Application 076881

Type
ANDA
Sponsor
ACI HEALTHCARE LTD

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
A076881-001SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2007-02-06
A076881-002SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2007-02-06
A076881-003SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2007-02-06

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A076881-001AB
A076881-002AB
A076881-003AB

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 22:38:342026-08A076881-001SERTRALINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2007-02-0684e616aacf4f…
2026-09-14 22:38:342026-08A076881-002SERTRALINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2007-02-0684e616aacf4f…
2026-09-14 22:38:342026-08A076881-003SERTRALINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2007-02-0684e616aacf4f…
2026-08-18 06:07:402026-07A076881-001SERTRALINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2007-02-06caaa826d4ba7…
2026-08-18 06:07:402026-07A076881-002SERTRALINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2007-02-06caaa826d4ba7…
2026-08-18 06:07:402026-07A076881-003SERTRALINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2007-02-06caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A076881-001SERTRALINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2007-02-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076881-002SERTRALINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2007-02-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076881-003SERTRALINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2007-02-06011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076881-001SERTRALINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2007-02-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076881-002SERTRALINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2007-02-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076881-003SERTRALINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2007-02-0631067a03dcf5…
2025-08-23 18:47 UTC2025-08A076881-001SERTRALINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2007-02-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076881-002SERTRALINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2007-02-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076881-003SERTRALINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2007-02-066a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076881-001SERTRALINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2007-02-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076881-002SERTRALINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2007-02-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076881-003SERTRALINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2007-02-06fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076881-001SERTRALINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2007-02-06b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076881-002SERTRALINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2007-02-06b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076881-003SERTRALINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2007-02-06b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076881-001SERTRALINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2007-02-0603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076881-002SERTRALINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2007-02-0603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076881-003SERTRALINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2007-02-0603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076881-001SERTRALINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2007-02-062680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076881-002SERTRALINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2007-02-062680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076881-003SERTRALINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2007-02-062680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076881-001SERTRALINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2007-02-065bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076881-002SERTRALINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2007-02-065bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076881-003SERTRALINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2007-02-065bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076881-001SERTRALINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2007-02-06d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076881-002SERTRALINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2007-02-06d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076881-003SERTRALINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2007-02-06d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076881-001SERTRALINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2007-02-06d06236e962d9…
2024-10-29 15:01 UTC2024-10A076881-002SERTRALINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2007-02-06d06236e962d9…
2024-10-29 15:01 UTC2024-10A076881-003SERTRALINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2007-02-06d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076881-001SERTRALINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2007-02-0679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076881-002SERTRALINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2007-02-0679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076881-003SERTRALINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2007-02-0679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076881-001SERTRALINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2007-02-06301d65b070ca…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 111 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A076881-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A076881-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A076881-003AB184e616aacf4f…
2026-08-18 06:07:402026-07A076881-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A076881-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A076881-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A076881-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076881-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076881-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076881-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076881-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076881-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A076881-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076881-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076881-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076881-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076881-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076881-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076881-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076881-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076881-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076881-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076881-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076881-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076881-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076881-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076881-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076881-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076881-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076881-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076881-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076881-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076881-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076881-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A076881-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A076881-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076881-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076881-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076881-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076881-001AB1301d65b070ca…

