Tretinoin Oral Capsule

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Barr Laboratories Inc. (2012-05-11)
Oldest Current Product
2007-06-26
License(s)
ANDA
RxNORM
ORAL CAPSULE\TRETINOIN
FDAOB
ORAL\CAPSULE\TRETINOIN
SPL Active
ORAL\CAPSULE\TRETINOIN
SPL Moiety
ORAL\CAPSULE\TRETINOIN

product(s) by strength(s)

tretinoin 10 mg oral capsule

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1005550808ANDABarr Laboratories Inc.2007-06-26TRETINOINORALCAPSULEANDA0776840f81f505-a962-414e-8612-c3ef3b159e9a
2103700268ANDAPar Pharmaceutical, Inc.2012-10-24TRETINOINORALCAPSULEANDA2016879c4ae9d9-c2a0-4995-a27a-e3f0f0284db9

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1680840075ANDAAmerican Health Packaging2013-07-18TRETINOINORALCAPSULE103700268ANDA201687b22d5a07-623a-4645-b87d-a151b86da8d5

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA077684TRETINOINBARR LABORATORIES INC2007-06-22ANDA077684_001
2ANDA201687TRETINOINANCHEN PHARMACEUTICALS INC2012-10-24ANDA201687_001
3NDA020438VESANOIDTrueHOFFMANN LA ROCHE INC1995-11-22NDA020438_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA077684_001RXTRETINOIN (10MG)ORALCAPSULETrueAB2007-06-22TRETINOIN
2ANDA201687_001RXTRETINOIN (10MG)ORALCAPSULEFalseAB2012-10-24TRETINOIN
3NDA020438_001discontinuedTRETINOIN (10MG)ORALCAPSULEFalse1995-11-22VESANOID

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
10f81f505-a962-414e-8612-c3ef3b159e9a (view SPL)TRETINOIN CapsulesprescriptionHuman PrescriptionBarr Laboratories Inc.2012-05-112005550808
29c4ae9d9-c2a0-4995-a27a-e3f0f0284db9 (view SPL)Tretinoin CapsulesprescriptionHuman PrescriptionPar Pharmaceutical, Inc.ANALYSIS, MANUFACTURE2011-12-011103700268
3b22d5a07-623a-4645-b87d-a151b86da8d5 (view SPL)Tretinoin CapsulesprescriptionHuman PrescriptionAmerican Health PackagingREPACK2013-07-181680840075

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