Amitriptyline / Chlordiazepoxide Oral Tablet

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Mylan Pharmaceuticals Inc. (2014-12-23)
Oldest Current Product
1986-12-10
License(s)
ANDA
RxNORM
ORAL TABLET\AMITRIPTYLINE:CHLORDIAZEPOXIDE
FDAOB
ORAL\TABLET\AMITRIPTYLINE HYDROCHLORIDE: CHLORDIAZEPOXIDE
SPL Active
ORAL\TABLET, FILM COATED\AMITRIPTYLINE HYDROCHLORIDE: CHLORDIAZEPOXIDE
ORAL\TABLET\AMITRIPTYLINE HYDROCHLORIDE: CHLORDIAZEPOXIDE
SPL Moiety
ORAL\TABLET, FILM COATED\AMITRIPTYLINE: CHLORDIAZEPOXIDE
ORAL\TABLET\AMITRIPTYLINE: CHLORDIAZEPOXIDE

product(s) by strength(s)

amitriptyline hydrochloride 12.5 mg / chlordiazepoxide 5 mg oral tablet

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1003780211ANDAMylan Pharmaceuticals Inc.1986-12-10AMITRIPTYLINE HYDROCHLORIDE, CHLORDIAZEPOXIDEORALTABLET, FILM COATEDANDA07129766a756f2-ac77-451c-a19a-08896d73b15c

invalid application product(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1498840265ANDAPar Pharmaceutical Companies, Inc.1988-05-09AMITRIPTYLINE HYDROCHLORIDE, CHLORDIAZEPOXIDEORALTABLETANDA07227722d710ec-302a-4756-95e3-8ee7957586e4

amitriptyline hydrochloride 25 mg / chlordiazepoxide 10 mg oral tablet

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1003780277ANDAMylan Pharmaceuticals Inc.1986-12-10AMITRIPTYLINE HYDROCHLORIDE, CHLORDIAZEPOXIDEORALTABLET, FILM COATEDANDA07129766a756f2-ac77-451c-a19a-08896d73b15c

invalid application product(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1498840266ANDAPar Pharmaceutical Companies, Inc.1988-05-09AMITRIPTYLINE HYDROCHLORIDE, CHLORDIAZEPOXIDEORALTABLETANDA07227822d710ec-302a-4756-95e3-8ee7957586e4

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA070477CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDETrueUSL PHARMA INC1988-01-12ANDA070477_001
2ANDA070478CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDETrueUSL PHARMA INC1988-01-12ANDA070478_001
3ANDA070765CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDETrueMUTUAL PHARMACEUTICAL CO INC1986-12-10ANDA070765_001
4ANDA070766CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDETrueMUTUAL PHARMACEUTICAL CO INC1986-12-10ANDA070766_001
5ANDA071297CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDEMYLAN PHARMACEUTICALS INC1986-12-10ANDA071297_001, ANDA071297_002
6ANDA072052CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDETrueWATSON LABORATORIES INC1988-12-16ANDA072052_001
7ANDA072053CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDETrueWATSON LABORATORIES INC1988-12-16ANDA072053_001
8ANDA072277CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDETruePAR PHARMACEUTICAL INC1988-05-09ANDA072277_001
9ANDA072278CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDETruePAR PHARMACEUTICAL INC1988-05-09ANDA072278_001
10NDA016949LIMBITROLTrueHERITAGE PHARMACEUTICALS INCNDA016949_001, NDA016949_002

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1ANDA070477_001discontinuedCHLORDIAZEPOXIDE (5MG), AMITRIPTYLINE HYDROCHLORIDE (EQ 12.5MG BASE)ORALTABLETFalse1988-01-12CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE
2ANDA070478_001discontinuedCHLORDIAZEPOXIDE (10MG), AMITRIPTYLINE HYDROCHLORIDE (EQ 25MG BASE)ORALTABLETFalse1988-01-12CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE
3ANDA070765_001discontinuedAMITRIPTYLINE HYDROCHLORIDE (EQ 12.5MG BASE), CHLORDIAZEPOXIDE (5MG)ORALTABLETFalse1986-12-10CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE
4ANDA070766_001discontinuedAMITRIPTYLINE HYDROCHLORIDE (EQ 25MG BASE), CHLORDIAZEPOXIDE (10MG)ORALTABLETFalse1986-12-10CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE
5ANDA071297_001RXCHLORDIAZEPOXIDE (10MG), AMITRIPTYLINE HYDROCHLORIDE (EQ 25MG BASE)ORALTABLETTrue1986-12-10CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE
6ANDA071297_002RXCHLORDIAZEPOXIDE (5MG), AMITRIPTYLINE HYDROCHLORIDE (EQ 12.5MG BASE)ORALTABLETFalse1986-12-10CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE
7ANDA072052_001discontinuedCHLORDIAZEPOXIDE (5MG), AMITRIPTYLINE HYDROCHLORIDE (EQ 12.5MG BASE)ORALTABLETFalse1988-12-16CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE
8ANDA072053_001discontinuedAMITRIPTYLINE HYDROCHLORIDE (EQ 25MG BASE), CHLORDIAZEPOXIDE (10MG)ORALTABLETFalse1988-12-16CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE
9ANDA072277_001discontinuedAMITRIPTYLINE HYDROCHLORIDE (EQ 12.5MG BASE), CHLORDIAZEPOXIDE (5MG)ORALTABLETFalse1988-05-09CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE
10ANDA072278_001discontinuedAMITRIPTYLINE HYDROCHLORIDE (EQ 25MG BASE), CHLORDIAZEPOXIDE (10MG)ORALTABLETFalse1988-05-09CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE
11NDA016949_001discontinuedAMITRIPTYLINE HYDROCHLORIDE (EQ 12.5MG BASE), CHLORDIAZEPOXIDE (5MG)ORALTABLETFalseLIMBITROL
12NDA016949_002discontinuedAMITRIPTYLINE HYDROCHLORIDE (EQ 25MG BASE), CHLORDIAZEPOXIDE (10MG)ORALTABLETFalseLIMBITROL

spl(s)

#idtitlecategorytypelabelerlast updateversionproduct(s)
122d710ec-302a-4756-95e3-8ee7957586e4 (view SPL)prescriptionHuman PrescriptionPar Pharmaceutical Companies, Inc.2012-06-134498840265, 498840266
266a756f2-ac77-451c-a19a-08896d73b15c (view SPL)prescriptionHuman PrescriptionMylan Pharmaceuticals Inc.2014-12-237003780211, 003780277

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