Application 076001

Type
ANDA
Sponsor
TEVA PHARMS USA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001FLUOXETINE HYDROCHLORIDEFLUOXETINE HYDROCHLORIDECAPSULE;ORALEQ 10MG BASENoNo
002FLUOXETINE HYDROCHLORIDEFLUOXETINE HYDROCHLORIDECAPSULE;ORALEQ 20MG BASENoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A076001-001FLUOXETINE HYDROCHLORIDEFLUOXETINE HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB12002-01-29
A076001-002FLUOXETINE HYDROCHLORIDEFLUOXETINE HYDROCHLORIDEEQ 20MG BASECAPSULE / ORALAB12002-01-29

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A076001-001AB1
A076001-002AB1

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 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A076001-001FLUOXETINE HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB12002-01-29caaa826d4ba7…
2026-08-18 06:07:402026-07A076001-002FLUOXETINE HYDROCHLORIDEEQ 20MG BASECAPSULE / ORALAB12002-01-29caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A076001-001FLUOXETINE HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB12002-01-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076001-002FLUOXETINE HYDROCHLORIDEEQ 20MG BASECAPSULE / ORALAB12002-01-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076001-001FLUOXETINE HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB12002-01-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076001-002FLUOXETINE HYDROCHLORIDEEQ 20MG BASECAPSULE / ORALAB12002-01-2931067a03dcf5…
2025-08-23 18:47 UTC2025-08A076001-001FLUOXETINE HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB12002-01-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076001-002FLUOXETINE HYDROCHLORIDEEQ 20MG BASECAPSULE / ORALAB12002-01-296a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076001-001FLUOXETINE HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB12002-01-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076001-002FLUOXETINE HYDROCHLORIDEEQ 20MG BASECAPSULE / ORALAB12002-01-29fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076001-001FLUOXETINE HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB12002-01-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076001-002FLUOXETINE HYDROCHLORIDEEQ 20MG BASECAPSULE / ORALAB12002-01-29b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076001-001FLUOXETINE HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB12002-01-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076001-002FLUOXETINE HYDROCHLORIDEEQ 20MG BASECAPSULE / ORALAB12002-01-2903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076001-001FLUOXETINE HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB12002-01-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076001-002FLUOXETINE HYDROCHLORIDEEQ 20MG BASECAPSULE / ORALAB12002-01-292680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076001-001FLUOXETINE HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB12002-01-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076001-002FLUOXETINE HYDROCHLORIDEEQ 20MG BASECAPSULE / ORALAB12002-01-295bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076001-001FLUOXETINE HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB12002-01-29d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076001-002FLUOXETINE HYDROCHLORIDEEQ 20MG BASECAPSULE / ORALAB12002-01-29d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076001-001FLUOXETINE HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB12002-01-29d06236e962d9…
2024-10-29 15:01 UTC2024-10A076001-002FLUOXETINE HYDROCHLORIDEEQ 20MG BASECAPSULE / ORALAB12002-01-29d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076001-001FLUOXETINE HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB12002-01-2979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076001-002FLUOXETINE HYDROCHLORIDEEQ 20MG BASECAPSULE / ORALAB12002-01-2979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076001-001FLUOXETINE HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB12002-01-29301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076001-002FLUOXETINE HYDROCHLORIDEEQ 20MG BASECAPSULE / ORALAB12002-01-29301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076001-001FLUOXETINE HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB12002-01-291e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076001-002FLUOXETINE HYDROCHLORIDEEQ 20MG BASECAPSULE / ORALAB12002-01-291e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076001-001FLUOXETINE HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB12002-01-298072bd15b7f6…
2024-05-31 18:47 UTC2024-05A076001-002FLUOXETINE HYDROCHLORIDEEQ 20MG BASECAPSULE / ORALAB12002-01-298072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076001-001FLUOXETINE HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB12002-01-295c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076001-002FLUOXETINE HYDROCHLORIDEEQ 20MG BASECAPSULE / ORALAB12002-01-295c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A076001-001FLUOXETINE HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB12002-01-295d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A076001-002FLUOXETINE HYDROCHLORIDEEQ 20MG BASECAPSULE / ORALAB12002-01-295d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A076001-001FLUOXETINE HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB12002-01-294b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A076001-002FLUOXETINE HYDROCHLORIDEEQ 20MG BASECAPSULE / ORALAB12002-01-294b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A076001-001FLUOXETINE HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB12002-01-2974a2ff9319b5…
2019-12-13 00:20 UTC2019-12A076001-002FLUOXETINE HYDROCHLORIDEEQ 20MG BASECAPSULE / ORALAB12002-01-2974a2ff9319b5…
2022-03-09 01:35 UTC2022-03A076001-001FLUOXETINE HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB12002-01-29bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A076001-002FLUOXETINE HYDROCHLORIDEEQ 20MG BASECAPSULE / ORALAB12002-01-29bb7c543d1eb4…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A076001-001AB11caaa826d4ba7…
2026-08-18 06:07:402026-07A076001-002AB11caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A076001-001AB11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076001-002AB11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076001-001AB1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076001-002AB1131067a03dcf5…
2025-08-23 18:47 UTC2025-08A076001-001AB116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076001-002AB116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076001-001AB11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076001-002AB11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076001-001AB11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076001-002AB11b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076001-001AB1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076001-002AB1103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076001-001AB112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076001-002AB112680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076001-001AB115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076001-002AB115bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076001-001AB11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076001-002AB11d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076001-001AB11d06236e962d9…
2024-10-29 15:01 UTC2024-10A076001-002AB11d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076001-001AB1179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076001-002AB1179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076001-001AB11301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076001-002AB11301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076001-001AB111e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076001-002AB111e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076001-001AB118072bd15b7f6…
2024-05-31 18:47 UTC2024-05A076001-002AB118072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076001-001AB115c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076001-002AB115c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A076001-001AB115d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A076001-002AB115d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A076001-001AB114b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A076001-002AB114b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A076001-001AB1174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A076001-002AB1174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A076001-001AB11bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A076001-002AB11bb7c543d1eb4…

