Progesterone Oral Capsule

Brand(s)
Prometrium
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Watson Laboratories, Inc. (2014-01-16)
Oldest Current Product
2003-03-14
License(s)
NDA, ANDA
RxNORM
ORAL CAPSULE\PROGESTERONE
FDAOB
ORAL\CAPSULE\PROGESTERONE
SPL Active
ORAL\CAPSULE\PROGESTERONE
SPL Moiety
ORAL\CAPSULE\PROGESTERONE

product(s) by strength(s)

progesterone 100 mg oral capsule

original product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1005913964NDAWatson Laboratories, Inc.2010-07-30PROGESTERONEORALCAPSULENDA019781849e9f62-7414-3c22-9cb1-934f953400fc

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000935353ANDATeva Pharmaceuticals Usa Inc2012-03-01PROGESTERONEORALCAPSULEANDA202121dc64d6d6-b773-4f6b-b563-d389bf89bbc5
2108887135ANDABanner Pharmacaps2014-01-01PROGESTERONEORALCAPSULEANDA200900f7cc2093-86ad-4959-a4ed-7a72148f3d74
3174780766ANDAAkorn2012-10-04PROGESTERONEORALCAPSULEANDA200456d9e6ec7d-85ea-41a7-88ec-88cac22d5b7d
4422910690ANDAAvkare, Inc.2014-09-29PROGESTERONEORALCAPSULEANDA200900eea570eb-446d-4a5f-626b-7557017f6a55
5693870101ANDABanner Life Sciences Llc.2015-10-01PROGESTERONEORALCAPSULEANDA200900d8925bba-f002-4455-a28f-eb6a888b4fe6

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1548684250PrometriumNDAPhysicians Total Care, Inc.2003-03-14PROGESTERONEORALCAPSULE000321708NDA019781cf73c385-5173-4b54-af23-069581c5d560
2604290281ANDAGolden State Medical Supply, Inc.2014-04-23PROGESTERONEORALCAPSULE108887135ANDA200900bfdf0e74-5f8e-4ae8-b766-5037b04370bd
3636292770PrometriumNDABryant Ranch Prepack2010-07-30PROGESTERONEORALCAPSULE000321708NDA0197815571d5dd-b221-43b5-aec5-c6551ac67352

progesterone 200 mg oral capsule

original product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1005913965NDAWatson Laboratories, Inc.2010-07-30PROGESTERONEORALCAPSULENDA019781849e9f62-7414-3c22-9cb1-934f953400fc

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000935354ANDATeva Pharmaceuticals Usa Inc2012-03-01PROGESTERONEORALCAPSULEANDA202121dc64d6d6-b773-4f6b-b563-d389bf89bbc5
2108887136ANDABanner Pharmacaps2014-01-01PROGESTERONEORALCAPSULEANDA200900f7cc2093-86ad-4959-a4ed-7a72148f3d74
3174780767ANDAAkorn2012-10-04PROGESTERONEORALCAPSULEANDA200456d9e6ec7d-85ea-41a7-88ec-88cac22d5b7d
4422910691ANDAAvkare, Inc.2014-09-29PROGESTERONEORALCAPSULEANDA200900eea570eb-446d-4a5f-626b-7557017f6a55
5693870102ANDABanner Life Sciences Llc.2015-10-01PROGESTERONEORALCAPSULEANDA200900d8925bba-f002-4455-a28f-eb6a888b4fe6

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1548684230PrometriumNDAPhysicians Total Care, Inc.2004-11-03PROGESTERONEORALCAPSULE00032171101NDA019781cf73c385-5173-4b54-af23-069581c5d560
2604290282ANDAGolden State Medical Supply, Inc.2014-04-23PROGESTERONEORALCAPSULE108887136ANDA200900bfdf0e74-5f8e-4ae8-b766-5037b04370bd
3636292767PrometriumNDABryant Ranch Prepack2010-07-30PROGESTERONEORALCAPSULE000321711NDA01978167d5fef2-19b5-4bde-acb6-93a4da8d3a09

application(s)

