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 7 of 7 · 135 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
celecoxibCELECOXIBAsclemed USA, Inc.2a926010-08e1-44dd-bc6d-ed15374bd0d32023-09-02Boxed warning, Warnings, Adverse reactionsName fallback
brand name: celecoxib
generic name: CELECOXIB
CELECOXIBCELECOXIBA-S Medication Solutions00e67d5e-df6f-4dfd-8c2d-a001c8a99af02023-08-24Boxed warning, Warnings, Adverse reactionsName fallback
brand name: CELECOXIB
generic name: CELECOXIB
CelecoxibCELECOXIBA-S Medication Solutionsdea035a6-dcf1-4b7d-8adc-a2f678b71fd92023-08-06Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Celecoxib
generic name: CELECOXIB
CelecoxibCELECOXIBProficient Rx LPb9a7f32c-8136-4f29-be6b-4d5e904ca0f12023-05-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Celecoxib
generic name: CELECOXIB
CELECOXIBCELECOXIBA-S Medication Solutionsc7a183dc-f4d5-483f-964c-f2745a3640ad2023-02-28Boxed warning, Warnings, Adverse reactionsName fallback
brand name: CELECOXIB
generic name: CELECOXIB
celecoxibCELECOXIBA-S Medication Solutions85bfe02b-bfcb-44ee-81a0-11765c3054a92023-02-06Boxed warning, Warnings, Adverse reactionsName fallback
brand name: celecoxib
generic name: CELECOXIB
celecoxibCELECOXIBProficient Rx LP0ad14a4e-2f05-4ce7-93d1-1cb7e4d8f7d02022-08-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: celecoxib
generic name: CELECOXIB
celecoxibCELECOXIBProficient Rx LPcbd2d6de-6f0d-4b69-8e27-a1fe08830ba52022-04-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: celecoxib
generic name: CELECOXIB
CelecoxibCELECOXIBTianjin Tianyao Pharmaceuticals Co., Ltd.76f9bcb7-0e94-485f-816d-61d4e1ed24e02022-02-28Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Celecoxib
generic name: CELECOXIB
CelecoxibCELECOXIBAphena Pharma Solutions - Tennessee, LLCd258e065-e9a6-44e2-89c9-6892d771d9d32021-08-09Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Celecoxib
generic name: CELECOXIB
CELECOXIBCELECOXIBProficient Rx LPc91e5933-1798-4096-9f08-fb1200e154e12021-01-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: CELECOXIB
generic name: CELECOXIB
CelecoxibCELECOXIBProficient Rx LP6dd743d3-4821-4919-90eb-6d306ca7999f2021-01-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Celecoxib
generic name: CELECOXIB
Celecoxib 200 mgCELECOXIBProficient Rx LPfeee6a01-63f9-42c3-8bd8-ca713a08b36d2019-11-01Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CELECOXIB
CelecoxibCELECOXIBProficient Rx LP7a234c0c-30a7-49f5-92a1-a1fc836ff9ae2019-10-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Celecoxib
generic name: CELECOXIB
CelecoxibCELECOXIBProficient Rx LPc787b0ab-77ab-4f7e-9fea-be2a0085020a2019-10-01Boxed 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.