Application 205129

Type
ANDA
Sponsor
SCIEGEN PHARMS INC

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 1.

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
A205129-001CELECOXIBCELECOXIB50MGCAPSULE / ORALAB2020-12-03
A205129-002CELECOXIBCELECOXIB100MGCAPSULE / ORALAB2020-12-03
A205129-003CELECOXIBCELECOXIB200MGCAPSULE / ORALAB2020-12-03
A205129-004CELECOXIBCELECOXIB400MGCAPSULE / ORALAB2020-12-03

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A205129-001AB
A205129-002AB
A205129-003AB
A205129-004AB

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 4 · 144 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A205129-001CELECOXIB50MGCAPSULE / ORALAB2020-12-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205129-002CELECOXIB100MGCAPSULE / ORALAB2020-12-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205129-003CELECOXIB200MGCAPSULE / ORALAB2020-12-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205129-004CELECOXIB400MGCAPSULE / ORALAB2020-12-03011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205129-001CELECOXIB50MGCAPSULE / ORALAB2020-12-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205129-002CELECOXIB100MGCAPSULE / ORALAB2020-12-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205129-003CELECOXIB200MGCAPSULE / ORALAB2020-12-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205129-004CELECOXIB400MGCAPSULE / ORALAB2020-12-0331067a03dcf5…
2025-08-23 18:47 UTC2025-08A205129-001CELECOXIB50MGCAPSULE / ORALAB2020-12-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205129-002CELECOXIB100MGCAPSULE / ORALAB2020-12-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205129-003CELECOXIB200MGCAPSULE / ORALAB2020-12-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205129-004CELECOXIB400MGCAPSULE / ORALAB2020-12-036a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205129-001CELECOXIB50MGCAPSULE / ORALAB2020-12-03fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205129-002CELECOXIB100MGCAPSULE / ORALAB2020-12-03fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205129-003CELECOXIB200MGCAPSULE / ORALAB2020-12-03fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205129-004CELECOXIB400MGCAPSULE / ORALAB2020-12-03fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205129-001CELECOXIB50MGCAPSULE / ORALAB2020-12-03b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205129-002CELECOXIB100MGCAPSULE / ORALAB2020-12-03b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205129-003CELECOXIB200MGCAPSULE / ORALAB2020-12-03b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205129-004CELECOXIB400MGCAPSULE / ORALAB2020-12-03b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205129-001CELECOXIB50MGCAPSULE / ORALAB2020-12-0303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205129-002CELECOXIB100MGCAPSULE / ORALAB2020-12-0303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205129-003CELECOXIB200MGCAPSULE / ORALAB2020-12-0303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205129-004CELECOXIB400MGCAPSULE / ORALAB2020-12-0303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205129-001CELECOXIB50MGCAPSULE / ORALAB2020-12-032680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205129-002CELECOXIB100MGCAPSULE / ORALAB2020-12-032680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205129-003CELECOXIB200MGCAPSULE / ORALAB2020-12-032680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205129-004CELECOXIB400MGCAPSULE / ORALAB2020-12-032680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205129-001CELECOXIB50MGCAPSULE / ORALAB2020-12-035bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205129-002CELECOXIB100MGCAPSULE / ORALAB2020-12-035bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205129-003CELECOXIB200MGCAPSULE / ORALAB2020-12-035bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205129-004CELECOXIB400MGCAPSULE / ORALAB2020-12-035bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205129-001CELECOXIB50MGCAPSULE / ORALAB2020-12-03d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205129-002CELECOXIB100MGCAPSULE / ORALAB2020-12-03d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205129-003CELECOXIB200MGCAPSULE / ORALAB2020-12-03d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205129-004CELECOXIB400MGCAPSULE / ORALAB2020-12-03d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A205129-001CELECOXIB50MGCAPSULE / ORALAB2020-12-03d06236e962d9…
2024-10-29 15:01 UTC2024-10A205129-002CELECOXIB100MGCAPSULE / ORALAB2020-12-03d06236e962d9…
2024-10-29 15:01 UTC2024-10A205129-003CELECOXIB200MGCAPSULE / ORALAB2020-12-03d06236e962d9…
2024-10-29 15:01 UTC2024-10A205129-004CELECOXIB400MGCAPSULE / ORALAB2020-12-03d06236e962d9…

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 4 · 144 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A205129-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A205129-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A205129-003AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A205129-004AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A205129-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A205129-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A205129-003AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A205129-004AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A205129-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A205129-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A205129-003AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A205129-004AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A205129-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A205129-002AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A205129-003AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A205129-004AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A205129-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A205129-002AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A205129-003AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A205129-004AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A205129-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A205129-002AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A205129-003AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A205129-004AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A205129-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A205129-002AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A205129-003AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A205129-004AB14b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A205129-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A205129-002AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A205129-003AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A205129-004AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A205129-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A205129-002AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A205129-003AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A205129-004AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A205129-001AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A205129-002AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A205129-003AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A205129-004AB187673890dc5c…

