Application 021860

Type
NDA
Sponsor
APIL

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SARAFEMFLUOXETINE HYDROCHLORIDETABLET;ORALEQ 10MG BASEYesNo
002SARAFEMFLUOXETINE HYDROCHLORIDETABLET;ORALEQ 15MG BASEYesNo
003SARAFEMFLUOXETINE HYDROCHLORIDETABLET;ORALEQ 20MG BASEYesYes

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
N021860-001SARAFEMFLUOXETINE HYDROCHLORIDEEQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2006-05-19
N021860-002SARAFEMFLUOXETINE HYDROCHLORIDEEQ 15MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2006-05-19
N021860-003SARAFEMFLUOXETINE HYDROCHLORIDEEQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2006-05-19

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 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N021860-001SARAFEMEQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2006-05-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021860-002SARAFEMEQ 15MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2006-05-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021860-003SARAFEMEQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2006-05-19011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021860-001SARAFEMEQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2006-05-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021860-002SARAFEMEQ 15MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2006-05-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021860-003SARAFEMEQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2006-05-1931067a03dcf5…
2025-08-23 18:47 UTC2025-08N021860-001SARAFEMEQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2006-05-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021860-002SARAFEMEQ 15MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2006-05-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021860-003SARAFEMEQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2006-05-196a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021860-001SARAFEMEQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2006-05-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021860-002SARAFEMEQ 15MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2006-05-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021860-003SARAFEMEQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2006-05-19fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021860-001SARAFEMEQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2006-05-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021860-002SARAFEMEQ 15MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2006-05-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021860-003SARAFEMEQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2006-05-19b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021860-001SARAFEMEQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2006-05-1903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021860-002SARAFEMEQ 15MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2006-05-1903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021860-003SARAFEMEQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2006-05-1903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021860-001SARAFEMEQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2006-05-192680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021860-002SARAFEMEQ 15MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2006-05-192680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021860-003SARAFEMEQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2006-05-192680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021860-001SARAFEMEQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2006-05-195bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021860-002SARAFEMEQ 15MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2006-05-195bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021860-003SARAFEMEQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2006-05-195bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021860-001SARAFEMEQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2006-05-19d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021860-002SARAFEMEQ 15MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2006-05-19d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021860-003SARAFEMEQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2006-05-19d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021860-001SARAFEMEQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2006-05-19d06236e962d9…
2024-10-29 15:01 UTC2024-10N021860-002SARAFEMEQ 15MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2006-05-19d06236e962d9…
2024-10-29 15:01 UTC2024-10N021860-003SARAFEMEQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2006-05-19d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021860-001SARAFEMEQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2006-05-1979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021860-002SARAFEMEQ 15MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2006-05-1979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021860-003SARAFEMEQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2006-05-1979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021860-001SARAFEMEQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2006-05-19301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021860-002SARAFEMEQ 15MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2006-05-19301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021860-003SARAFEMEQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2006-05-19301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021860-001SARAFEMEQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2006-05-191e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021860-002SARAFEMEQ 15MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2006-05-191e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021860-003SARAFEMEQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2006-05-191e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021860-001SARAFEMEQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2006-05-198072bd15b7f6…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12N021860-001AB1174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021860-002AB1174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021860-003AB1174a2ff9319b5…
2021-03-12 10:30 UTC2021-03N021860-001AB115aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N021860-003AB115aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N021860-001AB118869cabd3fbd…
2020-12-22 03:56 UTC2020-12N021860-003AB118869cabd3fbd…
2020-11-12 02:37 UTC2020-11N021860-001AB11c0c555d07b60…
2020-11-12 02:37 UTC2020-11N021860-003AB11c0c555d07b60…
2019-12-14 00:12 UTC2019-12N021860-001AB113f01610625f2…
2019-12-14 00:12 UTC2019-12N021860-002AB113f01610625f2…
2019-12-14 00:12 UTC2019-12N021860-003AB113f01610625f2…
2019-09-15 20:21 UTC2019-09N021860-001AB11b00525d2431f…
2019-09-15 20:21 UTC2019-09N021860-002AB11b00525d2431f…
2019-09-15 20:21 UTC2019-09N021860-003AB11b00525d2431f…
2019-07-19 19:46 UTC2019-07N021860-001AB11ea99ee380514…
2019-07-19 19:46 UTC2019-07N021860-002AB11ea99ee380514…
2019-07-19 19:46 UTC2019-07N021860-003AB11ea99ee380514…

