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 4 of 7 · 135 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CelecoxibCELECOXIBAlembic Pharmaceuticals Limited14e8d788-e44c-4a40-8678-25cf45fed4772025-09-18Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Celecoxib
generic name: CELECOXIB
CELECOXIBCELECOXIBPHOENIX RX LLC3a669c28-fbc7-827c-e063-6394a90a08292025-08-03Boxed warning, Warnings, Adverse reactionsName fallback
brand name: CELECOXIB
generic name: CELECOXIB
VYSCOXACELECOXIBCarwin Pharmaceutical Associates, LLC5094d47e-f791-4190-9397-b7500143a74d2025-07-31Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CELECOXIB
CelecoxibCELECOXIBPHOENIX RX LLC3a7b127e-c919-418f-e063-6394a90a06d02025-07-21Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Celecoxib
generic name: CELECOXIB
CelecoxibCELECOXIBProficient Rx LP3a450db8-313c-4120-9b8e-58c956323fa42025-06-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Celecoxib
generic name: CELECOXIB
CELECOXIBCELECOXIBA-S Medication Solutions95b2ced1-eca2-4c25-aa10-c9fb86b353a32025-05-30Boxed warning, Warnings, Adverse reactionsName fallback
brand name: CELECOXIB
generic name: CELECOXIB
CELECOXIBCELECOXIBA-S Medication Solutions7b8e923c-253f-461e-94d7-669e75dc73e92025-05-30Boxed warning, Warnings, Adverse reactionsName fallback
brand name: CELECOXIB
generic name: CELECOXIB
celecoxibCELECOXIBBryant Ranch Prepack351f5f07-bdd4-9893-e063-6394a90a72812025-05-14Boxed warning, Warnings, Adverse reactionsName fallback
brand name: celecoxib
generic name: CELECOXIB
CELECOXIBCELECOXIBMicro Labs Limited408b30d6-f5c2-4239-b993-d8f77a8e160b2025-05-13Boxed warning, Warnings, Adverse reactionsName fallback
brand name: CELECOXIB
generic name: CELECOXIB
CelecoxibCELECOXIBActavis Pharma, Inc.05224473-27dc-4f6d-a52a-c40a7af2f2f42025-04-30Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Celecoxib
generic name: CELECOXIB
CelecoxibCELECOXIBAsclemed USA, Inc.5d0dcac1-237c-47aa-bcfb-50fa20b5b8382025-04-11Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Celecoxib
generic name: CELECOXIB
CELECOXIBCELECOXIBPD-Rx Pharmaceuticals, Inc.3191c9dc-bfdf-0591-e054-00144ff8d46c2025-04-11Boxed warning, Warnings, Adverse reactionsName fallback
brand name: CELECOXIB
generic name: CELECOXIB
celecoxibCELECOXIBRedPharm Drug, Inc.50c29846-3426-0310-e054-00144ff8d46c2025-04-09Boxed warning, Warnings, Adverse reactionsName fallback
brand name: celecoxib
generic name: CELECOXIB
celecoxibCELECOXIBAsclemed USA, Inc.f6291230-7598-407a-aef0-ec1f09277d2a2025-03-27Boxed warning, Warnings, Adverse reactionsName fallback
brand name: celecoxib
generic name: CELECOXIB
CELECOXIBCELECOXIBQuallent Pharmaceuticals Health LLCaaa3a4f5-b281-415f-a08c-e0cefdae2fb52025-03-12Boxed warning, Warnings, Adverse reactionsName fallback
brand name: CELECOXIB
generic name: CELECOXIB
CELECOXIBCELECOXIBCipla USA Inc.d12625b1-2af9-4532-af91-d40b65eeffef2025-03-12Boxed warning, Warnings, Adverse reactionsName fallback
brand name: CELECOXIB
generic name: CELECOXIB
CELECOXIBCELECOXIBNorthStar RxLLCce61a585-5ac0-4185-99eb-a9511cd25a982025-03-12Boxed warning, Warnings, Adverse reactionsName fallback
brand name: CELECOXIB
generic name: CELECOXIB
celecoxibCELECOXIBBryant Ranch Prepackac5c0d72-1bb3-4065-b2f4-5516b08697752025-02-20Boxed warning, Warnings, Adverse reactionsName fallback
brand name: celecoxib
generic name: CELECOXIB
CelecoxibCELECOXIBNCS HealthCare of KY, LLC dba Vangard Labs34bef49c-eca1-4f17-9b1b-55900ac408292025-02-20Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Celecoxib
generic name: CELECOXIB
CelecoxibCELECOXIBBryant Ranch Prepacka9749f00-0307-4842-a95b-9a8b4989df252025-02-03Boxed 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.