FDA.reportPublic FDA data

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 1.

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A076881-001SERTRALINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2007-02-06a50c72e98297…
2026-08-01 22:54:322026-06A076881-002SERTRALINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2007-02-06a50c72e98297…
2026-08-01 22:54:322026-06A076881-003SERTRALINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2007-02-06a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A076881-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A076881-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A076881-003AB1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 7 · 135 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDEREMEDYREPACK INC.91e24d17-ff0a-449c-9472-b9df74c984562026-07-29Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Sertraline Hydrochloride
generic name: SERTRALINE HYDROCHLORIDE
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDEREMEDYREPACK INC.a2f333af-d37b-4705-ab7a-d363e3186e6e2026-07-24Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Sertraline Hydrochloride
generic name: SERTRALINE HYDROCHLORIDE
Sertraline hydrochlorideSERTRALINE HYDROCHLORIDEREMEDYREPACK INC.9d49e2cb-a852-403d-b92b-e7d3fa88032c2026-07-21Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Sertraline hydrochloride
generic name: SERTRALINE HYDROCHLORIDE
Sertraline hydrochlorideSERTRALINE HYDROCHLORIDEREMEDYREPACK INC.e554537c-9469-4f9a-9157-d5763bb8b7202026-07-21Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Sertraline hydrochloride
generic name: SERTRALINE HYDROCHLORIDE
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDEPreferred Pharmaceuticals Inc.f6346a11-88b9-4425-b08d-a22f19c4ceb42026-07-15Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Sertraline Hydrochloride
generic name: SERTRALINE HYDROCHLORIDE
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDECoupler LLC56442b06-c135-a035-e063-6394a90a171b2026-07-10Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Sertraline Hydrochloride
generic name: SERTRALINE HYDROCHLORIDE
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDEUnit Dose Solutions, Inc.561a8a20-be26-c4f8-e063-6394a90af0722026-07-08Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Sertraline Hydrochloride
generic name: SERTRALINE HYDROCHLORIDE
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDEUnit Dose Solutions, Inc.561e7498-a606-366d-e063-6394a90a1c6a2026-07-08Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Sertraline Hydrochloride
generic name: SERTRALINE HYDROCHLORIDE
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDEUnit Dose Solutions, Inc.55f514c6-f6ec-13ac-e063-6294a90ac9572026-07-06Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Sertraline Hydrochloride
generic name: SERTRALINE HYDROCHLORIDE
Sertraline hydrochlorideSERTRALINE HYDROCHLORIDEBryant Ranch Prepack9c0a7f78-9cac-4e82-b971-f3f9758f8a0c2026-06-25Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Sertraline hydrochloride
generic name: SERTRALINE HYDROCHLORIDE
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDEREMEDYREPACK INC.575da603-b038-421f-9894-6796d9ac33cc2026-06-25Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Sertraline Hydrochloride
generic name: SERTRALINE HYDROCHLORIDE
Sertraline hydrochlorideSERTRALINE HYDROCHLORIDENorthwind Health Company, LLC4ddfd698-3d47-fc0e-e063-6394a90accec2026-06-23Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Sertraline hydrochloride
generic name: SERTRALINE HYDROCHLORIDE
Sertraline hydrochlorideSERTRALINE HYDROCHLORIDECoupler LLC544d1ed1-da06-976d-e063-6394a90afe792026-06-15Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Sertraline hydrochloride
generic name: SERTRALINE HYDROCHLORIDE
SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDEBryant Ranch Prepacke919f195-0ce1-4d71-9883-efec05b9a0502026-06-04Boxed warning, Warnings, Adverse reactionsName fallback
brand name: SERTRALINE HYDROCHLORIDE
generic name: SERTRALINE HYDROCHLORIDE
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDESt. Mary's Medical Park Pharmacy8d444aec-cf33-b769-e053-2995a90a54be2026-06-02Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Sertraline Hydrochloride
generic name: SERTRALINE HYDROCHLORIDE
SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDESt. Mary's Medical Park Pharmacy730448bf-2d78-44a4-e053-2991aa0ada9e2026-06-02Boxed warning, Warnings, Adverse reactionsName fallback
brand name: SERTRALINE HYDROCHLORIDE
generic name: SERTRALINE HYDROCHLORIDE
SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDEBryant Ranch Prepack5e91adad-9757-49e4-a3f1-1db0ef3964162026-05-22Boxed warning, Warnings, Adverse reactionsName fallback
brand name: SERTRALINE HYDROCHLORIDE
generic name: SERTRALINE HYDROCHLORIDE
SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.aa13261f-46a7-4381-8084-b3ad46221e2f2026-05-21Boxed warning, Warnings, Adverse reactionsName fallback
brand name: SERTRALINE HYDROCHLORIDE
generic name: SERTRALINE HYDROCHLORIDE
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDEMajor Pharmaceuticals4cf8d5c8-842b-4e7c-9a99-3f41ef8abbdb2026-05-21Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Sertraline Hydrochloride
generic name: SERTRALINE HYDROCHLORIDE
Sertraline hydrochlorideSERTRALINE HYDROCHLORIDEST. MARY'S MEDICAL PARK PHARMACY1fcd3f6d-a71f-b131-e063-6394a90a4b262026-05-14Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Sertraline hydrochloride
generic name: SERTRALINE HYDROCHLORIDE

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