Protriptyline Oral Tablet

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Epic Pharma, Llc (2014-07-23)
Oldest Current Product
2008-09-16
License(s)
ANDA
RxNORM
ORAL TABLET\PROTRIPTYLINE
FDAOB
ORAL\TABLET\PROTRIPTYLINE HYDROCHLORIDE
SPL Active
ORAL\TABLET, FILM COATED\PROTRIPTYLINE HYDROCHLORIDE
ORAL\TABLET\PROTRIPTYLINE HYDROCHLORIDE
SPL Moiety
ORAL\TABLET, FILM COATED\PROTRIPTYLINE
ORAL\TABLET\PROTRIPTYLINE

product(s) by strength(s)

protriptyline hydrochloride 10 mg oral tablet

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000540211ANDARoxane Laboratories, Inc2008-09-16PROTRIPTYLINE HYDROCHLORIDEORALTABLETANDA078913700abc58-9362-4ef5-9d7a-dd3c4d364d0a
2428060097ANDAEpic Pharma, Llc2013-01-09PROTRIPTYLINE HYDROCHLORIDEORALTABLET, FILM COATEDANDA202220c6c7c39e-e510-4f4a-bf7a-926f0e075d3a
3503830960ANDAHi-Tech Pharmacal Co., Inc.2013-10-28PROTRIPTYLINE HYDROCHLORIDEORALTABLET, FILM COATEDANDA2022209a773f26-2d86-4b5e-abfa-ef5718c8184b
4649800159ANDARising Pharmaceuticals, Inc.2010-06-11PROTRIPTYLINE HYDROCHLORIDEORALTABLET, FILM COATEDANDA090462b8881a81-75d7-43e8-825f-37c352c146dc

protriptyline hydrochloride 5 mg oral tablet

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000540210ANDARoxane Laboratories, Inc2008-09-16PROTRIPTYLINE HYDROCHLORIDEORALTABLETANDA078913700abc58-9362-4ef5-9d7a-dd3c4d364d0a
2428060096ANDAEpic Pharma, Llc2013-01-09PROTRIPTYLINE HYDROCHLORIDEORALTABLET, FILM COATEDANDA202220c6c7c39e-e510-4f4a-bf7a-926f0e075d3a
3503830959ANDAHi-Tech Pharmacal Co., Inc.2013-10-28PROTRIPTYLINE HYDROCHLORIDEORALTABLET, FILM COATEDANDA2022209a773f26-2d86-4b5e-abfa-ef5718c8184b
4649800158ANDARising Pharmaceuticals, Inc.2010-06-11PROTRIPTYLINE HYDROCHLORIDEORALTABLET, FILM COATEDANDA090462b8881a81-75d7-43e8-825f-37c352c146dc

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA073644VIVACTILODYSSEY PHARMACEUTICALS INC1995-08-24ANDA073644_001
2ANDA073645VIVACTILODYSSEY PHARMACEUTICALS INC1995-08-24ANDA073645_001
3ANDA078913PROTRIPTYLINE HYDROCHLORIDEROXANE LABORATORIES INC2008-09-16ANDA078913_001, ANDA078913_002
4ANDA090462PROTRIPTYLINE HYDROCHLORIDESIGMAPHARM LABORATORIES LLC2010-05-03ANDA090462_001, ANDA090462_002
5ANDA202220PROTRIPTYLINE HYDROCHLORIDEEPIC PHARMA LLC2012-11-19ANDA202220_001, ANDA202220_002
6NDA016012VIVACTILTrueTEVA WOMENS HEALTH INCNDA016012_001, NDA016012_002

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA073644_001RXPROTRIPTYLINE HYDROCHLORIDE (5MG)ORALTABLETFalseAB1995-08-24VIVACTIL
2ANDA073645_001RXPROTRIPTYLINE HYDROCHLORIDE (10MG)ORALTABLETTrueAB1995-08-24VIVACTIL
3ANDA078913_001RXPROTRIPTYLINE HYDROCHLORIDE (5MG)ORALTABLETFalseAB2008-09-16PROTRIPTYLINE HYDROCHLORIDE
4ANDA078913_002RXPROTRIPTYLINE HYDROCHLORIDE (10MG)ORALTABLETFalseAB2008-09-16PROTRIPTYLINE HYDROCHLORIDE
5ANDA090462_001RXPROTRIPTYLINE HYDROCHLORIDE (5MG)ORALTABLETFalseAB2010-05-03PROTRIPTYLINE HYDROCHLORIDE
6ANDA090462_002RXPROTRIPTYLINE HYDROCHLORIDE (10MG)ORALTABLETFalseAB2010-05-03PROTRIPTYLINE HYDROCHLORIDE
7ANDA202220_001RXPROTRIPTYLINE HYDROCHLORIDE (5MG)ORALTABLETFalseAB2012-11-19PROTRIPTYLINE HYDROCHLORIDE
8ANDA202220_002RXPROTRIPTYLINE HYDROCHLORIDE (10MG)ORALTABLETFalseAB2012-11-19PROTRIPTYLINE HYDROCHLORIDE
9NDA016012_001discontinuedPROTRIPTYLINE HYDROCHLORIDE (5MG)ORALTABLETFalseVIVACTIL
10NDA016012_002discontinuedPROTRIPTYLINE HYDROCHLORIDE (10MG)ORALTABLETFalseVIVACTIL

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1700abc58-9362-4ef5-9d7a-dd3c4d364d0a (view SPL)Protriptyline Hydrochloride Tablets, USPprescriptionHuman PrescriptionRoxane Laboratories, IncMANUFACTURE2014-05-233000540210, 000540211
29a773f26-2d86-4b5e-abfa-ef5718c8184b (view SPL)Protriptyline Hydrochloride Tablets, USPprescriptionHuman PrescriptionHi-Tech Pharmacal Co., Inc.MANUFACTURE2013-09-251503830959, 503830960
3b8881a81-75d7-43e8-825f-37c352c146dc (view SPL)Protriptyline HCl Tablets, USPprescriptionHuman PrescriptionRising Pharmaceuticals, Inc.analysis, manufacture, pack2015-08-045649800158, 649800159
4c6c7c39e-e510-4f4a-bf7a-926f0e075d3a (view SPL)Protriptyline Hydrochloride Tablets, USPRx OnlyprescriptionHuman PrescriptionEpic Pharma, LlcMANUFACTURE2014-07-235428060096, 428060097

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