FDA.reportPublic FDA data

Application 020843

Type
NDA
Sponsor
VIRTUS PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PROMETRIUMPROGESTERONECAPSULE; ORAL100MGNoNo
002PROMETRIUMPROGESTERONECAPSULE; ORAL200MGNoNo
003PROMETRIUMPROGESTERONECAPSULE; ORAL300MGNoNo

Source provenance: Browse the complete Orange Book source catalog.

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 2 of 4 · 69 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ProgesteronePROGESTERONEAmneal Pharmaceuticals LLC4de0715d-a3b9-42fa-b4e4-6371151fd75c2026-02-24Warnings, Adverse reactionsName fallback
generic name: PROGESTERONE
ProgesteronePROGESTERONENorthstar Rx LLC73229a76-8de3-4cea-886f-568f0b817fea2026-02-19Warnings, Adverse reactionsName fallback
generic name: PROGESTERONE
ProgesteronePROGESTERONEXiromed, LLC0bf317a8-96d6-849d-7850-9084205a53152026-02-17Warnings, Adverse reactionsName fallback
generic name: PROGESTERONE
PROGESTERONEPROGESTERONEProficient Rx LP199c8575-e113-468f-8eb7-c4930030649c2026-02-01Boxed warning, Warnings, Adverse reactionsName fallback
generic name: PROGESTERONE
PROGESTERONEPROGESTERONEBryant Ranch Prepack46d97ca6-970f-478f-81ff-1b9a9f6cb2f72026-01-29Boxed warning, Warnings, Adverse reactionsName fallback
generic name: PROGESTERONE
ProgesteronePROGESTERONEPreferred Pharmaceuticals Inc.eca6a7c0-7f58-4dcf-aec0-9d44fd594aa12026-01-28Boxed warning, Warnings, Adverse reactionsName fallback
generic name: PROGESTERONE
ProgesteronePROGESTERONENuCare Pharmaceuticals,Inc.4884017f-3314-cd26-e063-6294a90a4e7e2026-01-16Boxed warning, Warnings, Adverse reactionsName fallback
generic name: PROGESTERONE
ProgesteronePROGESTERONENuCare Pharmaceuticals, Inc.4874ee1b-f661-05f7-e063-6394a90a2b8b2026-01-16Boxed warning, Warnings, Adverse reactionsName fallback
generic name: PROGESTERONE
Progesterone 1538PROGESTERONEProfessional Complementary Health Formulasa5b8449e-ae6f-48c1-8b71-2dd3c5332cc12026-01-08WarningsName fallback
generic name: PROGESTERONE
Progesterone vaginal insertPROGESTERONEXIROMED, LLC473ab609-5b9e-3cb8-68d5-4a459a2ea6c12026-01-06Warnings, Adverse reactionsName fallback
generic name: PROGESTERONE
ProgesteronePROGESTERONENorthwind Health Company, LLCfcebe343-18ac-d4cd-e053-6294a90a72d52026-01-01Boxed warning, Warnings, Adverse reactionsName fallback
generic name: PROGESTERONE
ProgesteronePROGESTERONEDirect_Rx462ae686-7264-4852-e063-6294a90aae982025-12-17Boxed warning, Warnings, Adverse reactionsName fallback
generic name: PROGESTERONE
BUNUSS Phyto-Pro Skin CreamPROGESTERONEJiashen International Trade Limited44e1ec89-e2ea-d438-e063-6294a90a41f42025-12-01WarningsName fallback
generic name: PROGESTERONE
PROGESTERONEPROGESTERONENuCare Pharmaceuticals,Inc.0b3da881-4720-cdee-e063-6394a90aee992025-11-03Boxed warning, Warnings, Adverse reactionsName fallback
generic name: PROGESTERONE
PROGESTERONEPROGESTERONEPreferred Pharmaceuticals Inc.41c9546c-a854-4395-9506-d1be61f4e60f2025-09-16Boxed warning, Warnings, Adverse reactionsName fallback
generic name: PROGESTERONE
ProgesteronePROGESTERONEPreferred Pharmaceuticals Inc.c768aead-153b-42f3-bb4d-b06e30ebad802025-09-05Boxed warning, Warnings, Adverse reactionsName fallback
generic name: PROGESTERONE
P25 Progesterone CreamPROGESTERONESHYNE BRANDSc47169b7-1b6a-2ad0-e053-2995a90a0b192025-06-01WarningsName fallback
generic name: PROGESTERONE
P75 Lav Progesterone CreamPROGESTERONESHYNE BRANDSc4711337-7c1f-3556-e053-2a95a90a7b822025-06-01WarningsName fallback
generic name: PROGESTERONE
P50 Progesterone CreamPROGESTERONESHYNE BRANDSc47121df-6c04-b273-e053-2a95a90aa5492025-06-01WarningsName fallback
generic name: PROGESTERONE
ProgesteronePROGESTERONEBioActive Nutritional, Inc.0de91238-dacc-4a5c-86d8-ad94024b2c952025-05-20WarningsName fallback
generic name: PROGESTERONE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
35497SUPPL2011-11-04
26031SUPPL2011-11-03
3547SUPPL2009-07-07
35496SUPPL2009-07-06
41757ORIG2005-06-16
26029SUPPL2004-12-10
26028SUPPL2004-12-10
13589SUPPL2004-12-10
13588SUPPL2004-12-10
26030SUPPL2004-03-10
35495ORIG1998-12-16
26027ORIG1998-12-16