Application 076898

Type
ANDA
Sponsor
TEVA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CELECOXIBCELECOXIBCAPSULE;ORAL50MGNoNo
002CELECOXIBCELECOXIBCAPSULE;ORAL100MGNoNo
003CELECOXIBCELECOXIBCAPSULE;ORAL200MGNoNo
004CELECOXIBCELECOXIBCAPSULE;ORAL400MGNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A076898-001CELECOXIBCELECOXIB50MGCAPSULE / ORALAB2014-05-30
A076898-002CELECOXIBCELECOXIB100MGCAPSULE / ORALAB2014-05-30
A076898-003CELECOXIBCELECOXIB200MGCAPSULE / ORALAB2014-05-30
A076898-004CELECOXIBCELECOXIB400MGCAPSULE / ORALAB2014-05-30

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-productTE code
A076898-001AB
A076898-002AB
A076898-003AB
A076898-004AB

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 1 of 5 · 168 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A076898-001CELECOXIB50MGCAPSULE / ORALAB2014-05-30caaa826d4ba7…
2026-08-18 06:07:402026-07A076898-002CELECOXIB100MGCAPSULE / ORALAB2014-05-30caaa826d4ba7…
2026-08-18 06:07:402026-07A076898-003CELECOXIB200MGCAPSULE / ORALAB2014-05-30caaa826d4ba7…
2026-08-18 06:07:402026-07A076898-004CELECOXIB400MGCAPSULE / ORALAB2014-05-30caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A076898-001CELECOXIB50MGCAPSULE / ORALAB2014-05-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076898-002CELECOXIB100MGCAPSULE / ORALAB2014-05-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076898-003CELECOXIB200MGCAPSULE / ORALAB2014-05-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076898-004CELECOXIB400MGCAPSULE / ORALAB2014-05-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076898-001CELECOXIB50MGCAPSULE / ORALAB2014-05-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076898-002CELECOXIB100MGCAPSULE / ORALAB2014-05-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076898-003CELECOXIB200MGCAPSULE / ORALAB2014-05-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076898-004CELECOXIB400MGCAPSULE / ORALAB2014-05-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08A076898-001CELECOXIB50MGCAPSULE / ORALAB2014-05-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076898-002CELECOXIB100MGCAPSULE / ORALAB2014-05-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076898-003CELECOXIB200MGCAPSULE / ORALAB2014-05-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076898-004CELECOXIB400MGCAPSULE / ORALAB2014-05-306a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076898-001CELECOXIB50MGCAPSULE / ORALAB2014-05-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076898-002CELECOXIB100MGCAPSULE / ORALAB2014-05-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076898-003CELECOXIB200MGCAPSULE / ORALAB2014-05-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076898-004CELECOXIB400MGCAPSULE / ORALAB2014-05-30fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076898-001CELECOXIB50MGCAPSULE / ORALAB2014-05-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076898-002CELECOXIB100MGCAPSULE / ORALAB2014-05-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076898-003CELECOXIB200MGCAPSULE / ORALAB2014-05-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076898-004CELECOXIB400MGCAPSULE / ORALAB2014-05-30b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076898-001CELECOXIB50MGCAPSULE / ORALAB2014-05-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076898-002CELECOXIB100MGCAPSULE / ORALAB2014-05-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076898-003CELECOXIB200MGCAPSULE / ORALAB2014-05-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076898-004CELECOXIB400MGCAPSULE / ORALAB2014-05-3003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076898-001CELECOXIB50MGCAPSULE / ORALAB2014-05-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076898-002CELECOXIB100MGCAPSULE / ORALAB2014-05-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076898-003CELECOXIB200MGCAPSULE / ORALAB2014-05-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076898-004CELECOXIB400MGCAPSULE / ORALAB2014-05-302680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076898-001CELECOXIB50MGCAPSULE / ORALAB2014-05-305bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076898-002CELECOXIB100MGCAPSULE / ORALAB2014-05-305bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076898-003CELECOXIB200MGCAPSULE / ORALAB2014-05-305bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076898-004CELECOXIB400MGCAPSULE / ORALAB2014-05-305bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076898-001CELECOXIB50MGCAPSULE / ORALAB2014-05-30d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076898-002CELECOXIB100MGCAPSULE / ORALAB2014-05-30d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076898-003CELECOXIB200MGCAPSULE / ORALAB2014-05-30d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076898-004CELECOXIB400MGCAPSULE / ORALAB2014-05-30d8e5a09893c0…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 168 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A076898-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A076898-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A076898-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A076898-004AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A076898-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076898-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076898-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076898-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076898-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076898-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076898-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076898-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A076898-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076898-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076898-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076898-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076898-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076898-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076898-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076898-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076898-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076898-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076898-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076898-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076898-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076898-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076898-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076898-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076898-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076898-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076898-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076898-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076898-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076898-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076898-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076898-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076898-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076898-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076898-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076898-004AB1d8e5a09893c0…

