Maprotiline Oral Tablet

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Mylan Pharmaceuticals Inc. (2014-12-25)
Oldest Current Product
1988-10-03
License(s)
ANDA
RxNORM
ORAL TABLET\MAPROTILINE
FDAOB
ORAL\TABLET\MAPROTILINE HYDROCHLORIDE
SPL Active
ORAL\TABLET, FILM COATED\MAPROTILINE HYDROCHLORIDE
SPL Moiety
ORAL\TABLET, FILM COATED\MAPROTILINE

product(s) by strength(s)

maprotiline hydrochloride 25 mg oral tablet

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1003780060ANDAMylan Pharmaceuticals Inc.1988-10-03MAPROTILINE HYDROCHLORIDEORALTABLET, FILM COATEDANDA072285c3ca69e6-1ea0-4c2c-abcb-7264b2e79a87

maprotiline hydrochloride 50 mg oral tablet

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1003780087ANDAMylan Pharmaceuticals Inc.1988-10-03MAPROTILINE HYDROCHLORIDEORALTABLET, FILM COATEDANDA072285c3ca69e6-1ea0-4c2c-abcb-7264b2e79a87

maprotiline hydrochloride 75 mg oral tablet

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1003780092ANDAMylan Pharmaceuticals Inc.1988-10-03MAPROTILINE HYDROCHLORIDEORALTABLET, FILM COATEDANDA072285c3ca69e6-1ea0-4c2c-abcb-7264b2e79a87

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA071943MAPROTILINE HYDROCHLORIDETrueWATSON LABORATORIES INC1987-12-30ANDA071943_001
2ANDA071944MAPROTILINE HYDROCHLORIDETrueWATSON LABORATORIES INC1987-12-30ANDA071944_001
3ANDA071945MAPROTILINE HYDROCHLORIDETrueWATSON LABORATORIES INC1987-12-30ANDA071945_001
4ANDA072129MAPROTILINE HYDROCHLORIDETrueAMERICAN THERAPEUTICS INC1988-01-14ANDA072129_001
5ANDA072130MAPROTILINE HYDROCHLORIDETrueAMERICAN THERAPEUTICS INC1988-01-14ANDA072130_001
6ANDA072131MAPROTILINE HYDROCHLORIDETrueAMERICAN THERAPEUTICS INC1988-01-14ANDA072131_001
7ANDA072162MAPROTILINE HYDROCHLORIDETrueWATSON LABORATORIES INC1988-06-01ANDA072162_001
8ANDA072163MAPROTILINE HYDROCHLORIDETrueWATSON LABORATORIES INC1988-06-01ANDA072163_001
9ANDA072164MAPROTILINE HYDROCHLORIDETrueWATSON LABORATORIES INC1988-06-01ANDA072164_001
10ANDA072285MAPROTILINE HYDROCHLORIDEMYLAN PHARMACEUTICALS INC1988-10-03ANDA072285_001, ANDA072285_002, ANDA072285_003
11NDA017543LUDIOMILTrueNOVARTIS PHARMACEUTICALS CORPNDA017543_001, NDA017543_002, NDA017543_003

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1ANDA071943_001discontinuedMAPROTILINE HYDROCHLORIDE (25MG)ORALTABLETFalse1987-12-30MAPROTILINE HYDROCHLORIDE
2ANDA071944_001discontinuedMAPROTILINE HYDROCHLORIDE (50MG)ORALTABLETFalse1987-12-30MAPROTILINE HYDROCHLORIDE
3ANDA071945_001discontinuedMAPROTILINE HYDROCHLORIDE (75MG)ORALTABLETFalse1987-12-30MAPROTILINE HYDROCHLORIDE
4ANDA072129_001discontinuedMAPROTILINE HYDROCHLORIDE (25MG)ORALTABLETFalse1988-01-14MAPROTILINE HYDROCHLORIDE
5ANDA072130_001discontinuedMAPROTILINE HYDROCHLORIDE (50MG)ORALTABLETFalse1988-01-14MAPROTILINE HYDROCHLORIDE
6ANDA072131_001discontinuedMAPROTILINE HYDROCHLORIDE (75MG)ORALTABLETFalse1988-01-14MAPROTILINE HYDROCHLORIDE
7ANDA072162_001discontinuedMAPROTILINE HYDROCHLORIDE (25MG)ORALTABLETFalse1988-06-01MAPROTILINE HYDROCHLORIDE
8ANDA072163_001discontinuedMAPROTILINE HYDROCHLORIDE (50MG)ORALTABLETFalse1988-06-01MAPROTILINE HYDROCHLORIDE
9ANDA072164_001discontinuedMAPROTILINE HYDROCHLORIDE (75MG)ORALTABLETFalse1988-06-01MAPROTILINE HYDROCHLORIDE
10ANDA072285_001RXMAPROTILINE HYDROCHLORIDE (50MG)ORALTABLETTrue1988-10-03MAPROTILINE HYDROCHLORIDE
11ANDA072285_002RXMAPROTILINE HYDROCHLORIDE (25MG)ORALTABLETFalse1988-10-03MAPROTILINE HYDROCHLORIDE
12ANDA072285_003RXMAPROTILINE HYDROCHLORIDE (75MG)ORALTABLETFalse1988-10-03MAPROTILINE HYDROCHLORIDE
13NDA017543_001discontinuedMAPROTILINE HYDROCHLORIDE (25MG)ORALTABLETFalseLUDIOMIL
14NDA017543_002discontinuedMAPROTILINE HYDROCHLORIDE (50MG)ORALTABLETFalseLUDIOMIL
15NDA017543_003discontinuedMAPROTILINE HYDROCHLORIDE (75MG)ORALTABLETFalse1982-09-30LUDIOMIL

spl(s)

#idtitlecategorytypelabelerlast updateversionproduct(s)
1c3ca69e6-1ea0-4c2c-abcb-7264b2e79a87 (view SPL)prescriptionHuman PrescriptionMylan Pharmaceuticals Inc.2014-12-2510003780060, 003780087, 003780092

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