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 5 · 100 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FluoxetineFLUOXETINE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC583c5021-2948-7db4-e063-6294a90ae7dc2026-08-04Boxed warning, Warnings, Adverse reactionsName fallback
generic name: FLUOXETINE HYDROCHLORIDE
fluoxetine hydrochlorideFLUOXETINE HYDROCHLORIDEBryant Ranch Prepackd4043133-38de-4faa-bb76-8fafa59138442026-07-16Boxed warning, Warnings, Adverse reactionsName fallback
generic name: FLUOXETINE HYDROCHLORIDE
fluoxetine hydrochlorideFLUOXETINE HYDROCHLORIDEBryant Ranch Prepacka04a5bed-d051-4bb4-ae20-b09b10d5c1812026-07-16Boxed warning, Warnings, Adverse reactionsName fallback
generic name: FLUOXETINE HYDROCHLORIDE
FluoxetineFLUOXETINE HYDROCHLORIDEAmerican Health Packaging7bee936b-0130-4a6b-a974-956aef5486d92026-07-15Boxed warning, Warnings, Adverse reactionsName fallback
generic name: FLUOXETINE HYDROCHLORIDE
FLUOXETINE HYDROCHLORIDEFLUOXETINE HYDROCHLORIDESun Pharmaceutical Industries, Inc.77b6ae48-8e3a-42e6-9b5a-aeed750861e82026-07-14Boxed warning, Warnings, Adverse reactionsName fallback
generic name: FLUOXETINE HYDROCHLORIDE
fluoxetine hydrochlorideFLUOXETINE HYDROCHLORIDEBryant Ranch Prepackfb0608d9-1ae3-43be-8a20-e9f34e9558622026-07-13Boxed warning, Warnings, Adverse reactionsName fallback
generic name: FLUOXETINE HYDROCHLORIDE
fluoxetine hydrochlorideFLUOXETINE HYDROCHLORIDEBryant Ranch Prepackd5a267cb-08bd-4530-a7a8-2bceddd828e52026-07-13Boxed warning, Warnings, Adverse reactionsName fallback
generic name: FLUOXETINE HYDROCHLORIDE
fluoxetine hydrochlorideFLUOXETINE HYDROCHLORIDEBryant Ranch Prepack72e391aa-1a46-4589-8550-f83ac9241cf12026-07-13Boxed warning, Warnings, Adverse reactionsName fallback
generic name: FLUOXETINE HYDROCHLORIDE
FluoxetineFLUOXETINE HYDROCHLORIDEREMEDYREPACK INC.32afb28a-dc4c-4a7e-9701-1825f805e7df2026-07-03Boxed warning, Warnings, Adverse reactionsName fallback
generic name: FLUOXETINE HYDROCHLORIDE
FluoxetineFLUOXETINE HYDROCHLORIDEREMEDYREPACK INC.20516384-6517-48be-bd6e-718250878a762026-06-25Boxed warning, Warnings, Adverse reactionsName fallback
generic name: FLUOXETINE HYDROCHLORIDE
Fluoxetine hydrochlorideFLUOXETINE HYDROCHLORIDEDr.Reddy's Laboratories Limited887fc670-db67-4cfe-967b-46b38375dae52026-06-22Boxed warning, Warnings, Adverse reactionsName fallback
generic name: FLUOXETINE HYDROCHLORIDE
FluoxetineFLUOXETINE HYDROCHLORIDEBryant Ranch Prepack023cef65-c9c2-4d70-af66-198fb1b577142026-06-19Boxed warning, Warnings, Adverse reactionsName fallback
generic name: FLUOXETINE HYDROCHLORIDE
FluoxetineFLUOXETINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.a5fa64a6-3de3-4e2e-8b92-6d507fb8eee92026-06-05Boxed warning, Warnings, Adverse reactionsName fallback
generic name: FLUOXETINE HYDROCHLORIDE
FluoxetineFLUOXETINE HYDROCHLORIDECoupler LLC5386a140-7c5b-5959-e063-6294a90a2ad02026-06-05Boxed warning, Warnings, Adverse reactionsName fallback
generic name: FLUOXETINE HYDROCHLORIDE
FluoxetineFLUOXETINE HYDROCHLORIDEBryant Ranch Prepack992060ee-fb4e-4c6d-9ffe-30902bc63af22026-06-05Boxed warning, Warnings, Adverse reactionsName fallback
generic name: FLUOXETINE HYDROCHLORIDE
fluoxetine hydrochlorideFLUOXETINE HYDROCHLORIDEPar Health USA, LLC53ac797d-8792-4a8c-9708-d1de3d377e8f2026-06-05Boxed warning, Warnings, Adverse reactionsName fallback
generic name: FLUOXETINE HYDROCHLORIDE
FluoxetineFLUOXETINE HYDROCHLORIDESt. Mary's Medical Park Pharmacya9de93d4-2edc-2838-e053-2995a90a8ed62026-05-22Boxed warning, Warnings, Adverse reactionsName fallback
generic name: FLUOXETINE HYDROCHLORIDE
FluoxetineFLUOXETINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.b7b102f0-17a2-49f7-b898-cb2e0fc71b4d2026-05-05Boxed warning, Warnings, Adverse reactionsName fallback
generic name: FLUOXETINE HYDROCHLORIDE
FluoxetineFLUOXETINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.7d7a196b-91de-4753-8bb6-c6d5c668952d2026-04-29Boxed warning, Warnings, Adverse reactionsName fallback
generic name: FLUOXETINE HYDROCHLORIDE
FluoxetineFLUOXETINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.d26f7450-7650-43df-a63b-1fe2472882a92026-04-28Boxed warning, Warnings, Adverse reactionsName fallback
generic name: FLUOXETINE HYDROCHLORIDE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0430-0210SARAFEMfluoxetine hydrochlorideAllergan, Inc.NDACurrent
0430-0210SARAFEMfluoxetine hydrochlorideAllergan, Inc.NDACurrent
0430-0215SARAFEMfluoxetine hydrochlorideAllergan, Inc.NDACurrent
0430-0220SARAFEMfluoxetine hydrochlorideAllergan, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
68731SUPPL2021-09-23
68678SUPPL2021-09-21
68677SUPPL2021-09-21
46799SUPPL2017-01-11
46798SUPPL2017-01-11
46721SUPPL2017-01-06
45046APPL2016-08-24
45045APPL2016-08-24
16474SUPPL2014-12-03
6324SUPPL2014-12-02
37775SUPPL2013-07-08
37774SUPPL2013-07-08
28729SUPPL2013-07-08
28728SUPPL2013-07-08
28727SUPPL2013-07-08
16473SUPPL2013-07-08
16472SUPPL2013-07-08
6323SUPPL2013-07-08
37773SUPPL2009-04-28
28726SUPPL2009-04-27
42329ORIG2008-09-05
37772SUPPL2007-12-03
28725SUPPL2007-12-03
44157ORIG2007-05-09
28724SUPPL2007-04-09
16471SUPPL2007-04-09
37771ORIG2006-05-22
6322ORIG2006-05-22