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 3 of 4 · 69 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PROGESTERONEPROGESTERONEBryant Ranch Prepack0aeb0f0f-2749-416b-942f-83950200fd752025-05-16Boxed warning, Warnings, Adverse reactionsName fallback
generic name: PROGESTERONE
PROGESTERONEPROGESTERONEAsclemed USA, Inc.342a096d-df6f-47de-bdd1-ec259638e4762025-05-07Boxed warning, Warnings, Adverse reactionsName fallback
generic name: PROGESTERONE
PROGESTERONEPROGESTERONEXIROMED, LLCdcfa4050-d142-b774-369f-8a421eb23c622025-03-06Warnings, Adverse reactionsName fallback
generic name: PROGESTERONE
ProgesteronePROGESTERONENewton Laboratories, Inc.9e038e0b-a124-1870-e053-2995a90a49f82025-02-10WarningsName fallback
generic name: PROGESTERONE
PROGESTERONEPROGESTERONEDirect Rxdc9e2088-e11e-7d32-e053-2a95a90a29952025-01-22WarningsName fallback
generic name: PROGESTERONE
PROGESTERONEPROGESTERONEdirect rxc33e6c10-3149-57c3-e053-2995a90a3fa12025-01-20Boxed warning, Warnings, Adverse reactionsName fallback
generic name: PROGESTERONE
Progesterone PhenolicPROGESTERONEEnergique, Inc.177c7d38-d133-4e3b-a81e-f6bacd39b1472024-10-29WarningsName fallback
generic name: PROGESTERONE
ProgesteronePROGESTERONEFresenius Kabi USA, LLCa479b395-1e1a-4d2a-8feb-68a15c47225f2024-10-15Warnings, Adverse reactionsName fallback
generic name: PROGESTERONE
ProgesteronePROGESTERONEBryant Ranch Prepack1220b231-4765-4879-acb8-d7887d863a282024-07-15Boxed warning, Warnings, Adverse reactionsName fallback
generic name: PROGESTERONE
PROGESTERONEPROGESTERONENuCare Pharmaceuticals,Inc.0d976866-81b3-5db8-e063-6294a90a39f92024-07-10Boxed warning, Warnings, Adverse reactionsName fallback
generic name: PROGESTERONE
ProgesteronePROGESTERONEHikma Pharmaceuticals USA Inc.83cfc12e-75d1-4284-bcc3-beadcbd271712024-07-09Warnings, Adverse reactionsName fallback
generic name: PROGESTERONE
ProgesteronePROGESTERONEProficient Rx LP80a63b2b-96be-423d-abbd-13acc802f6da2024-06-01Boxed warning, Warnings, Adverse reactionsName fallback
generic name: PROGESTERONE
CrinonePROGESTERONEAllergan, Inc.75e97aa1-daa4-45f9-b2e2-1a371302914e2024-05-21Warnings, Adverse reactionsName fallback
generic name: PROGESTERONE
ProgesteronePROGESTERONEBryant Ranch Prepack1c71a4b0-1347-498f-8124-f4cb4be27b612024-05-20Boxed warning, Warnings, Adverse reactionsName fallback
generic name: PROGESTERONE
ProgesteronePROGESTERONEBryant Ranch Prepackb74caa23-a5b8-42dd-ab48-4b7a2f015deb2024-05-20Boxed warning, Warnings, Adverse reactionsName fallback
generic name: PROGESTERONE
ProgesteronePROGESTERONEDeseret Biologicals, Inc.ef33af80-5f72-4635-a8ae-f48376efb4512024-03-14WarningsName fallback
generic name: PROGESTERONE
ProgesteronePROGESTERONEDr. Reddys Laboratories, Inc.efded380-02ff-68c9-13e4-47a561ede4402024-03-05Boxed warning, Warnings, Adverse reactionsName fallback
generic name: PROGESTERONE
ProgesteronePROGESTERONEAurobindo Pharma Limited7d73f08d-2de7-44b6-9e44-2d488fe025172024-03-02Boxed warning, Warnings, Adverse reactionsName fallback
generic name: PROGESTERONE
ProgesteronePROGESTERONEA-S Medication Solutions96c59a1c-d562-46dd-868b-b2decdfef3192023-11-28Boxed warning, Warnings, Adverse reactionsName fallback
generic name: PROGESTERONE
ProgesteronePROGESTERONEEugia US LLC7d19df3b-94ed-4681-beae-9caaf137d0142023-09-12Warnings, Adverse reactionsName 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