Application 202825

Type
ANDA
Sponsor
ACCORD HLTHCARE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDETABLET;ORALEQ 25MG BASENoNo
002SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDETABLET;ORALEQ 50MG BASENoNo
003SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDETABLET;ORALEQ 100MG BASENoNo

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
A202825-001SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2014-11-07
A202825-002SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2014-11-07
A202825-003SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2014-11-07

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A202825-001AB
A202825-002AB
A202825-003AB

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 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A202825-001SERTRALINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2014-11-0784e616aacf4f…
2026-09-14 22:38:342026-08A202825-002SERTRALINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2014-11-0784e616aacf4f…
2026-09-14 22:38:342026-08A202825-003SERTRALINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2014-11-0784e616aacf4f…
2026-08-18 06:07:402026-07A202825-001SERTRALINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2014-11-07caaa826d4ba7…
2026-08-18 06:07:402026-07A202825-002SERTRALINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2014-11-07caaa826d4ba7…
2026-08-18 06:07:402026-07A202825-003SERTRALINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2014-11-07caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A202825-001SERTRALINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2014-11-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202825-002SERTRALINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2014-11-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202825-003SERTRALINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2014-11-07011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202825-001SERTRALINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2014-11-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202825-002SERTRALINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2014-11-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202825-003SERTRALINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2014-11-0731067a03dcf5…
2025-08-23 18:47 UTC2025-08A202825-001SERTRALINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2014-11-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202825-002SERTRALINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2014-11-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202825-003SERTRALINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2014-11-076a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202825-001SERTRALINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2014-11-07fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202825-002SERTRALINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2014-11-07fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202825-003SERTRALINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2014-11-07fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202825-001SERTRALINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2014-11-07b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202825-002SERTRALINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2014-11-07b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202825-003SERTRALINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2014-11-07b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202825-001SERTRALINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2014-11-0703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202825-002SERTRALINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2014-11-0703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202825-003SERTRALINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2014-11-0703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202825-001SERTRALINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2014-11-072680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202825-002SERTRALINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2014-11-072680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202825-003SERTRALINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2014-11-072680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202825-001SERTRALINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2014-11-075bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202825-002SERTRALINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2014-11-075bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202825-003SERTRALINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2014-11-075bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202825-001SERTRALINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2014-11-07d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202825-002SERTRALINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2014-11-07d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202825-003SERTRALINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2014-11-07d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A202825-001SERTRALINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2014-11-07d06236e962d9…
2024-10-29 15:01 UTC2024-10A202825-002SERTRALINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2014-11-07d06236e962d9…
2024-10-29 15:01 UTC2024-10A202825-003SERTRALINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2014-11-07d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202825-001SERTRALINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2014-11-0779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202825-002SERTRALINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2014-11-0779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202825-003SERTRALINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2014-11-0779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202825-001SERTRALINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2014-11-07301d65b070ca…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A202825-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A202825-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A202825-003AB184e616aacf4f…
2026-08-18 06:07:402026-07A202825-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A202825-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A202825-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A202825-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202825-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202825-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202825-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202825-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202825-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A202825-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202825-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202825-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202825-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202825-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202825-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202825-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202825-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202825-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202825-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202825-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202825-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202825-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202825-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202825-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202825-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202825-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202825-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202825-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202825-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202825-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A202825-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A202825-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A202825-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202825-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202825-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202825-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202825-001AB1301d65b070ca…

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 1 · 11 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDEBryant Ranch Prepacke919f195-0ce1-4d71-9883-efec05b9a0502026-06-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202825
application number: ANDA202825
ndc (product): 71335-1078
SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDESt. Mary's Medical Park Pharmacy730448bf-2d78-44a4-e053-2991aa0ada9e2026-06-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202825
application number: ANDA202825
SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDEBryant Ranch Prepack5e91adad-9757-49e4-a3f1-1db0ef3964162026-05-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202825
application number: ANDA202825
ndc (product): 71335-0510
SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.aa13261f-46a7-4381-8084-b3ad46221e2f2026-05-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202825
application number: ANDA202825
SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDEAccord Healthcare, Inc.205ecf52-8138-44a7-ad9a-b3aa7f4fa11a2025-12-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202825
application number: ANDA202825
SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDEQPharma, Inc.dc97a895-8c2f-4891-85f3-7f45e23961402025-12-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202825
application number: ANDA202825
SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDEPreferred Pharmaceuticals Inc.2beb45ca-0ebb-4908-807a-7413250693e32025-09-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202825
application number: ANDA202825
SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDEBryant Ranch Prepack82a44e20-d0ee-4ed7-9234-24ef4496ac1d2024-04-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202825
application number: ANDA202825
ndc (product): 71335-0415
SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDEA-S Medication Solutions14c4fa96-8919-4ea7-ad72-129f288d8cfc2023-05-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202825
application number: ANDA202825
SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC68c94fb4-3018-44af-b982-2b4b6d461e6f2022-06-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202825
application number: ANDA202825
ndc (product): 71610-651
SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDEProficient Rx LP6b532e6a-b040-4a10-a242-fb6d8dfc08522019-11-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202825
application number: ANDA202825
ndc (product): 71205-028
ndc (product): 71205-047

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 2 of 2 · 105 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
70518-1615SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDEREMEDYREPACK INC.ANDACurrent
70518-1615SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDEREMEDYREPACK INC.ANDACurrent
70518-2706SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDEREMEDYREPACK INC.ANDACurrent
70518-2706SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDEREMEDYREPACK INC.ANDACurrent
70518-2706SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDEREMEDYREPACK INC.ANDACurrent
70518-3145SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDEREMEDYREPACK INC.ANDACurrent
70518-3145SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDEREMEDYREPACK INC.ANDACurrent
70934-169SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDEDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-169SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDEDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-169SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDEDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
71205-028SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDEProficient Rx LPANDACurrent
71205-028SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDEProficient Rx LPANDACurrent
71205-047SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDEProficient Rx LPANDACurrent
71205-047SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDEProficient Rx LPANDACurrent
71335-0415SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDEBryant Ranch PrepackANDACurrent
71335-0415SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDEBryant Ranch PrepackANDACurrent
71335-0415SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDEBryant Ranch PrepackANDACurrent
71335-0510SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDEBryant Ranch PrepackANDACurrent
71335-0510SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDEBryant Ranch PrepackANDACurrent
71335-0510SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDEBryant Ranch PrepackANDACurrent
71335-1078SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDEBryant Ranch PrepackANDACurrent
71335-1078SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDEBryant Ranch PrepackANDACurrent
71335-1078SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDEBryant Ranch PrepackANDACurrent
71610-651SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLCANDACurrent
71610-651SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLCANDACurrent