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 1 of 7 · 139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CelecoxibCELECOXIBMajor Pharmaceuticals3a1eadd5-c0a7-473e-bde0-6b9450d11c952026-09-02Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Celecoxib
generic name: CELECOXIB
CelecoxibCELECOXIBREMEDYREPACK INC.c96509cc-47f4-44f8-9f7e-4e49cc3d53482026-08-28Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Celecoxib
generic name: CELECOXIB
CelecoxibCELECOXIBDirectRxe0f3aacf-df5d-dad7-e053-2995a90ac5eb2026-08-27Warnings, Adverse reactionsName fallback
brand name: Celecoxib
generic name: CELECOXIB
CelecoxibCELECOXIBA-S Medication Solutionse84d67c8-010d-495c-8691-ae16d0698f8d2026-08-25Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Celecoxib
generic name: CELECOXIB
CelecoxibCELECOXIBSt. Mary's Medical Park Pharmacy59f495e8-3cea-9d98-e063-6394a90a89d42026-08-25Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Celecoxib
generic name: CELECOXIB
CelecoxibCELECOXIBDirect_Rx59cca611-c035-da50-e063-6294a90a73f52026-08-24Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Celecoxib
generic name: CELECOXIB
CelecoxibCELECOXIBMullan Pharmaceutical Inc.643e177f-216d-4dfa-824a-7516a488304e2026-08-19Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Celecoxib
generic name: CELECOXIB
CelecoxibCELECOXIBREMEDYREPACK INC.b3acbfd9-a1c2-4aa6-b5f0-013cfad6cca82026-08-17Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Celecoxib
generic name: CELECOXIB
CelecoxibCELECOXIBREMEDYREPACK INC.e18d2fa4-4982-4e2a-af55-4319d6416efb2026-08-14Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Celecoxib
generic name: CELECOXIB
CELECOXIBCELECOXIBAmerican Health Packaging4af52ae3-6b9d-4bc9-ad6b-c983e4c9dcc72026-08-14Boxed warning, Warnings, Adverse reactionsName fallback
brand name: CELECOXIB
generic name: CELECOXIB
CelecoxibCELECOXIBA-S Medication Solutionsd799328f-9ea0-4b64-9667-8feaa97f150c2026-08-07Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Celecoxib
generic name: CELECOXIB
CelecoxibCELECOXIBPD-Rx Pharmaceuticals, Inc.b06ced10-81c6-4f48-a205-1e0db228cb8b2026-08-03Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Celecoxib
generic name: CELECOXIB
CelecoxibCELECOXIBAlembic Pharmaceuticals Inc.806e5f8a-f986-4f88-ba3e-8265f86afa482026-07-31Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Celecoxib
generic name: CELECOXIB
CelecoxibCELECOXIBSt. Mary's Medical Park Pharmacy57b07096-6d7c-1653-e063-6294a90aa6e22026-07-24Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Celecoxib
generic name: CELECOXIB
CELECOXIBCELECOXIBREMEDYREPACK INC.27f17ae7-939b-402e-9498-3b66111040892026-07-21Boxed warning, Warnings, Adverse reactionsName fallback
brand name: CELECOXIB
generic name: CELECOXIB
CelecoxibCELECOXIBPD-Rx Pharmaceuticals, Inc.06076494-62ad-4f58-b8bb-7038fcfe3b122026-07-17Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Celecoxib
generic name: CELECOXIB
CelecoxibCELECOXIBSt. Mary's Medical Park Pharmacy3bc74e76-0517-69c6-e063-6394a90abe752026-07-17Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Celecoxib
generic name: CELECOXIB
CelecoxibCELECOXIBCardinal Health 107, LLCa9114d6a-13d7-443c-be44-7866b4a4cf962026-07-10Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Celecoxib
generic name: CELECOXIB
celecoxibCELECOXIBHAWAII REPACK, INC.45816eae-ad83-4d2f-a035-c3f9f24708f92026-07-09Boxed warning, Warnings, Adverse reactionsName fallback
brand name: celecoxib
generic name: CELECOXIB
CelecoxibCELECOXIBHAWAII REPACK, INC.77f3b90b-a25d-4c47-975a-2a988d696a3f2026-07-09Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Celecoxib
generic name: CELECOXIB