Molindone Oral Tablet

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Corepharma, Llc (2014-11-21)
Oldest Current Product
2015-09-15
License(s)
ANDA
RxNORM
ORAL TABLET\MOLINDONE
FDAOB
ORAL\CAPSULE\MOLINDONE HYDROCHLORIDE
ORAL\TABLET\MOLINDONE HYDROCHLORIDE
SPL Active
ORAL\TABLET\MOLINDONE HYDROCHLORIDE
SPL Moiety
ORAL\TABLET\MOLINDONE

product(s) by strength(s)

molindone hydrochloride 10 mg oral tablet

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1647200229ANDACorepharma, Llc2015-09-15MOLINDONE HYDROCHLORIDEORALTABLETANDA090453138e8ca3-9a12-4c48-95c0-85bd01c79b13

molindone hydrochloride 25 mg oral tablet

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1647200230ANDACorepharma, Llc2015-09-15MOLINDONE HYDROCHLORIDEORALTABLETANDA090453138e8ca3-9a12-4c48-95c0-85bd01c79b13

molindone hydrochloride 5 mg oral tablet

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1647200228ANDACorepharma, Llc2015-09-15MOLINDONE HYDROCHLORIDEORALTABLETANDA090453138e8ca3-9a12-4c48-95c0-85bd01c79b13

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA090453MOLINDONE HYDROCHLORIDECOREPHARMA LLC2015-03-20ANDA090453_001, ANDA090453_002, ANDA090453_003
2NDA017111MOBANTrueENDO PHARMACEUTICALS INCNDA017111_001, NDA017111_002, NDA017111_003, NDA017111_004, NDA017111_005, NDA017111_006, NDA017111_007, NDA017111_008

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1ANDA090453_001RXMOLINDONE HYDROCHLORIDE (5MG)ORALTABLETFalse2015-03-20MOLINDONE HYDROCHLORIDE
2ANDA090453_002RXMOLINDONE HYDROCHLORIDE (10MG)ORALTABLETFalse2015-03-20MOLINDONE HYDROCHLORIDE
3ANDA090453_003RXMOLINDONE HYDROCHLORIDE (25MG)ORALTABLETTrue2015-03-20MOLINDONE HYDROCHLORIDE
4NDA017111_001discontinuedMOLINDONE HYDROCHLORIDE (5MG)ORALCAPSULEFalseMOBAN
5NDA017111_002discontinuedMOLINDONE HYDROCHLORIDE (10MG)ORALCAPSULEFalseMOBAN
6NDA017111_003discontinuedMOLINDONE HYDROCHLORIDE (25MG)ORALCAPSULEFalseMOBAN
7NDA017111_004discontinuedMOLINDONE HYDROCHLORIDE (5MG)ORALTABLETFalseMOBAN
8NDA017111_005discontinuedMOLINDONE HYDROCHLORIDE (10MG)ORALTABLETFalseMOBAN
9NDA017111_006discontinuedMOLINDONE HYDROCHLORIDE (25MG)ORALTABLETFalseMOBAN
10NDA017111_007discontinuedMOLINDONE HYDROCHLORIDE (50MG)ORALTABLETFalseMOBAN
11NDA017111_008discontinuedMOLINDONE HYDROCHLORIDE (100MG)ORALTABLETFalseMOBAN

spl(s)

#idtitlecategorytypelabelerlast updateversionproduct(s)
1138e8ca3-9a12-4c48-95c0-85bd01c79b13 (view SPL)Molindone Hydrochloride Tablets, USP5 mg, 10 mg and 25 mgRx onlyprescriptionHuman PrescriptionCorepharma, Llc2014-11-214647200228, 647200229, 647200230

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