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 1 of 4 · 72 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ENDOMETRINPROGESTERONEFerring Pharmaceuticals Inc.2ba50fa9-b349-40cb-9a4b-1af8faa4ec092026-07-29Warnings, Adverse reactionsName fallback
generic name: PROGESTERONE
ProgesteronePROGESTERONEREMEDYREPACK INC.f7615864-be6e-47b4-bf35-145a361d7cc62026-07-27Boxed warning, Warnings, Adverse reactionsName fallback
generic name: PROGESTERONE
PrometriumPROGESTERONEAcertis Pharmaceuticals, LLC1cf237ff-c4f8-4faa-a7aa-77599c8568892026-07-23Warnings, Adverse reactionsName fallback
brand name: Prometrium
generic name: PROGESTERONE
ProgesteronePROGESTERONERedpharm Drug5743b2e4-093f-c59a-e063-6394a90aae2b2026-07-23Warnings, Adverse reactionsName fallback
generic name: PROGESTERONE
ProgesteronePROGESTERONENorthStar Rx LLCf392c6d9-1420-4735-aa01-f434da9b31b32026-06-30Boxed warning, Warnings, Adverse reactionsName fallback
generic name: PROGESTERONE
ProgesteronePROGESTERONEA-S Medication Solutionsbc62ae6d-b609-432d-863f-a8ecd223d69a2026-06-23Boxed warning, Warnings, Adverse reactionsName fallback
generic name: PROGESTERONE
PROGESTERONEPROGESTERONEGolden State Medical Supply, Inc.312db3af-9dd2-d5e4-e063-6394a90af9992026-06-18Warnings, Adverse reactionsName fallback
generic name: PROGESTERONE
ProgesteronePROGESTERONEAvKARE42c84fec-e5eb-78f7-e063-6294a90a4c0e2026-06-16Warnings, Adverse reactionsName fallback
generic name: PROGESTERONE
ProgesteronePROGESTERONEBryant Ranch Prepack1ba10f9d-6e91-4954-ac91-23adcf8805b02026-06-09Boxed warning, Warnings, Adverse reactionsName fallback
generic name: PROGESTERONE
ProgesteronePROGESTERONEBryant Ranch Prepack74a7619a-8f74-4889-96f6-5bae478543e82026-06-09Boxed warning, Warnings, Adverse reactionsName fallback
generic name: PROGESTERONE
PROGESTERONEPROGESTERONEBionpharma Inc.41b3c3a7-5fb8-4451-a96c-2bd02613c0212026-05-29Warnings, Adverse reactionsName fallback
generic name: PROGESTERONE
PROGESTERONEPROGESTERONESun Pharmaceutical Industries, Inc.fcdde0d0-4329-4725-a76b-684f9d97fe952026-05-19Warnings, Adverse reactionsName fallback
generic name: PROGESTERONE
ProgesteronePROGESTERONEAvKARE1637ac18-3a37-f3d5-e063-6394a90af1572026-05-13Boxed warning, Warnings, Adverse reactionsName fallback
generic name: PROGESTERONE
PROGESTERONEPROGESTERONEA-S Medication Solutions566584fc-c76a-4e42-a62e-109a2903b9392026-05-11Boxed warning, Warnings, Adverse reactionsName fallback
generic name: PROGESTERONE
Natural ProgesteronePROGESTERONEBioActive Nutritional, Inc.772629aa-af5e-4493-aaf2-3c75bfd7d8c22026-05-05WarningsName fallback
generic name: PROGESTERONE
ProgesteronePROGESTERONEHikma Pharmaceuticals USA Incd8bcc439-c21d-4eeb-9159-f51e0c60bd702026-04-28Warnings, Adverse reactionsName fallback
generic name: PROGESTERONE
PROGESTERONE VAGINAL INSERTSPROGESTERONEGlenmark Pharmaceuticals Inc., USA41682665-e889-4e2a-9382-88f6bcc302372026-04-17Warnings, Adverse reactionsName fallback
generic name: PROGESTERONE
ProgesteronePROGESTERONEBioActive Nutritional, Inc.cddb5afa-9825-418d-acf6-cffbb0fc39c32026-03-10WarningsName fallback
generic name: PROGESTERONE
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

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