Application 075245

Type
ANDA
Sponsor
IVAX SUB TEVA PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001FLUOXETINE HYDROCHLORIDEFLUOXETINE HYDROCHLORIDECAPSULE;ORALEQ 20MG BASENoNo
002FLUOXETINE HYDROCHLORIDEFLUOXETINE HYDROCHLORIDECAPSULE;ORALEQ 10MG BASENoNo
003FLUOXETINE HYDROCHLORIDEFLUOXETINE HYDROCHLORIDECAPSULE;ORALEQ 40MG 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
A075245-001FLUOXETINE HYDROCHLORIDEFLUOXETINE HYDROCHLORIDEEQ 20MG BASECAPSULE / ORALAB12002-01-31
A075245-002FLUOXETINE HYDROCHLORIDEFLUOXETINE HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB12002-01-31
A075245-003FLUOXETINE HYDROCHLORIDEFLUOXETINE HYDROCHLORIDEEQ 40MG BASECAPSULE / ORALAB2004-09-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A075245-001AB1
A075245-002AB1
A075245-003AB

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 22:38:342026-08A075245-001FLUOXETINE HYDROCHLORIDEEQ 20MG BASECAPSULE / ORALAB12002-01-3184e616aacf4f…
2026-09-14 22:38:342026-08A075245-002FLUOXETINE HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB12002-01-3184e616aacf4f…
2026-09-14 22:38:342026-08A075245-003FLUOXETINE HYDROCHLORIDEEQ 40MG BASECAPSULE / ORALAB2004-09-2884e616aacf4f…
2026-08-18 06:07:402026-07A075245-001FLUOXETINE HYDROCHLORIDEEQ 20MG BASECAPSULE / ORALAB12002-01-31caaa826d4ba7…
2026-08-18 06:07:402026-07A075245-002FLUOXETINE HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB12002-01-31caaa826d4ba7…
2026-08-18 06:07:402026-07A075245-003FLUOXETINE HYDROCHLORIDEEQ 40MG BASECAPSULE / ORALAB2004-09-28caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A075245-001FLUOXETINE HYDROCHLORIDEEQ 20MG BASECAPSULE / ORALAB12002-01-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075245-002FLUOXETINE HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB12002-01-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075245-003FLUOXETINE HYDROCHLORIDEEQ 40MG BASECAPSULE / ORALAB2004-09-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075245-001FLUOXETINE HYDROCHLORIDEEQ 20MG BASECAPSULE / ORALAB12002-01-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075245-002FLUOXETINE HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB12002-01-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075245-003FLUOXETINE HYDROCHLORIDEEQ 40MG BASECAPSULE / ORALAB2004-09-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08A075245-001FLUOXETINE HYDROCHLORIDEEQ 20MG BASECAPSULE / ORALAB12002-01-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075245-002FLUOXETINE HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB12002-01-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075245-003FLUOXETINE HYDROCHLORIDEEQ 40MG BASECAPSULE / ORALAB2004-09-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075245-001FLUOXETINE HYDROCHLORIDEEQ 20MG BASECAPSULE / ORALAB12002-01-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075245-002FLUOXETINE HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB12002-01-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075245-003FLUOXETINE HYDROCHLORIDEEQ 40MG BASECAPSULE / ORALAB2004-09-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075245-001FLUOXETINE HYDROCHLORIDEEQ 20MG BASECAPSULE / ORALAB12002-01-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075245-002FLUOXETINE HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB12002-01-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075245-003FLUOXETINE HYDROCHLORIDEEQ 40MG BASECAPSULE / ORALAB2004-09-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075245-001FLUOXETINE HYDROCHLORIDEEQ 20MG BASECAPSULE / ORALAB12002-01-3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075245-002FLUOXETINE HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB12002-01-3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075245-003FLUOXETINE HYDROCHLORIDEEQ 40MG BASECAPSULE / ORALAB2004-09-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075245-001FLUOXETINE HYDROCHLORIDEEQ 20MG BASECAPSULE / ORALAB12002-01-312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075245-002FLUOXETINE HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB12002-01-312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075245-003FLUOXETINE HYDROCHLORIDEEQ 40MG BASECAPSULE / ORALAB2004-09-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075245-001FLUOXETINE HYDROCHLORIDEEQ 