Progesterone Prefilled Applicator

Brand(s)
Crinone
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Actavis Pharma, Inc. (2014-08-06)
Oldest Current Product
1997-05-13
License(s)
NDA
RxNORM
PREFILLED APPLICATOR\PROGESTERONE
FDAOB
VAGINAL\GEL\PROGESTERONE
SPL Active
VAGINAL\GEL\PROGESTERONE
SPL Moiety
VAGINAL\GEL\PROGESTERONE

product(s) by strength(s)

1125 mg progesterone 0.04 mg/mg prefilled applicator

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1525440255CrinoneNDAActavis Pharma, Inc.1997-05-13PROGESTERONEVAGINALGELNDA0207017def92fe-d521-41c0-b419-48e028f59f15
2525440283CrinoneNDAActavis Pharma, Inc.1997-05-13PROGESTERONEVAGINALGELNDA0207017def92fe-d521-41c0-b419-48e028f59f15

1125 mg progesterone 0.08 mg/mg prefilled applicator

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1525440284CrinoneNDAActavis Pharma, Inc.1997-05-13PROGESTERONEVAGINALGELNDA0207017def92fe-d521-41c0-b419-48e028f59f15
2550560806CrinoneNDAColumbia Laboratories1997-05-13PROGESTERONEVAGINALGELNDA0207012c8ffbd2-6b7a-42c7-b29e-e4de69dad9e6

application(s)

#idtitleapplicantapprovedapproved drugin other drug docs
1NDA020701CRINONEACTAVIS LABORATORIES UT INC1997-07-31NDA020701_001, NDA020701_002Progesterone Vaginal Gel

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA020701_001RXPROGESTERONE (4%)VAGINALGELFalse1997-07-31CRINONE
2NDA020701_002RXPROGESTERONE (8%)VAGINALGELTrue1997-07-31CRINONE

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
12c8ffbd2-6b7a-42c7-b29e-e4de69dad9e6 (view SPL)Crinone 4% Crinone 8% (progesterone gel)prescriptionHuman PrescriptionColumbia LaboratoriesREPACK2009-11-192550560806, 550560808, 550560818
27def92fe-d521-41c0-b419-48e028f59f15 (view SPL)Crinone 4% and Crinone 8%(progesterone gel)PHYSICIAN INFORMATIONFor Vaginal Use OnlyRx onlyContent Updated: August 2014prescriptionHuman PrescriptionActavis Pharma, Inc.2014-08-0613525440255, 525440283, 525440284, 525440256

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