FDA.reportPublic FDA data

Application 040397

Type
ANDA
Sponsor
EPIC PHARMA LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CARISOPRODOLCARISOPRODOLTABLET;ORAL350MGNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A040397-001CARISOPRODOLCARISOPRODOL350MGTABLET / ORAL2000-09-21

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 2 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-09-29 23:25 UTC2022-09A040397-001CARISOPRODOL350MGTABLET / ORAL2000-09-21e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A040397-001CARISOPRODOL350MGTABLET / ORAL2000-09-21cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A040397-001CARISOPRODOL350MGTABLET / ORAL2000-09-21a50c72e98297…

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 3 · 48 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CarisoprodolCARISOPRODOLREMEDYREPACK INC.b83f7fd1-11e3-4e94-ae53-4637e892b3722026-07-29Warnings, Adverse reactionsName fallback
brand name: Carisoprodol
generic name: CARISOPRODOL
CARISOPRODOLCARISOPRODOLNorthwind Health Company, LLC26e466be-8066-e562-e063-6394a90a9f812026-06-22Warnings, Adverse reactionsName fallback
brand name: CARISOPRODOL
generic name: CARISOPRODOL
CARISOPRODOLCARISOPRODOLSt. Mary's Medical Park Pharmacy94f74800-1f0d-7814-e053-2a95a90a4f632026-06-17Warnings, Adverse reactionsName fallback
brand name: CARISOPRODOL
generic name: CARISOPRODOL
CARISOPRODOLCARISOPRODOLBryant Ranch Prepack269644bf-d32c-48a3-b3eb-1221150ebd222026-06-16Warnings, Adverse reactionsName fallback
brand name: CARISOPRODOL
generic name: CARISOPRODOL
carisoprodolCARISOPRODOLREMEDYREPACK INC.eebb9409-e333-4b9f-8059-6588c35ab5782026-06-05Warnings, Adverse reactionsName fallback
brand name: carisoprodol
generic name: CARISOPRODOL
CARISOPRODOLCARISOPRODOLBryant Ranch Prepack59f6f0e3-fdbd-4788-9944-37edde4b9a3c2026-05-28Warnings, Adverse reactionsName fallback
brand name: CARISOPRODOL
generic name: CARISOPRODOL
CARISOPRODOLCARISOPRODOLBryant Ranch Prepacka3f1343f-1337-4b99-b1ae-4189324ec2e92026-05-28Warnings, Adverse reactionsName fallback
brand name: CARISOPRODOL
generic name: CARISOPRODOL
CARISOPRODOLCARISOPRODOLBryant Ranch Prepack93f909ea-2d2e-4a10-be50-7f33f3e904d42026-05-28Warnings, Adverse reactionsName fallback
brand name: CARISOPRODOL
generic name: CARISOPRODOL
CarisoprodolCARISOPRODOLWestminster Pharmaceuticals, LLCbfb31551-8c57-4360-be3a-f6fbe84a891e2026-03-17Warnings, Adverse reactionsName fallback
brand name: Carisoprodol
generic name: CARISOPRODOL
CARISOPRODOLCARISOPRODOLDirectrxd5cc9f99-59ae-55db-e053-2995a90affb72026-03-06Warnings, Adverse reactionsName fallback
brand name: CARISOPRODOL
generic name: CARISOPRODOL
CARISOPRODOLCARISOPRODOLScieGen Pharmaceuticals, Inc.069ea892-21a6-4703-8dd3-bf19c44064792026-02-27Warnings, Adverse reactionsName fallback
brand name: CARISOPRODOL
generic name: CARISOPRODOL
CarisoprodolCARISOPRODOLA-S Medication Solutions6c15f559-c045-4271-86ef-e001aad39c332026-01-23Warnings, Adverse reactionsName fallback
brand name: Carisoprodol
generic name: CARISOPRODOL
CarisoprodolCARISOPRODOLA-S Medication Solutions88f9b969-4225-49d6-9e4c-8c397ba7b50c2026-01-23Warnings, Adverse reactionsName fallback
brand name: Carisoprodol
generic name: CARISOPRODOL
CarisoprodolCARISOPRODOLDirect_Rx8e9bb49a-8cc3-4390-e053-2a95a90a4e0e2026-01-08Warnings, Adverse reactionsName fallback
brand name: Carisoprodol
generic name: CARISOPRODOL
CarisoprodolCARISOPRODOLChartwell RX, LLCa44a3dfc-a427-4584-a086-4bc0c538b1252025-12-10Warnings, Adverse reactionsName fallback
brand name: Carisoprodol
generic name: CARISOPRODOL
Carisoprodol Tablets, USP, 350 mgCARISOPRODOLBryant Ranch Prepack35a8e0a4-93a3-44e3-903f-4661ee1cffe82025-12-03Warnings, Adverse reactionsName fallback
generic name: CARISOPRODOL
Carisoprodol Tablets, USP, 350 mgCARISOPRODOLBryant Ranch Prepack409b04af-b9fd-4ba5-afa0-3e43466f8d2d2025-12-01Warnings, Adverse reactionsName fallback
generic name: CARISOPRODOL
Carisoprodol Tablets, USP, 350 mgCARISOPRODOLPD-Rx Pharmaceuticals, Inc.1f08f4af-37c2-49b5-a4e3-284414f866fa2025-10-23Warnings, Adverse reactionsName fallback
generic name: CARISOPRODOL
SomaCARISOPRODOLViatris Specialty LLC6297cf20-830a-11dc-94c8-0002a5d5c51b2025-08-29Warnings, Adverse reactionsName fallback
generic name: CARISOPRODOL
CarisoprodolCARISOPRODOLBryant Ranch Prepack8c0c418c-90e2-4b81-a9c0-b131c38ec8742025-07-28Warnings, Adverse reactionsName fallback
brand name: Carisoprodol
generic name: CARISOPRODOL

Reported adverse events (FAERS/openFDA)#

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

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
7646ORIG2000-09-21