Acitretin Oral Capsule

Brand(s)
Soriatane
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Stiefel Laboratories Inc (2015-05-19)
Oldest Current Product
1996-11-01
License(s)
NDA, NDA AUTHORIZED GENERIC, ANDA
RxNORM
ORAL CAPSULE\ACITRETIN
FDAOB
ORAL\CAPSULE\ACITRETIN
SPL Active
ORAL\CAPSULE\ACITRETIN
SPL Moiety
ORAL\CAPSULE\ACITRETIN

product(s) by strength(s)

acitretin 10 mg oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001450090SoriataneNDAStiefel Laboratories Inc1996-11-01ACITRETINORALCAPSULENDA019821cec7851f-c7af-4e9e-a5e4-a585c70510d2

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000931135ANDATeva Pharmaceuticals Usa Inc2013-07-19ACITRETINORALCAPSULEANDA091455993a5325-cd10-4450-b5ea-1c0a90510df6
2427940080ANDASigmapharm Laboratories, Llc2015-09-16ACITRETINORALCAPSULEANDA204633a6546625-acb8-460e-b34e-f795bfb3680a
3669930894NDA AUTHORIZED GENERICPrasco Laboratories2013-07-19ACITRETINORALCAPSULENDA019821fb979cda-6a34-496e-b4bc-b17782b67821

acitretin 17.5 mg oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001453817SoriataneNDAStiefel Laboratories Inc2010-01-04ACITRETINORALCAPSULENDA019821cec7851f-c7af-4e9e-a5e4-a585c70510d2

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000931138ANDATeva Pharmaceuticals Usa Inc2013-07-19ACITRETINORALCAPSULEANDA202897993a5325-cd10-4450-b5ea-1c0a90510df6
2427940081ANDASigmapharm Laboratories, Llc2015-09-16ACITRETINORALCAPSULEANDA204633a6546625-acb8-460e-b34e-f795bfb3680a

acitretin 25 mg oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001450091SoriataneNDAStiefel Laboratories Inc1996-11-01ACITRETINORALCAPSULENDA019821cec7851f-c7af-4e9e-a5e4-a585c70510d2

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000931136ANDATeva Pharmaceuticals Usa Inc2013-07-19ACITRETINORALCAPSULEANDA091455993a5325-cd10-4450-b5ea-1c0a90510df6
2427940083ANDASigmapharm Laboratories, Llc2015-09-16ACITRETINORALCAPSULEANDA204633a6546625-acb8-460e-b34e-f795bfb3680a
3669930896NDA AUTHORIZED GENERICPrasco Laboratories2013-07-19ACITRETINORALCAPSULENDA019821fb979cda-6a34-496e-b4bc-b17782b67821

application(s)

#idtitleapplicantapprovedapproved drug
1ANDA091455ACITRETINBARR LABORATORIES INC2013-04-04ANDA091455_001, ANDA091455_002
2ANDA202148ACITRETINMYLAN PHARMACEUTICALS INC2015-09-10ANDA202148_001, ANDA202148_002
3ANDA202897ACITRETINTEVA PHARMACEUTICALS USA2013-04-04ANDA202897_001, ANDA202897_002
4ANDA203707ACITRETINMYLAN PHARMACEUTICALS INC2015-09-10ANDA203707_001, ANDA203707_002
5ANDA204633ACITRETINSIGMAPHARM LABORATORIES LLC2015-05-22ANDA204633_001, ANDA204633_002, ANDA204633_003, ANDA204633_004
6NDA019821SORIATANESTIEFEL LABORATORIES INC1996-10-28NDA019821_001, NDA019821_002, NDA019821_003, NDA019821_004

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA091455_001RXACITRETIN (10MG)ORALCAPSULEFalseAB2013-04-04ACITRETIN
2ANDA091455_002RXACITRETIN (25MG)ORALCAPSULEFalseAB2013-04-04ACITRETIN
3ANDA202148_001RXACITRETIN (10MG)ORALCAPSULEFalseAB2015-09-10ACITRETIN
4ANDA202148_002RXACITRETIN (25MG)ORALCAPSULEFalseAB2015-09-10ACITRETIN
5ANDA202897_001RXACITRETIN (17.5MG)ORALCAPSULEFalseAB2013-04-04ACITRETIN
6ANDA202897_002RXACITRETIN (22.5MG)ORALCAPSULEFalseAB2013-04-04ACITRETIN
7ANDA203707_001RXACITRETIN (17.5MG)ORALCAPSULEFalseAB2015-09-10ACITRETIN
8ANDA203707_002RXACITRETIN (22.5MG)ORALCAPSULEFalseAB2015-09-10ACITRETIN
9ANDA204633_001RXACITRETIN (10MG)ORALCAPSULEFalseAB2015-05-22ACITRETIN
10ANDA204633_002RXACITRETIN (17.5MG)ORALCAPSULEFalseAB2015-05-22ACITRETIN
11ANDA204633_003RXACITRETIN (22.5MG)ORALCAPSULEFalseAB2015-05-22ACITRETIN
12ANDA204633_004RXACITRETIN (25MG)ORALCAPSULEFalseAB2015-05-22ACITRETIN
13NDA019821_001RXACITRETIN (10MG)ORALCAPSULEFalseAB1996-10-28SORIATANE
14NDA019821_002RXACITRETIN (25MG)ORALCAPSULETrueAB1996-10-28SORIATANE
15NDA019821_003RXACITRETIN (17.5MG)ORALCAPSULEFalseAB2009-08-06SORIATANE
16NDA019821_004RXACITRETIN (22.5MG)ORALCAPSULEFalseAB2009-08-06SORIATANE

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1993a5325-cd10-4450-b5ea-1c0a90510df6 (view SPL)Acitretin Capsules USPprescriptionHuman PrescriptionTeva Pharmaceuticals Usa Inc2015-08-265000931135, 000931136, 000931138
2a6546625-acb8-460e-b34e-f795bfb3680a (view SPL)prescriptionHuman PrescriptionSigmapharm Laboratories, Llcanalysis, manufacture2015-09-143427940080, 427940081, 427940083
3cec7851f-c7af-4e9e-a5e4-a585c70510d2 (view SPL)SORIATANE (acitretin) CapsulesprescriptionHuman PrescriptionStiefel Laboratories Inc2015-05-1918001450090, 001450091, 001453817
4fb979cda-6a34-496e-b4bc-b17782b67821 (view SPL)Acitretin CapsulesprescriptionHuman PrescriptionPrasco Laboratories2015-05-296669930894, 669930896

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