Pimozide Oral Tablet

Brand(s)
Orap
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Teva Select Brands (2014-10-31)
Oldest Current Product
1990-09-30
License(s)
NDA, ANDA
RxNORM
ORAL TABLET\PIMOZIDE
FDAOB
ORAL\TABLET\PIMOZIDE
SPL Active
ORAL\TABLET\PIMOZIDE
SPL Moiety
ORAL\TABLET\PIMOZIDE

product(s) by strength(s)

pimozide 1 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1578440151OrapNDATeva Select Brands2000-06-07PIMOZIDEORALTABLETNDA01747390c0086a-b62c-4cdd-a6af-2efed69cfd4d

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1498840347ANDAPar Pharmaceutical Companies, Inc.2014-12-01PIMOZIDEORALTABLETANDA20452170b079e2-a1f7-4a93-8685-d60a4d7c1280

pimozide 2 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedlast marketedactive ingredient(s)routedose formapplicationspl
1578440187OrapNDATeva Select Brands1990-09-302017-10-31PIMOZIDEORALTABLETNDA017473fd9729c3-545f-4d34-9bc7-72b61e028fc4

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1498840348ANDAPar Pharmaceutical Companies, Inc.2014-12-01PIMOZIDEORALTABLETANDA20452170b079e2-a1f7-4a93-8685-d60a4d7c1280

application(s)

#idtitleapplicantapprovedapproved drug
1ANDA204521PIMOZIDEPAR PHARMACEUTICAL INC2015-09-28ANDA204521_001, ANDA204521_002
2NDA017473ORAPTEVA PHARMACEUTICALS USA INC1984-07-31NDA017473_001, NDA017473_003

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA204521_001RXPIMOZIDE (1MG)ORALTABLETFalseAB2015-09-28PIMOZIDE
2ANDA204521_002RXPIMOZIDE (2MG)ORALTABLETFalseAB2015-09-28PIMOZIDE
3NDA017473_001RXPIMOZIDE (2MG)ORALTABLETTrueAB1984-07-31ORAP
4NDA017473_003RXPIMOZIDE (1MG)ORALTABLETFalseAB1997-08-27ORAP

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
170b079e2-a1f7-4a93-8685-d60a4d7c1280 (view SPL)Pimozide Tablets, USPprescriptionHuman PrescriptionPar Pharmaceutical Companies, Inc.MANUFACTURE2014-12-051498840347, 498840348
290c0086a-b62c-4cdd-a6af-2efed69cfd4d (view SPL)ORAP (Pimozide)TabletsprescriptionHuman PrescriptionTeva Select Brands2014-10-311578440151, 578440198
3fd9729c3-545f-4d34-9bc7-72b61e028fc4 (view SPL)ORAP (Pimozide) TabletsprescriptionHuman PrescriptionTeva Select Brands2014-10-319578440187

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