Application 076882

Type
ANDA
Sponsor
VIWIT PHARM

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
A076882-001SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2007-02-06
A076882-002SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2007-02-06
A076882-003SERTRALINE 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
A076882-001AB
A076882-002AB
A076882-003AB

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 22:38:342026-08A076882-001SERTRALINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2007-02-0684e616aacf4f…
2026-09-14 22:38:342026-08A076882-002SERTRALINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2007-02-0684e616aacf4f…
2026-09-14 22:38:342026-08A076882-003SERTRALINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2007-02-0684e616aacf4f…
2026-08-18 06:07:402026-07A076882-001SERTRALINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2007-02-06caaa826d4ba7…
2026-08-18 06:07:402026-07A076882-002SERTRALINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2007-02-06caaa826d4ba7…
2026-08-18 06:07:402026-07A076882-003SERTRALINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2007-02-06caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A076882-001SERTRALINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2007-02-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076882-002SERTRALINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2007-02-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076882-003SERTRALINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2007-02-06011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076882-001SERTRALINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2007-02-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076882-002SERTRALINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2007-02-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076882-003SERTRALINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2007-02-0631067a03dcf5…
2025-08-23 18:47 UTC2025-08A076882-001SERTRALINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2007-02-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076882-002SERTRALINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2007-02-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076882-003SERTRALINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2007-02-066a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076882-001SERTRALINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2007-02-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076882-002SERTRALINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2007-02-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076882-003SERTRALINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2007-02-06fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076882-001SERTRALINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2007-02-06b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076882-002SERTRALINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2007-02-06b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076882-003SERTRALINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2007-02-06b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076882-001SERTRALINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2007-02-0603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076882-002SERTRALINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2007-02-0603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076882-003SERTRALINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2007-02-0603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076882-001SERTRALINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2007-02-062680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076882-002SERTRALINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2007-02-062680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076882-003SERTRALINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2007-02-062680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076882-001SERTRALINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2007-02-065bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076882-002SERTRALINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2007-02-065bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076882-003SERTRALINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2007-02-065bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076882-001SERTRALINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2007-02-06d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076882-002SERTRALINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2007-02-06d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076882-003SERTRALINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2007-02-06d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076882-001SERTRALINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2007-02-06d06236e962d9…
2024-10-29 15:01 UTC2024-10A076882-002SERTRALINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2007-02-06d06236e962d9…
2024-10-29 15:01 UTC2024-10A076882-003SERTRALINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2007-02-06d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076882-001SERTRALINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2007-02-0679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076882-002SERTRALINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2007-02-0679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076882-003SERTRALINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2007-02-0679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076882-001SERTRALINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2007-02-06301d65b070ca…

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 22:38:342026-08A076882-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A076882-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A076882-003AB184e616aacf4f…
2026-08-18 06:07:402026-07A076882-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A076882-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A076882-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A076882-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076882-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076882-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076882-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076882-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076882-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A076882-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076882-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076882-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076882-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076882-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076882-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076882-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076882-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076882-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076882-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076882-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076882-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076882-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076882-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076882-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076882-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076882-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076882-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076882-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076882-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076882-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076882-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A076882-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A076882-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076882-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076882-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076882-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076882-001AB1301d65b070ca…

