Propylthiouracil Oral Tablet

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Dava Pharmaceuticals, Inc. (2015-08-19)
Oldest Current Product
1947-07-28
License(s)
NDA, ANDA
RxNORM
ORAL TABLET\PROPYLTHIOURACIL
FDAOB
ORAL\TABLET\PROPYLTHIOURACIL
SPL Active
ORAL\TABLET\PROPYLTHIOURACIL
SPL Moiety
ORAL\TABLET\PROPYLTHIOURACIL

product(s) by strength(s)

propylthiouracil 50 mg oral tablet

original product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1672530651NDADava Pharmaceuticals, Inc.1947-07-28PROPYLTHIOURACILORALTABLETNDA006188b0c23a2c-b250-4c0d-9b2a-c1483faa2ca0

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1002282348ANDAActavis Elizabeth Llc2006-01-15PROPYLTHIOURACILORALTABLETANDA080172a57c49ae-d659-49fa-84e3-cf6d1f9e6f97

invalid application product(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1001431480ANDAWest-Ward Pharmaceutical Corp1971-07-23PROPYLTHIOURACILORALTABLETANDA080154d270ea0a-bbcf-4a87-8299-8cbe03c13958
2242360204ANDARemedyrepack Inc.2013-03-20PROPYLTHIOURACILORALTABLET001431480ANDA080154b7015fe1-5a77-49d8-9c17-bc6f90e4dcae
3422540010ANDARebel Distributors Corp1971-07-23PROPYLTHIOURACILORALTABLET001431480ANDA080154ff603c99-6620-4945-acdc-c9150b6f77d4
4422910550ANDAAvkare, Inc.1997-01-01PROPYLTHIOURACILORALTABLET001431480ANDA08015488765882-d76e-2464-8a8f-e51afb2b4633
5551547453ANDACardinal Health1982-01-01PROPYLTHIOURACILORALTABLET001431480ANDA080154103c6393-d5c9-4efd-817c-2d6e5fec1704

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1006157583ANDANcs Healthcare Of Ky, Inc Dba Vangard Labs1973-01-09PROPYLTHIOURACILORALTABLET002282348ANDA080172c46c4f31-121c-43a8-9538-53ae1288812e
2493490929ANDARemedyrepack Inc.2012-03-23PROPYLTHIOURACILORALTABLET002282348ANDA08017221ddca95-6dc0-416e-a868-891a7f94c1d8
3551545996ANDACardinal Health2006-01-15PROPYLTHIOURACILORALTABLET002282348ANDA080172120de758-f102-470a-892d-a61b18ff8f71
4581180651NDAClinical Solutions Wholesale2010-01-29PROPYLTHIOURACILORALTABLET672530651NDA0061885072d6d2-2fc1-4d53-92e7-23f588ef5b33
5680840964NDAAmerican Health Packaging2015-09-15PROPYLTHIOURACILORALTABLET672530651NDA006188d819e532-09ac-434a-84a6-636c4204c7aa

application(s)