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 2 · 24 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CelecoxibCELECOXIBPD-Rx Pharmaceuticals, Inc.06076494-62ad-4f58-b8bb-7038fcfe3b122026-07-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205129
application number: ANDA205129
ndc (product): 72789-259
CelecoxibCELECOXIBHAWAII REPACK, INC.77f3b90b-a25d-4c47-975a-2a988d696a3f2026-07-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205129
application number: ANDA205129
CelecoxibCELECOXIBSt Mary's Medical Park Pharmacye1ab644d-b668-3cf3-e053-2995a90addb02026-07-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205129
application number: ANDA205129
ndc (product): 60760-742
CelecoxibCELECOXIBRadha Pharmaceuticals, Inc.2c86ece8-1cf5-4688-91b1-8aef5d60b7e42026-07-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205129
application number: ANDA205129
ndc (product): 77771-158
ndc (product): 77771-156
ndc (product): 77771-157
ndc (product): 77771-159
CelecoxibCELECOXIBST. MARY'S MEDICAL PARK PHARMACYed2093f6-1606-100a-e053-2995a90a5b952026-05-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205129
application number: ANDA205129
ndc (product): 60760-649
CelecoxibCELECOXIBREMEDYREPACK INC.56127f57-7810-4f5d-a11d-e08fb2ed138b2026-04-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205129
application number: ANDA205129
CelecoxibCELECOXIBREMEDYREPACK INC.b3acbfd9-a1c2-4aa6-b5f0-013cfad6cca82026-04-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205129
application number: ANDA205129
CelecoxibCELECOXIBPreferred Pharmaceuticals, Inc.f2a5ffbd-49c4-4a97-867b-2b14a36750202026-03-25Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205129
application number: ANDA205129
ndc (product): 68788-8197
CelecoxibCELECOXIBPreferred Pharmaceuticals, Inc.d35d9494-4190-41a8-80d4-c9d877c432e92026-03-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205129
application number: ANDA205129
CelecoxibCELECOXIBScieGen Pharmaceuticals, Inc.8709cbe7-3de1-4908-a0a9-53002bcee15b2026-03-12Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205129
application number: ANDA205129
ndc (product): 50228-159
ndc (product): 50228-156
ndc (product): 50228-157
ndc (product): 50228-158
CelecoxibCELECOXIBSportpharm LLC528a6f12-9878-4005-8fc2-5997adbb287f2026-02-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205129
application number: ANDA205129
CelecoxibCELECOXIBPHOENIX RX LLC3a7b127e-c919-418f-e063-6394a90a06d02025-07-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205129
application number: ANDA205129
CelecoxibCELECOXIBAsclemed USA, Inc.5d0dcac1-237c-47aa-bcfb-50fa20b5b8382025-04-11Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205129
application number: ANDA205129
CelecoxibCELECOXIBDirectRxe0f3aacf-df5d-dad7-e053-2995a90ac5eb2025-01-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205129
application number: ANDA205129
ndc (product): 72189-360
CelecoxibCELECOXIBQuality Care Products, LLCfcf49d7f-8319-4051-b7ac-fe063268b39b2024-12-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205129
application number: ANDA205129
CelecoxibCELECOXIBBryant Ranch Prepack0d89c39e-4858-4255-9127-1366e005203c2024-12-11Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205129
application number: ANDA205129
CelecoxibCELECOXIBBryant Ranch Prepack0dc9020d-28f5-4c69-896c-87b38e3ddb882024-12-11Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205129
application number: ANDA205129
CelecoxibCELECOXIBBryant Ranch Prepack8a1e9a52-4627-4098-8a11-25e92ad960232024-11-07Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205129
application number: ANDA205129
CelecoxibCELECOXIBNuCare Pharmaceuticals,Inc.dfdc74e8-1e4e-53e1-e053-2995a90abc522024-08-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205129
application number: ANDA205129
ndc (product): 68071-2733
CelecoxibCELECOXIBAdvanced Rx Pharmacy of Tennessee, LLC15d6ef4f-568d-9d3e-e063-6294a90ab04c2024-04-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205129
application number: ANDA205129

