homatropine / Hydrocodone Oral Tablet

Brand(s)
Tussigon
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Pfizer Laboratories Div Pfizer Inc (2014-10-06)
Oldest Current Product
1985-07-30
License(s)
ANDA
RxNORM
ORAL TABLET\HOMATROPINE:HYDROCODONE
FDAOB
ORAL\SYRUP\HOMATROPINE METHYLBROMIDE: HYDROCODONE BITARTRATE
ORAL\TABLET\HOMATROPINE METHYLBROMIDE: HYDROCODONE BITARTRATE
SPL Active
ORAL\TABLET\HOMATROPINE METHYLBROMIDE: HYDROCODONE BITARTRATE
SPL Moiety
ORAL\TABLET\HOMATROPINE METHYLBROMIDE: HYDROCODONE: METHYLHOMATROPINE
ORAL\TABLET\HYDROCODONE: METHYLHOMATROPINE

product(s) by strength(s)

homatropine methylbromide 1.5 mg / hydrocodone bitartrate 5 mg oral tablet

generic product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1400320118ANDANovel Laboratories, Inc.2014-09-23HOMATROPINE METHYLBROMIDE, HYDROCODONE BITARTRATEORALTABLETANDA091528b203c87c-1108-4eaa-8a57-87be776d8a70
2433860118ANDAGavis Pharmaceuticals, Llc2014-09-23HOMATROPINE METHYLBROMIDE, HYDROCODONE BITARTRATEORALTABLETANDA09152841ac90b3-f007-4eb2-9d41-ea626ced2017
3615700081TussigonANDAPfizer Laboratories Div Pfizer Inc1985-07-30HOMATROPINE METHYLBROMIDE, HYDROCODONE BITARTRATEORALTABLETANDA08850834961b78-8544-4637-6f8e-0bb7a44a8b2b
4615700102TussigonANDAPfizer Laboratories Div Pfizer Inc1985-07-30HOMATROPINE METHYLBROMIDE, HYDROCODONE BITARTRATEORALTABLETANDA0885086c0bba34-07db-42f5-9e5e-ad79b71b4276

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1663360871ANDADispensing Solutions, Inc.2011-02-16HOMATROPINE METHYLBROMIDE, HYDROCODONE BITARTRATEORALTABLET433860350ANDA0915286df41ed2-4ad2-4500-950e-459e0e76d9c5

application(s)

#idtitledeprecatedapplicantapprovedapproved drugin other drug docs
1ANDA040295HOMATROPRINE METHYLBROMIDE AND HYDROCODONE BITARTRATETrueACTAVIS ELIZABETH LLC2000-12-01ANDA040295_001
2ANDA088508TUSSIGONKING PHARMACEUTICALS RESEARCH AND DEVELOPMENT INC SUB KING PHARMACEUTICALS INC1985-07-30ANDA088508_001
3ANDA091528HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATENOVEL LABORATORIES INC2011-04-20ANDA091528_001
4NDA005213HYCODANTrueENDO PHARMACEUTICALS INC1988-07-26NDA005213_001, NDA005213_002homatropine / Hydrocodone Oral Solution

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA040295_001discontinuedHOMATROPINE METHYLBROMIDE (1.5MG), HYDROCODONE BITARTRATE (5MG)ORALTABLETFalse2000-12-01HOMATROPRINE METHYLBROMIDE AND HYDROCODONE BITARTRATE
2ANDA088508_001RXHYDROCODONE BITARTRATE (5MG), HOMATROPINE METHYLBROMIDE (1.5MG)ORALTABLETTrueAA1985-07-30TUSSIGON
3ANDA091528_001RXHOMATROPINE METHYLBROMIDE (1.5MG), HYDROCODONE BITARTRATE (5MG)ORALTABLETFalseAA2011-04-20HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE
4NDA005213_001discontinuedHYDROCODONE BITARTRATE (5MG), HOMATROPINE METHYLBROMIDE (1.5MG)ORALTABLETFalse1988-07-26HYCODAN
5NDA005213_002discontinuedHOMATROPINE METHYLBROMIDE (1.5MG/5ML), HYDROCODONE BITARTRATE (5MG/5ML)ORALSYRUPFalse1988-07-26HYCODAN

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
134961b78-8544-4637-6f8e-0bb7a44a8b2b (view SPL)TUSSIGON Tablets (Hydrocodone bitartrate and homatropine methylbromide)prescriptionHuman PrescriptionPfizer Laboratories Div Pfizer Inc2014-08-283615700081
241ac90b3-f007-4eb2-9d41-ea626ced2017 (view SPL)Hydrocodone Bitartrate and Homatropine Methylbromide Tablets, USP CIIprescriptionHuman PrescriptionGavis Pharmaceuticals, LlcANALYSIS, MANUFACTURE2014-09-231433860118
36c0bba34-07db-42f5-9e5e-ad79b71b4276 (view SPL)TUSSIGON Tablets (Hydrocodone bitartrate and homatropine methylbromide)prescriptionHuman PrescriptionPfizer Laboratories Div Pfizer Inc2014-10-061615700102
46df41ed2-4ad2-4500-950e-459e0e76d9c5 (view SPL)Hydrocodone Bitartrate and Homatropine Methylbromide Tablets, USPprescriptionHuman PrescriptionDispensing Solutions, Inc.relabel, repack2013-06-252663360871
5b203c87c-1108-4eaa-8a57-87be776d8a70 (view SPL)Hydrocodone Bitartrate and Homatropine Methylbromide Tablets, USP CIIprescriptionHuman PrescriptionNovel Laboratories, Inc.ANALYSIS, MANUFACTURE2014-09-231400320118

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