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 · 136 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
CelecoxibCELECOXIBSt Mary's Medical Park Pharmacye1ab644d-b668-3cf3-e053-2995a90addb02026-07-08Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Celecoxib
generic name: CELECOXIB
CelecoxibCELECOXIBRadha Pharmaceuticals, Inc.2c86ece8-1cf5-4688-91b1-8aef5d60b7e42026-07-08Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Celecoxib
generic name: CELECOXIB
CelecoxibCELECOXIBBryant Ranch Prepackd94849a7-1831-4319-982c-c6b20dc420382026-06-24Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Celecoxib
generic name: CELECOXIB
CelecoxibCELECOXIBREMEDYREPACK INC.f5d0e5b9-97d8-42a4-a0a0-c09dde7008e62026-06-09Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Celecoxib
generic name: CELECOXIB
celecoxibCELECOXIBPD-Rx Pharmaceuticals, Inc.78d59905-4a78-4d9f-ac29-58790a5b3a922026-06-08Boxed warning, Warnings, Adverse reactionsName fallback
brand name: celecoxib
generic name: CELECOXIB
CELECOXIBCELECOXIBBryant Ranch Prepackfd569104-8243-48fa-8e93-5a08654ad6dd2026-05-22Boxed warning, Warnings, Adverse reactionsName fallback
brand name: CELECOXIB
generic name: CELECOXIB
CelecoxibCELECOXIBRedpharm Drug5250529a-6a03-78a1-e063-6294a90a47f92026-05-21Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Celecoxib
generic name: CELECOXIB
CelecoxibCELECOXIBPD-Rx Pharmaceuticals, Inc.52572bfb-43f0-4b55-b1fd-231a05c8b83e2026-05-21Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Celecoxib
generic name: CELECOXIB

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 42 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0093-7165CelecoxibCelecoxibTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7165CelecoxibCelecoxibTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7165CelecoxibCelecoxibTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7165CelecoxibCelecoxibTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7165CelecoxibCelecoxibTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7165CelecoxibCelecoxibTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7165CelecoxibCelecoxibTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7165CelecoxibCelecoxibTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7166CelecoxibCelecoxibTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7166CelecoxibCelecoxibTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7166CelecoxibCelecoxibTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7166CelecoxibCelecoxibTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7166CelecoxibCelecoxibTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7166CelecoxibCelecoxibTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7166CelecoxibCelecoxibTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7166CelecoxibCelecoxibTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7170CelecoxibCelecoxibTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7170CelecoxibCelecoxibTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7170CelecoxibCelecoxibTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7170CelecoxibCelecoxibTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7170CelecoxibCelecoxibTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7170CelecoxibCelecoxibTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7170CelecoxibCelecoxibTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7170CelecoxibCelecoxibTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7306CelecoxibCelecoxibTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7306CelecoxibCelecoxibTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7306CelecoxibCelecoxibTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7306CelecoxibCelecoxibTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7306CelecoxibCelecoxibTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7306CelecoxibCelecoxibTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7306CelecoxibCelecoxibTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7306CelecoxibCelecoxibTeva Pharmaceuticals USA, Inc.ANDACurrent
42708-016CelecoxibCelecoxibQPharma IncANDACurrent
42708-016CelecoxibCelecoxibQPharma IncANDACurrent
42708-016CelecoxibCelecoxibQPharma IncANDACurrent
43063-660CelecoxibCelecoxibPD-Rx Pharmaceuticals, Inc.ANDACurrent
50436-3982CelecoxibCelecoxibUnit Dose ServicesANDACurrent
60760-208CelecoxibCelecoxibSt. Mary's Medical Park PharmacyANDACurrent
68084-969CelecoxibCelecoxibAmerican Health PackagingANDACurrent
68084-969CelecoxibCelecoxibAmerican Health PackagingANDACurrent
68084-976CelecoxibCelecoxibAmerican Health PackagingANDACurrent
68084-976CelecoxibCelecoxibAmerican Health PackagingANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
8977ORIG2014-06-02