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 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
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HYDROCHLORIDEEQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2006-05-19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HYDROCHLORIDEEQ 15MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2006-05-19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HYDROCHLORIDEEQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2006-05-19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 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N021860-001SARAFEMEQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2006-05-1984e616aacf4f…
2026-09-14 22:38:342026-08N021860-002SARAFEMEQ 15MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2006-05-1984e616aacf4f…
2026-09-14 22:38:342026-08N021860-003SARAFEMEQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2006-05-1984e616aacf4f…
2026-08-18 06:07:402026-07N021860-001SARAFEMEQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2006-05-19caaa826d4ba7…
2026-08-18 06:07:402026-07N021860-002SARAFEMEQ 15MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2006-05-19caaa826d4ba7…
2026-08-18 06:07:402026-07N021860-003SARAFEMEQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2006-05-19caaa826d4ba7…
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…

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 2 of 5 · 97 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FluoxetineFLUOXETINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.d26f7450-7650-43df-a63b-1fe2472882a92026-04-28Boxed warning, Warnings, Adverse reactionsName fallback
generic name: FLUOXETINE HYDROCHLORIDE
FluoxetineFLUOXETINE HYDROCHLORIDECoupler LLC5020d0d6-969e-b4cd-e063-6294a90af9d22026-04-23Boxed warning, Warnings, Adverse reactionsName fallback
generic name: FLUOXETINE HYDROCHLORIDE
FluoxetineFLUOXETINE HYDROCHLORIDEPreferred Pharmaceuticals, Inc.ef0fa849-a3a0-45d2-9258-da2d46bee0892026-04-17Boxed warning, Warnings, Adverse reactionsName fallback
generic name: FLUOXETINE HYDROCHLORIDE
FluoxetineFLUOXETINE HYDROCHLORIDEPreferred Pharmaceuticals, Inc.ec608267-9c00-4d5c-a9ed-d89503f93d282026-04-17Boxed warning, Warnings, Adverse reactionsName fallback
generic name: FLUOXETINE HYDROCHLORIDE
FluoxetineFLUOXETINE HYDROCHLORIDEPreferred Pharmaceuticals, Inc.e83e2220-d32a-472c-bd9f-b87d0cf8858f2026-04-17Boxed warning, Warnings, Adverse reactionsName fallback
generic name: FLUOXETINE HYDROCHLORIDE
FluoxetineFLUOXETINE HYDROCHLORIDEREMEDYREPACK INC.d121146e-7439-4169-a421-dab7b882b8aa2026-04-13Boxed warning, Warnings, Adverse reactionsName fallback
generic name: FLUOXETINE HYDROCHLORIDE
FluoxetineFLUOXETINE HYDROCHLORIDEREMEDYREPACK INC.8b8fe00e-7a2f-486b-9b72-465a494d89392026-04-10Boxed warning, Warnings, Adverse reactionsName fallback
generic name: FLUOXETINE HYDROCHLORIDE
FluoxetineFLUOXETINE HYDROCHLORIDERADHA PHARMACEUTICALS, INC.1a07ebe9-3661-4a48-b8af-9b228875166a2026-03-30Boxed warning, Warnings, Adverse reactionsName fallback
generic name: FLUOXETINE HYDROCHLORIDE
FluoxetineFLUOXETINE HYDROCHLORIDEBryant Ranch Prepack3ccada47-7eb9-285d-5059-06afb44661142026-03-20Boxed warning, Warnings, Adverse reactionsName fallback
generic name: FLUOXETINE HYDROCHLORIDE
FluoxetineFLUOXETINE HYDROCHLORIDEBryant Ranch Prepackbb06af33-8ff7-0b02-0029-d628f62e13822026-03-20Boxed warning, Warnings, Adverse reactionsName fallback
generic name: FLUOXETINE HYDROCHLORIDE
FluoxetineFLUOXETINE HYDROCHLORIDEBryant Ranch Prepack77d5c10a-0cfc-4b89-942c-0fb5c67ae4092026-03-19Boxed warning, Warnings, Adverse reactionsName fallback
generic name: FLUOXETINE HYDROCHLORIDE
FluoxetineFLUOXETINE HYDROCHLORIDEA-S Medication Solutions2c56a437-f6bf-4ac8-b1d9-fc8a605a97e72026-02-17Boxed warning, Warnings, Adverse reactionsName fallback
generic name: FLUOXETINE HYDROCHLORIDE
FluoxetineFLUOXETINE HYDROCHLORIDEA-S Medication Solutions3e6b9d55-f9bb-4bf2-bc6c-975cc0d94d232026-02-12Boxed warning, Warnings, Adverse reactionsName fallback
generic name: FLUOXETINE HYDROCHLORIDE
FluoxetineFLUOXETINE HYDROCHLORIDEAurobindo Pharma Limited45454555-7402-41cb-a452-e6a76e04f3872026-01-21Boxed warning, Warnings, Adverse reactionsName fallback
generic name: FLUOXETINE HYDROCHLORIDE
ProzacFLUOXETINE HYDROCHLORIDEDista Products Companyc88f33ed-6dfb-4c5e-bc01-d8e36dd972992026-01-08Boxed warning, Warnings, Adverse reactionsName fallback
generic name: FLUOXETINE HYDROCHLORIDE
Fluoxetine HydrochlorideFLUOXETINE HYDROCHLORIDEANI Pharmaceuticals, Inc.1ffe57c3-6f70-4075-aacb-d87a3990fdea2026-01-05Boxed warning, Warnings, Adverse reactionsName fallback
generic name: FLUOXETINE HYDROCHLORIDE
FluoxetineFLUOXETINE HYDROCHLORIDENorthwind Health Company, LLCda6b9b19-2ea1-9a39-e053-2995a90ad7302026-01-01Boxed warning, Warnings, Adverse reactionsName fallback
generic name: FLUOXETINE HYDROCHLORIDE
FluoxetineFLUOXETINE HYDROCHLORIDENorthwind Health Company, LLCdfae4357-b6f9-9a30-e053-2995a90a26672026-01-01Boxed warning, Warnings, Adverse reactionsName fallback
generic name: FLUOXETINE HYDROCHLORIDE
FluoxetineFLUOXETINE HYDROCHLORIDENorthwind Health Company, LLCaae4e339-5244-f6f9-e053-2995a90a42ce2026-01-01Boxed warning, Warnings, Adverse reactionsName fallback
generic name: FLUOXETINE HYDROCHLORIDE
FluoxetineFLUOXETINE HYDROCHLORIDENorthwind Health Company, LLCab1eec9d-f755-81a2-e053-2a95a90acb3c2026-01-01Boxed warning, Warnings, Adverse reactionsName fallback
generic name: FLUOXETINE 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 · 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