#idtitleapplicantapprovedapproved drug
1ANDA200456PROGESTERONESOFGEN PHARMACEUTICALS LLC2012-09-28ANDA200456_001, ANDA200456_002
2ANDA200900PROGESTERONEBANNER LIFE SCIENCES LLC2013-08-16ANDA200900_001, ANDA200900_002
3ANDA202121PROGESTERONETEVA PHARMACEUTICALS USA2012-02-29ANDA202121_001, ANDA202121_002
4NDA019781PROMETRIUMABBVIE INC1998-05-14NDA019781_001, NDA019781_002, NDA019781_003

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA200456_001RXPROGESTERONE (100MG)ORALCAPSULEFalseAB2012-09-28PROGESTERONE
2ANDA200456_002RXPROGESTERONE (200MG)ORALCAPSULEFalseAB2012-09-28PROGESTERONE
3ANDA200900_001RXPROGESTERONE (100MG)ORALCAPSULEFalseAB2013-08-16PROGESTERONE
4ANDA200900_002RXPROGESTERONE (200MG)ORALCAPSULEFalseAB2013-08-16PROGESTERONE
5ANDA202121_001RXPROGESTERONE (100MG)ORALCAPSULEFalseAB2012-02-29PROGESTERONE
6ANDA202121_002RXPROGESTERONE (200MG)ORALCAPSULEFalseAB2012-02-29PROGESTERONE
7NDA019781_001RXPROGESTERONE (100MG)ORALCAPSULEFalseAB1998-05-14PROMETRIUM
8NDA019781_002RXPROGESTERONE (200MG)ORALCAPSULETrueAB1999-10-15PROMETRIUM
9NDA019781_003discontinuedPROGESTERONE (300MG)ORALCAPSULEFalse1999-10-15PROMETRIUM

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
10224b5a6-25a3-44c9-b94f-90e2e064c164 (view SPL)PROMETRIUM(progesterone, USP)Capsules 100 mgCapsules 200 mgprescriptionHuman PrescriptionAbbvie Inc.2013-09-3019000321708, 000321711
25571d5dd-b221-43b5-aec5-c6551ac67352 (view SPL)PROMETRIUM(progesterone, USP)Capsules 100 mgCapsules 200 mgprescriptionHuman PrescriptionBryant Ranch PrepackRELABEL, REPACK2013-01-181000636292770
367d5fef2-19b5-4bde-acb6-93a4da8d3a09 (view SPL)PROMETRIUM(progesterone, USP)Capsules 100 mgCapsules 200 mgprescriptionHuman PrescriptionBryant Ranch PrepackRELABEL, REPACK2013-01-161000636292767
4849e9f62-7414-3c22-9cb1-934f953400fc (view SPL)Progesterone, USPCapsules 100 mgCapsules 200 mgprescriptionHuman PrescriptionWatson Laboratories, Inc.2014-01-1618005913964, 005913965
5bfdf0e74-5f8e-4ae8-b766-5037b04370bd (view SPL)ProgesteroneCapsules 100mg and 200mgprescriptionHuman PrescriptionGolden State Medical Supply, Inc.RELABEL, REPACK2013-12-311604290281, 604290282
6cf73c385-5173-4b54-af23-069581c5d560 (view SPL)prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel, repack2010-08-241548684230, 548684250
7d8925bba-f002-4455-a28f-eb6a888b4fe6 (view SPL)prescriptionHuman PrescriptionBanner Life Sciences Llc.ANALYSIS, MANUFACTURE2015-09-301693870101, 693870102
8d9e6ec7d-85ea-41a7-88ec-88cac22d5b7d (view SPL)ProgesteroneCapsules 100 mgCapsules 200 mgprescriptionHuman PrescriptionAkorn2013-01-314174780766, 174780767
9dc64d6d6-b773-4f6b-b563-d389bf89bbc5 (view SPL)Progesterone CapsulesprescriptionHuman PrescriptionTeva Pharmaceuticals Usa Inc2012-03-011000935353, 000935354
10eea570eb-446d-4a5f-626b-7557017f6a55 (view SPL)prescriptionHuman PrescriptionAvkare, Inc.2014-09-291422910690, 422910691
11f7cc2093-86ad-4959-a4ed-7a72148f3d74 (view SPL)prescriptionHuman PrescriptionBanner PharmacapsANALYSIS, API MANUFACTURE, MANUFACTURE2013-11-2211108887135, 108887136

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