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 6 of 7 · 136 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDENorthStar Rx LLC7f144b68-ae90-483c-b030-f6824662a7342024-08-19Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Sertraline Hydrochloride
generic name: SERTRALINE HYDROCHLORIDE
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDEBryant Ranch Prepackc6897cf2-1349-400d-ab22-1e88f097b6932024-08-08Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Sertraline Hydrochloride
generic name: SERTRALINE HYDROCHLORIDE
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDEBryant Ranch Prepack2f81b0c4-9ad9-4dda-8950-70321a8769e42024-08-08Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Sertraline Hydrochloride
generic name: SERTRALINE HYDROCHLORIDE
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDEANI Pharmaceuticals, Inc.dfc9fee6-c032-4994-9f14-5beaf39bb5d52024-07-18Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Sertraline Hydrochloride
generic name: SERTRALINE HYDROCHLORIDE
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDERising Pharma Holdings, Inc.af2c75a3-131e-4bde-83fd-310fd2c011612024-06-21Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Sertraline Hydrochloride
generic name: SERTRALINE HYDROCHLORIDE
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDENuCare Pharmaceuticals,Inc.8e105aeb-6e17-a025-e053-2995a90aba772024-06-18Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Sertraline Hydrochloride
generic name: SERTRALINE HYDROCHLORIDE
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDENuCare Pharmaceuticals,Inc.8e98ee4c-24df-88ce-e053-2a95a90a67132024-06-18Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Sertraline Hydrochloride
generic name: SERTRALINE HYDROCHLORIDE
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDENuCare Pharmaceuticals,Inc.7cadc747-5606-8efe-e053-2991aa0a1d8f2024-06-12Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Sertraline Hydrochloride
generic name: SERTRALINE HYDROCHLORIDE
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDENuCare Pharmaceuticals,Inc.6dd71a5b-1923-54fb-e053-2991aa0a619e2024-06-10Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Sertraline Hydrochloride
generic name: SERTRALINE HYDROCHLORIDE
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDENuCare Pharmaceuticals,Inc.71224928-685a-355c-e053-2995a90a0a5b2024-06-10Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Sertraline Hydrochloride
generic name: SERTRALINE HYDROCHLORIDE
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDEBryant Ranch Prepack5c6c817e-a555-4f55-837d-94458787fcb62024-05-22Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Sertraline Hydrochloride
generic name: SERTRALINE HYDROCHLORIDE
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDEBryant Ranch Prepack22c4b114-5f70-4c64-aa7f-b4169729b8472024-04-05Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Sertraline Hydrochloride
generic name: SERTRALINE HYDROCHLORIDE
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDEBryant Ranch Prepack9bcef7ef-4e2f-4ab9-9c0f-f4956bfdd71b2024-04-04Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Sertraline Hydrochloride
generic name: SERTRALINE HYDROCHLORIDE
SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDEBryant Ranch Prepack82a44e20-d0ee-4ed7-9234-24ef4496ac1d2024-04-03Boxed warning, Warnings, Adverse reactionsName fallback
brand name: SERTRALINE HYDROCHLORIDE
generic name: SERTRALINE HYDROCHLORIDE
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDEAurobindo Pharma Limited01800452-c353-4235-a66a-214048752e742024-03-21Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Sertraline Hydrochloride
generic name: SERTRALINE HYDROCHLORIDE
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDEAurobindo Pharma Limited39a85db1-9e59-4ab0-9e18-36757f019faa2024-02-09Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Sertraline Hydrochloride
generic name: SERTRALINE HYDROCHLORIDE
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDENorthStar Rx LLC9bc362d4-489c-4e7f-915a-3076ff8d132a2024-02-09Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Sertraline Hydrochloride
generic name: SERTRALINE HYDROCHLORIDE
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDEA-S Medication Solutions75a43476-25e0-44c3-bbab-2160041032d12023-12-25Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Sertraline Hydrochloride
generic name: SERTRALINE HYDROCHLORIDE
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDEA-S Medication Solutions626a9271-a268-4194-935d-779377f902f52023-12-05Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Sertraline Hydrochloride
generic name: SERTRALINE HYDROCHLORIDE
SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDEScieGen Pharmaceuticals Inc10b9cae4-b452-4abb-866a-9f9d2568f2122023-11-08Boxed warning, Warnings, Adverse reactionsName fallback
brand name: SERTRALINE HYDROCHLORIDE
generic name: SERTRALINE HYDROCHLORIDE

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 1 of 1 · 9 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
71093-129SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDEACI Healthcare USA, Inc.ANDACurrent
71093-129SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDEACI Healthcare USA, Inc.ANDACurrent
71093-129SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDEACI Healthcare USA, Inc.ANDACurrent
71093-130SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDEACI Healthcare USA, Inc.ANDACurrent
71093-130SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDEACI Healthcare USA, Inc.ANDACurrent
71093-130SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDEACI Healthcare USA, Inc.ANDACurrent
71093-131SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDEACI Healthcare USA, Inc.ANDACurrent
71093-131SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDEACI Healthcare USA, Inc.ANDACurrent
71093-131SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDEACI Healthcare USA, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
44324ORIG2005-08-01