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 5 of 7 · 136 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDEZydus Pharmaceuticals (USA) Inc.23f1c8c5-032c-4ea9-beb0-ca3a614ba4b62025-03-26Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Sertraline Hydrochloride
generic name: SERTRALINE HYDROCHLORIDE
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC30b94d67-0000-a045-e063-6394a90ade322025-03-19Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Sertraline Hydrochloride
generic name: SERTRALINE HYDROCHLORIDE
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC680890b1-bc45-4f50-9aaf-e730ab515b852025-03-06Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Sertraline Hydrochloride
generic name: SERTRALINE HYDROCHLORIDE
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDEAsclemed USA, Inc.e25a13c3-a173-4cc3-99d3-0be43abbc4982025-02-12Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Sertraline Hydrochloride
generic name: SERTRALINE HYDROCHLORIDE
Sertraline hydrochlorideSERTRALINE HYDROCHLORIDECoupler LLC2ce05049-030f-3e8b-e063-6394a90a48852025-01-29Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Sertraline hydrochloride
generic name: SERTRALINE HYDROCHLORIDE
SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDEDIRECT RXab962a5a-fff6-2cf9-e053-2995a90ace0f2025-01-17Boxed warning, Warnings, Adverse reactionsName fallback
brand name: SERTRALINE HYDROCHLORIDE
generic name: SERTRALINE HYDROCHLORIDE
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.c4bad433-623b-402c-b454-d39f19a236272025-01-14Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Sertraline Hydrochloride
generic name: SERTRALINE HYDROCHLORIDE
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.0e5a7b02-3972-47f0-9f49-e958d792beac2025-01-14Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Sertraline Hydrochloride
generic name: SERTRALINE HYDROCHLORIDE
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.ae3be25b-2bde-4142-ad56-920a96ac8f392025-01-13Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Sertraline Hydrochloride
generic name: SERTRALINE HYDROCHLORIDE
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDEAdvanced Rx Pharmacy of Tennessee, LLCec1b68d3-ff55-d0a2-e053-2a95a90a2e0b2024-12-31Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Sertraline Hydrochloride
generic name: SERTRALINE HYDROCHLORIDE
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDEAdvanced Rx Pharmacy of Tennessee, LLCf8c45a99-18ed-0e1f-e053-6394a90a2d522024-12-31Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Sertraline Hydrochloride
generic name: SERTRALINE HYDROCHLORIDE
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDEQuality Care Products LLC25aef6c1-9964-44a1-a905-c37e5c28a3c02024-12-17Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Sertraline Hydrochloride
generic name: SERTRALINE HYDROCHLORIDE
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDEAmerican Health Packaging4e09f580-d612-416c-a4a4-79a4411845b22024-11-19Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Sertraline Hydrochloride
generic name: SERTRALINE HYDROCHLORIDE
Sertraline hydrochlorideSERTRALINE HYDROCHLORIDEA-S Medication Solutionsf705f743-40e9-42bf-88f5-6dd7e5d5ba942024-10-25Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Sertraline hydrochloride
generic name: SERTRALINE HYDROCHLORIDE
Sertraline hydrochlorideSERTRALINE HYDROCHLORIDEA-S Medication Solutions4f6f2412-8085-45bf-be4f-63e44490a34e2024-10-25Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Sertraline hydrochloride
generic name: SERTRALINE HYDROCHLORIDE
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDEBryant Ranch Prepack9f1d5689-3bf1-431c-9ea2-9e37217ecf402024-10-21Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Sertraline Hydrochloride
generic name: SERTRALINE HYDROCHLORIDE
Sertraline HydrochlorideSERTRALINE HYDROCHLORIDEBryant Ranch Prepack4191b929-5bdb-4388-9e4d-fffce55bc3632024-10-18Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Sertraline Hydrochloride
generic name: SERTRALINE HYDROCHLORIDE
Sertraline hydrochlorideSERTRALINE HYDROCHLORIDEMylan Pharmaceuticals Inc.1a58062b-e635-431a-908d-2651c6a4a21c2024-09-15Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Sertraline hydrochloride
generic name: SERTRALINE HYDROCHLORIDE
SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDECamber Pharmaceuticals, Inc.de1f85ac-df1b-4b7b-8e18-48ebdc8b92792024-09-04Boxed warning, Warnings, Adverse reactionsName fallback
brand name: SERTRALINE HYDROCHLORIDE
generic name: SERTRALINE HYDROCHLORIDE
SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDEBryant Ranch Prepackfa260c6c-9f6a-46a3-91ce-5665739d87e72024-08-19Boxed 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 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
42337-201Sertraline Hydrochloridesertraline hydrochlorideViwit Pharmaceutical Co., Ltd.ANDACurrent
42337-202Sertraline Hydrochloridesertraline hydrochlorideViwit Pharmaceutical Co., Ltd.ANDACurrent
42337-203Sertraline Hydrochloridesertraline hydrochlorideViwit Pharmaceutical Co., Ltd.ANDACurrent