20MG BASECAPSULE / ORALAB12002-01-315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075245-002FLUOXETINE HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB12002-01-315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075245-003FLUOXETINE HYDROCHLORIDEEQ 40MG BASECAPSULE / ORALAB2004-09-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075245-001FLUOXETINE HYDROCHLORIDEEQ 20MG BASECAPSULE / ORALAB12002-01-31d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075245-002FLUOXETINE HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB12002-01-31d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075245-003FLUOXETINE HYDROCHLORIDEEQ 40MG BASECAPSULE / ORALAB2004-09-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075245-001FLUOXETINE HYDROCHLORIDEEQ 20MG BASECAPSULE / ORALAB12002-01-31d06236e962d9…
2024-10-29 15:01 UTC2024-10A075245-002FLUOXETINE HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB12002-01-31d06236e962d9…
2024-10-29 15:01 UTC2024-10A075245-003FLUOXETINE HYDROCHLORIDEEQ 40MG BASECAPSULE / ORALAB2004-09-28d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075245-001FLUOXETINE HYDROCHLORIDEEQ 20MG BASECAPSULE / ORALAB12002-01-3179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075245-002FLUOXETINE HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB12002-01-3179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075245-003FLUOXETINE HYDROCHLORIDEEQ 40MG BASECAPSULE / ORALAB2004-09-2879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075245-001FLUOXETINE HYDROCHLORIDEEQ 20MG BASECAPSULE / ORALAB12002-01-31301d65b070ca…

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 22:38:342026-08A075245-001AB1184e616aacf4f…
2026-09-14 22:38:342026-08A075245-002AB1184e616aacf4f…
2026-09-14 22:38:342026-08A075245-003AB184e616aacf4f…
2026-08-18 06:07:402026-07A075245-001AB11caaa826d4ba7…
2026-08-18 06:07:402026-07A075245-002AB11caaa826d4ba7…
2026-08-18 06:07:402026-07A075245-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A075245-001AB11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075245-002AB11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075245-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075245-001AB1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075245-002AB1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075245-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A075245-001AB116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075245-002AB116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075245-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075245-001AB11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075245-002AB11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075245-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075245-001AB11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075245-002AB11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075245-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075245-001AB1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075245-002AB1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075245-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075245-001AB112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075245-002AB112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075245-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075245-001AB115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075245-002AB115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075245-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075245-001AB11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075245-002AB11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075245-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075245-001AB11d06236e962d9…
2024-10-29 15:01 UTC2024-10A075245-002AB11d06236e962d9…
2024-10-29 15:01 UTC2024-10A075245-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075245-001AB1179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075245-002AB1179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075245-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075245-001AB11301d65b070ca…

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 4 of 5 · 97 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FluoxetineFLUOXETINE HYDROCHLORIDEBryant Ranch Prepack3d5d03ff-0d0c-429f-b747-31ff3465d39d2024-08-23Boxed warning, Warnings, Adverse reactionsName fallback