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 50 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50228-156CelecoxibCelecoxibScieGen Pharmaceuticals, Inc.ANDACurrent
50228-156CelecoxibCelecoxibScieGen Pharmaceuticals, Inc.ANDACurrent
50228-156CelecoxibCelecoxibScieGen Pharmaceuticals, Inc.ANDACurrent
50228-156CelecoxibCelecoxibScieGen Pharmaceuticals, Inc.ANDACurrent
50228-157CelecoxibCelecoxibScieGen Pharmaceuticals, Inc.ANDACurrent
50228-157CelecoxibCelecoxibScieGen Pharmaceuticals, Inc.ANDACurrent
50228-157CelecoxibCelecoxibScieGen Pharmaceuticals, Inc.ANDACurrent
50228-157CelecoxibCelecoxibScieGen Pharmaceuticals, Inc.ANDACurrent
50228-158CelecoxibCelecoxibScieGen Pharmaceuticals, Inc.ANDACurrent
50228-158CelecoxibCelecoxibScieGen Pharmaceuticals, Inc.ANDACurrent
50228-158CelecoxibCelecoxibScieGen Pharmaceuticals, Inc.ANDACurrent
50228-158CelecoxibCelecoxibScieGen Pharmaceuticals, Inc.ANDACurrent
50228-159CelecoxibCelecoxibScieGen Pharmaceuticals, Inc.ANDACurrent
50228-159CelecoxibCelecoxibScieGen Pharmaceuticals, Inc.ANDACurrent
50228-159CelecoxibCelecoxibScieGen Pharmaceuticals, Inc.ANDACurrent
50228-159CelecoxibCelecoxibScieGen Pharmaceuticals, Inc.ANDACurrent
60760-649CelecoxibCelecoxibST. MARY'S MEDICAL PARK PHARMACYANDACurrent
60760-742CelecoxibCelecoxibSt Mary's Medical Park PharmacyANDACurrent
60760-742CelecoxibCelecoxibSt Mary's Medical Park PharmacyANDACurrent
60760-742CelecoxibCelecoxibSt Mary's Medical Park PharmacyANDACurrent
68071-2733CelecoxibCelecoxibNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2776CelecoxibCelecoxibNuCare Pharmaceuticals,Inc.ANDACurrent
68788-8197CelecoxibCelecoxibPreferred Pharmaceuticals, Inc.ANDACurrent
71205-664CelecoxibCelecoxibProficient Rx LPANDACurrent
71610-584CelecoxibCelecoxibAphena Pharma Solutions - Tennessee, LLCANDACurrent
72189-360CelecoxibCelecoxibDirectRxANDACurrent
72789-259CelecoxibCelecoxibPD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-259CelecoxibCelecoxibPD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-259CelecoxibCelecoxibPD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-259CelecoxibCelecoxibPD-Rx Pharmaceuticals, Inc.ANDACurrent
77771-156CelecoxibCelecoxibRadha Pharmaceuticals, Inc.ANDACurrent
77771-156CelecoxibCelecoxibRadha Pharmaceuticals, Inc.ANDACurrent
77771-156CelecoxibCelecoxibRadha Pharmaceuticals, Inc.ANDACurrent
77771-156CelecoxibCelecoxibRadha Pharmaceuticals, Inc.ANDACurrent
77771-156CelecoxibCelecoxibRadha Pharmaceuticals, Inc.ANDACurrent
77771-157CelecoxibCelecoxibRadha Pharmaceuticals, Inc.ANDACurrent
77771-157CelecoxibCelecoxibRadha Pharmaceuticals, Inc.ANDACurrent
77771-157CelecoxibCelecoxibRadha Pharmaceuticals, Inc.ANDACurrent
77771-157CelecoxibCelecoxibRadha Pharmaceuticals, Inc.ANDACurrent
77771-157CelecoxibCelecoxibRadha Pharmaceuticals, Inc.ANDACurrent
77771-158CelecoxibCelecoxibRadha Pharmaceuticals, Inc.ANDACurrent
77771-158CelecoxibCelecoxibRadha Pharmaceuticals, Inc.ANDACurrent
77771-158CelecoxibCelecoxibRadha Pharmaceuticals, Inc.ANDACurrent
77771-158CelecoxibCelecoxibRadha Pharmaceuticals, Inc.ANDACurrent
77771-158CelecoxibCelecoxibRadha Pharmaceuticals, Inc.ANDACurrent
77771-159CelecoxibCelecoxibRadha Pharmaceuticals, Inc.ANDACurrent
77771-159CelecoxibCelecoxibRadha Pharmaceuticals, Inc.ANDACurrent
77771-159CelecoxibCelecoxibRadha Pharmaceuticals, Inc.ANDACurrent
77771-159CelecoxibCelecoxibRadha Pharmaceuticals, Inc.ANDACurrent
77771-159CelecoxibCelecoxibRadha Pharmaceuticals, Inc.ANDACurrent