#idtitledeprecatedapplicantapproved drug
1ANDA080015PROPYLTHIOURACILTrueHALSEY DRUG CO INCANDA080015_001
2ANDA080016PROPYLTHIOURACILTrueLANNETT CO INCANDA080016_001
3ANDA080154PROPYLTHIOURACILTrueHIKMA PHARMACEUTICALS LLCANDA080154_001
4ANDA080159PROPYLTHIOURACILTrueIMPAX LABORATORIES INCANDA080159_001
5ANDA080172PROPYLTHIOURACILACTAVIS ELIZABETH LLCANDA080172_001
6ANDA080215PROPYLTHIOURACILTrueANI PHARMACEUTICALS INCANDA080215_001
7ANDA080285PROPYLTHIOURACILTrueANABOLIC INCANDA080285_001
8ANDA080840PROPYLTHIOURACILTrueTABLICAPS INCANDA080840_001
9ANDA080932PROPYLTHIOURACILTrueWATSON LABORATORIES INCANDA080932_001
10ANDA083982PROPYLTHIOURACILTrueMUTUAL PHARMACEUTICAL CO INCANDA083982_001
11ANDA084075PROPYLTHIOURACILTrueABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIVANDA084075_001
12ANDA084543PROPYLTHIOURACILTrueL PERRIGO COANDA084543_001
13ANDA085201PROPYLTHIOURACILTrueWATSON LABORATORIES INCANDA085201_001
14NDA006188PROPYLTHIOURACILDAVA PHARMACEUTICALS INCNDA006188_001
15NDA006213PROPYLTHIOURACILTrueELI LILLY AND CONDA006213_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapplication
1ANDA080015_001discontinuedPROPYLTHIOURACIL (50MG)ORALTABLETFalsePROPYLTHIOURACIL
2ANDA080016_001discontinuedPROPYLTHIOURACIL (50MG)ORALTABLETFalsePROPYLTHIOURACIL
3ANDA080154_001discontinuedPROPYLTHIOURACIL (50MG)ORALTABLETFalsePROPYLTHIOURACIL
4ANDA080159_001discontinuedPROPYLTHIOURACIL (50MG)ORALTABLETFalsePROPYLTHIOURACIL
5ANDA080172_001RXPROPYLTHIOURACIL (50MG)ORALTABLETFalseBDPROPYLTHIOURACIL
6ANDA080215_001discontinuedPROPYLTHIOURACIL (50MG)ORALTABLETFalsePROPYLTHIOURACIL
7ANDA080285_001discontinuedPROPYLTHIOURACIL (50MG)ORALTABLETFalsePROPYLTHIOURACIL
8ANDA080840_001discontinuedPROPYLTHIOURACIL (50MG)ORALTABLETFalsePROPYLTHIOURACIL
9ANDA080932_001discontinuedPROPYLTHIOURACIL (50MG)ORALTABLETFalsePROPYLTHIOURACIL
10ANDA083982_001discontinuedPROPYLTHIOURACIL (50MG)ORALTABLETFalsePROPYLTHIOURACIL
11ANDA084075_001discontinuedPROPYLTHIOURACIL (50MG)ORALTABLETFalsePROPYLTHIOURACIL
12ANDA084543_001discontinuedPROPYLTHIOURACIL (50MG)ORALTABLETFalsePROPYLTHIOURACIL
13ANDA085201_001discontinuedPROPYLTHIOURACIL (50MG)ORALTABLETFalsePROPYLTHIOURACIL
14NDA006188_001RXPROPYLTHIOURACIL (50MG)ORALTABLETTrueBDPROPYLTHIOURACIL
15NDA006213_001discontinuedPROPYLTHIOURACIL (50MG)ORALTABLETFalsePROPYLTHIOURACIL

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1103c6393-d5c9-4efd-817c-2d6e5fec1704 (view SPL)PROPYLTHIOURACIL TABLETS, USPprescriptionHuman PrescriptionCardinal HealthREPACK2012-06-264551547453
2120de758-f102-470a-892d-a61b18ff8f71 (view SPL)PROPYLTHIOURACIL TABLETS, USP 40-9158prescriptionHuman PrescriptionCardinal HealthREPACK2012-07-031551545996
321ddca95-6dc0-416e-a868-891a7f94c1d8 (view SPL)prescriptionHuman PrescriptionRemedyrepack Inc.2012-03-231493490929
45072d6d2-2fc1-4d53-92e7-23f588ef5b33 (view SPL)PROPYLTHIOURACIL TABLETS, USPprescriptionHuman PrescriptionClinical Solutions WholesaleRELABEL, REPACK2014-07-011581180651
588765882-d76e-2464-8a8f-e51afb2b4633 (view SPL)PROPYLTHIOURACILTABLETS, USPprescriptionHuman PrescriptionAvkare, Inc.2010-06-144422910550
6a57c49ae-d659-49fa-84e3-cf6d1f9e6f97 (view SPL)PROPYLTHIOURACIL TABLETS, USPprescriptionHuman PrescriptionActavis Elizabeth LlcMANUFACTURE2011-09-296002282348
7b0c23a2c-b250-4c0d-9b2a-c1483faa2ca0 (view SPL)PROPYLTHIOURACIL TABLETS, USPprescriptionHuman PrescriptionDava Pharmaceuticals, Inc.2015-08-197672530651
8b7015fe1-5a77-49d8-9c17-bc6f90e4dcae (view SPL)PROPYLTHIOURACIL TABLETS, USPprescriptionHuman PrescriptionRemedyrepack Inc.2013-03-201242360204
9c46c4f31-121c-43a8-9538-53ae1288812e (view SPL)PROPYLTHIOURACIL TABLETS, USP 40-8756 Revised January 2008 Rx onlyprescriptionHuman PrescriptionNcs Healthcare Of Ky, Inc Dba Vangard LabsRELABEL, REPACK2010-05-271006157583
10d270ea0a-bbcf-4a87-8299-8cbe03c13958 (view SPL)PROPYLTHIOURACIL TABLETS, USPprescriptionHuman PrescriptionWest-Ward Pharmaceutical CorpMANUFACTURE2014-08-087001431480
11d819e532-09ac-434a-84a6-636c4204c7aa (view SPL)Propylthiouracil Tablets, USP 8296421/0915OS Rx onlyprescriptionHuman PrescriptionAmerican Health PackagingREPACK2015-09-041680840964
12ff603c99-6620-4945-acdc-c9150b6f77d4 (view SPL)PROPYLTHIOURACIL TABLETS, USPprescriptionHuman PrescriptionRebel Distributors CorpRELABEL, REPACK2011-10-181422540010

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