generic name: FLUOXETINE HYDROCHLORIDE
FluoxetineFLUOXETINE HYDROCHLORIDEBoswell Pharmacy Services LLC d/b/a BPS Wholesale1fd00b7f-df07-455f-e063-6394a90a1f102024-08-16Boxed warning, Warnings, Adverse reactionsName fallback
generic name: FLUOXETINE HYDROCHLORIDE
FluoxetineFLUOXETINE HYDROCHLORIDEA-S Medication Solutions1226a67f-ec09-42f6-9d1b-9ddd862ea0a02024-08-12Boxed warning, Warnings, Adverse reactionsName fallback
generic name: FLUOXETINE HYDROCHLORIDE
FluoxetineFLUOXETINE HYDROCHLORIDENuCare Pharmaceuticals,Inc.b1409772-e719-67f5-e053-2995a90ab5b62024-07-17Boxed warning, Warnings, Adverse reactionsName fallback
generic name: FLUOXETINE HYDROCHLORIDE
FluoxetineFLUOXETINE HYDROCHLORIDENuCare Pharmaceuticals,Inc.a32f1a0b-a9ee-883a-e053-2a95a90a8c122024-07-17Boxed warning, Warnings, Adverse reactionsName fallback
generic name: FLUOXETINE HYDROCHLORIDE
FluoxetineFLUOXETINE HYDROCHLORIDENuCare Pharmaceuticals,Inc.a7bea6e9-cf90-a963-e053-2a95a90a10682024-07-17Boxed warning, Warnings, Adverse reactionsName fallback
generic name: FLUOXETINE HYDROCHLORIDE
FluoxetineFLUOXETINE HYDROCHLORIDENuCare Pharmaceuticals, Inc.50345702-9869-5335-e054-00144ff88e882024-07-09Boxed warning, Warnings, Adverse reactionsName fallback
generic name: FLUOXETINE HYDROCHLORIDE
Fluoxetine hydrochlorideFLUOXETINE HYDROCHLORIDENorthStar Rx LLC1f8b1834-d5d7-72b6-d2ed-cb074344d59e2024-06-13Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Fluoxetine hydrochloride
generic name: FLUOXETINE HYDROCHLORIDE
FluoxetineFLUOXETINE HYDROCHLORIDECalvin Scott & Co., Inc.4915e22f-cecb-4261-8389-9bb417a20e822024-04-18Boxed warning, Warnings, Adverse reactionsName fallback
generic name: FLUOXETINE HYDROCHLORIDE
Fluoxetine hydrochlorideFLUOXETINE HYDROCHLORIDEDr. Reddy's Laboratories Inc.80e52273-9741-6aef-eb24-8a93ead85ba72024-03-20Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Fluoxetine hydrochloride
generic name: FLUOXETINE HYDROCHLORIDE
FluoxetineFLUOXETINE HYDROCHLORIDEPAI Holdings, LLC dba PAI Pharma180a07fd-1f6a-4617-b8e0-f938c65ba2732024-03-19Boxed warning, Warnings, Adverse reactionsName fallback
generic name: FLUOXETINE HYDROCHLORIDE
FluoxetineFLUOXETINE HYDROCHLORIDEMedsource Pharmaceuticals1302fc08-d5fa-54b4-e063-6394a90a52752024-03-06Boxed warning, Warnings, Adverse reactionsName fallback
generic name: FLUOXETINE HYDROCHLORIDE
FluoxetineFLUOXETINE HYDROCHLORIDENorthStar Rx LLC97960730-432e-4e94-bb4e-62a3157270a82024-02-12Boxed warning, Warnings, Adverse reactionsName fallback
generic name: FLUOXETINE HYDROCHLORIDE
FluoxetineFLUOXETINE HYDROCHLORIDETIME CAP LABORATORIES, INC.d7a4db7f-cdac-2b36-e053-2995a90a8d642024-02-05Boxed warning, Warnings, Adverse reactionsName fallback
generic name: FLUOXETINE HYDROCHLORIDE
FluoxetineFLUOXETINE HYDROCHLORIDEA-S Medication Solutions578ca8f8-86eb-4247-a0b3-50c3837a982e2024-01-03Boxed warning, Warnings, Adverse reactionsName fallback
generic name: FLUOXETINE HYDROCHLORIDE
FluoxetineFLUOXETINE HYDROCHLORIDEA-S Medication Solutions08f3c11c-9ba0-4c53-bf31-264725e611ea2023-12-05Boxed warning, Warnings, Adverse reactionsName fallback
generic name: FLUOXETINE HYDROCHLORIDE
FluoxetineFLUOXETINE HYDROCHLORIDEBluePoint Laboratoriesf89a5800-6fdb-4938-a28e-3bf1aeb1c21a2023-11-30Boxed warning, Warnings, Adverse reactionsName fallback
generic name: FLUOXETINE HYDROCHLORIDE
FluoxetineFLUOXETINE HYDROCHLORIDEA-S Medication Solutions3fba8d68-0663-4053-93ee-7531246fd47d2023-11-17Boxed warning, Warnings, Adverse reactionsName fallback
generic name: FLUOXETINE HYDROCHLORIDE
FluoxetineFLUOXETINE HYDROCHLORIDEA-S Medication Solutionsa408c325-d2d5-4e88-85ce-96913eb581832023-10-24Boxed warning, Warnings, Adverse reactionsName fallback
generic name: FLUOXETINE HYDROCHLORIDE
FluoxetineFLUOXETINE HYDROCHLORIDEA-S Medication Solutions224c8c17-0183-4cd7-ab9e-0062f3c624f02023-10-16Boxed 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 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0615-1357fluoxetinefluoxetine hydrochlorideNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
67046-211Fluoxetine HydrochlorideFluoxetine HydrochlorideContract Pharmacy Services-PAANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
44251ORIG2005-08-01
30814ORIG2004-06-04