202_001
3NDA018458TALACENTrueSANOFI AVENTIS US LLC1982-09-23NDA018458_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1ANDA074699_001discontinuedACETAMINOPHEN (650MG), PENTAZOCINE HYDROCHLORIDE (EQ 25MG BASE)ORALTABLETFalse2000-03-24ACETAMINOPHEN AND PENTAZOCINE HYDROCHLORIDE
2ANDA076202_001discontinuedACETAMINOPHEN (650MG), PENTAZOCINE HYDROCHLORIDE (EQ 25MG BASE)ORALTABLETFalse2002-08-02ACETAMINOPHEN AND PENTAZOCINE HYDROCHLORIDE
3NDA018458_001discontinuedACETAMINOPHEN (650MG), PENTAZOCINE HYDROCHLORIDE (EQ 25MG BASE)ORALTABLETFalse1982-09-23TALACEN

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
162a055f3-a58b-446d-9476-af6d36956eaf (view SPL)Pentazocine Hydrochloride and Acetaminophen TabletsprescriptionHuman PrescriptionGavis Pharmaceuticals, LlcMANUFACTURE2011-07-121433860670
2fbb6a064-59a6-4e1c-bbb6-5934c1505c4f (view SPL)Pentazocine HCl and Acetaminophen Tablets C-IV Rx only 30276-4prescriptionHuman PrescriptionRebel Distributors CorpRELABEL, REPACK2010-11-101216950634

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