FDA.reportPublic FDA data

Application 213127

Type
ANDA
Sponsor
STRIDES PHARMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CELECOXIBCELECOXIBCAPSULE;ORAL100MGNoNo
002CELECOXIBCELECOXIBCAPSULE;ORAL200MGNoNo
003CELECOXIBCELECOXIBCAPSULE;ORAL400MGNoNo

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A213127-001CELECOXIBCELECOXIB100MGCAPSULE / ORAL2025-04-29
A213127-002CELECOXIBCELECOXIB200MGCAPSULE / ORAL2025-04-29
A213127-003CELECOXIBCELECOXIB400MGCAPSULE / ORAL2025-04-29

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A213127-001CELECOXIB100MGCAPSULE / ORAL2025-04-2984e616aacf4f…
2026-09-14 22:38:342026-08A213127-002CELECOXIB200MGCAPSULE / ORAL2025-04-2984e616aacf4f…
2026-09-14 22:38:342026-08A213127-003CELECOXIB400MGCAPSULE / ORAL2025-04-2984e616aacf4f…
2026-08-18 06:07:402026-07A213127-001CELECOXIB100MGCAPSULE / ORAL2025-04-29caaa826d4ba7…
2026-08-18 06:07:402026-07A213127-002CELECOXIB200MGCAPSULE / ORAL2025-04-29caaa826d4ba7…
2026-08-18 06:07:402026-07A213127-003CELECOXIB400MGCAPSULE / ORAL2025-04-29caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A213127-001CELECOXIB100MGCAPSULE / ORAL2025-04-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213127-002CELECOXIB200MGCAPSULE / ORAL2025-04-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213127-003CELECOXIB400MGCAPSULE / ORAL2025-04-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213127-001CELECOXIB100MGCAPSULE / ORAL2025-04-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213127-002CELECOXIB200MGCAPSULE / ORAL2025-04-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213127-003CELECOXIB400MGCAPSULE / ORAL2025-04-2931067a03dcf5…
2025-08-23 18:47 UTC2025-08A213127-001CELECOXIB100MGCAPSULE / ORAL2025-04-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213127-002CELECOXIB200MGCAPSULE / ORAL2025-04-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213127-003CELECOXIB400MGCAPSULE / ORAL2025-04-296a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A213127-001CELECOXIB100MGCAPSULE / ORAL2025-04-29a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A213127-002CELECOXIB200MGCAPSULE / ORAL2025-04-29a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A213127-003CELECOXIB400MGCAPSULE / ORAL2025-04-29a50c72e98297…

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 6 of 7 · 135 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CelecoxibCELECOXIBAurobindo Pharma Limited1e811c3a-5653-4617-b958-380802cc443a2024-12-05Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Celecoxib
generic name: CELECOXIB
CelecoxibCELECOXIBCadila Pharmaceuticals Limited78ce3df5-07ee-43bb-9348-104a9524a0322024-12-04Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Celecoxib
generic name: CELECOXIB
CelecoxibCELECOXIBWestminster Pharmaceuticals, LLCcb0be640-067e-4422-9bec-d5fa07175bd02024-12-04Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Celecoxib
generic name: CELECOXIB
ELYXYB - celecoxibCELECOXIBSCILEX PHARMACEUTICALS INC.c8a5de07-9f27-4a54-a885-8089f0307bd72024-11-26Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CELECOXIB
CELEBREXCELECOXIBViatris Specialty LLC2d6675e4-5859-4be2-8037-a20ce9f707aa2024-11-22Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CELECOXIB
CelecoxibCELECOXIBBryant Ranch Prepack1bf407db-8bc6-4aea-8bcc-eaa4c24cb7a62024-11-11Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Celecoxib
generic name: CELECOXIB
CelecoxibCELECOXIBBryant Ranch Prepack8a1e9a52-4627-4098-8a11-25e92ad960232024-11-07Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Celecoxib
generic name: CELECOXIB
CelecoxibCELECOXIBA-S Medication Solutions217265c0-e98e-482c-8af2-f8ac0ab7a0a12024-09-18Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Celecoxib
generic name: CELECOXIB
CELECOXIBCELECOXIBProficient Rx LP1071fcb5-0e9f-4e30-8fb4-df76fd876fe82024-09-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: CELECOXIB
generic name: CELECOXIB
CelecoxibCELECOXIBA-S Medication Solutions85b87dd2-c609-4d69-99eb-0acd852acdaf2024-08-21Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Celecoxib
generic name: CELECOXIB
CELECOXIBCELECOXIBBryant Ranch Prepack627abea5-e39a-4e4f-b1ab-4842ed8112e92024-08-15Boxed warning, Warnings, Adverse reactionsName fallback
brand name: CELECOXIB
generic name: CELECOXIB
CelecoxibCELECOXIBNuCare Pharmaceuticals,Inc.dfdc74e8-1e4e-53e1-e053-2995a90abc522024-08-05Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Celecoxib
generic name: CELECOXIB
CelecoxibCELECOXIBNuCare Pharmaceuticals, Inc.1cbe21c0-3425-9a25-e063-6294a90a0d1d2024-07-08Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Celecoxib
generic name: CELECOXIB
celecoxibCELECOXIBNuCare Pharmaceuticals,Inc.69aebbab-9906-be86-e053-2991aa0aa8a52024-06-10Boxed warning, Warnings, Adverse reactionsName fallback
brand name: celecoxib
generic name: CELECOXIB
CelecoxibCELECOXIBAsclemed USA, Inc.265b50cc-6d99-4ef8-8439-6792e1f21c682024-05-10Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Celecoxib
generic name: CELECOXIB
CelecoxibCELECOXIBAdvanced Rx Pharmacy of Tennessee, LLC15d6ef4f-568d-9d3e-e063-6294a90ab04c2024-04-10Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Celecoxib
generic name: CELECOXIB
CelecoxibCELECOXIBMedsource Pharmaceuticals14962aef-7609-b29a-e063-6394a90a53992024-03-26Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Celecoxib
generic name: CELECOXIB
CelecoxibCELECOXIBBryant Ranch Prepack631154cd-8f61-41b2-a686-80edc711cdaa2024-02-23Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Celecoxib
generic name: CELECOXIB
celecoxibCELECOXIBLupin Pharmaceuticals, Inc.560017b1-daf8-464e-b86f-0a75c78002ec2023-12-08Boxed warning, Warnings, Adverse reactionsName fallback
brand name: celecoxib
generic name: CELECOXIB
CelecoxibCELECOXIBProficient Rx LPc529b321-38ed-434f-b76e-06902cdd40dc2023-12-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Celecoxib
generic name: CELECOXIB

Reported adverse events (FAERS/openFDA)#

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