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 1 · 13 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FluoxetineFLUOXETINEREMEDYREPACK INC.24926986-7552-4f1a-8366-f035bbd071042026-07-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076001
application number: ANDA076001
ndc (product): 70518-1619
FluoxetineFLUOXETINEProficient Rx LP1a2a5194-b793-4c62-a177-040dad38526b2026-05-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076001
application number: ANDA076001
FluoxetineFLUOXETINEREMEDYREPACK INC.a1b40d46-5233-49d7-9833-762cb69990122026-04-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076001
application number: ANDA076001
FluoxetineFLUOXETINENorthwind Health Company, LLC4dee4a1a-360c-532e-e063-6394a90a84262026-04-07Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076001
application number: ANDA076001
FluoxetineFLUOXETINELegacy Pharmaceutical Packaging, LLCb07f9eab-44ac-4667-bd46-52d736daa5d62026-03-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076001
application number: ANDA076001
ndc (product): 68645-131
ndc (product): 68645-130
FluoxetineFLUOXETINEQPharma Incb4831735-6731-473a-b4f0-1f4a67aa71202025-12-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076001
application number: ANDA076001
FluoxetineFLUOXETINENCS HealthCare of KY, LLC dba Vangard Labs647e17f5-a15a-4e77-922c-24a5db2118bc2025-07-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076001
application number: ANDA076001
FluoxetineFLUOXETINEProficient Rx LPcece294b-c414-4832-a8a2-22fb66aabda92024-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076001
application number: ANDA076001
ndc (product): 71205-178
FluoxetineFLUOXETINENuCare Pharmaceuticals,Inc.5631bb72-798a-6efc-e054-00144ff8d46c2024-07-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076001
application number: ANDA076001
ndc (product): 68071-4033
FluoxetineFLUOXETINENuCare Pharmaceuticals,Inc.78994632-74b3-951c-e053-2a91aa0ac1c82024-06-12Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076001
application number: ANDA076001
ndc (product): 68071-4606
FluoxetineFLUOXETINEBryant Ranch Prepack7553d708-22a0-44ea-b907-7a86f2657f4c2024-05-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076001
application number: ANDA076001
ndc (product): 71335-1048
FluoxetineFLUOXETINEBryant Ranch Prepack493a5946-e750-4500-afd1-8f3fdc1d420e2024-04-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076001
application number: ANDA076001
ndc (product): 71335-0924
FluoxetineFLUOXETINETeva Pharmaceuticals USA, Inc.06d71a33-5578-4012-b11d-764f45bc1e6a2023-08-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076001
application number: ANDA076001

NDC Listings For This Application#

NDC listings for this application page 2 of 2 · 128 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
66116-464FluoxetineFluoxetineMedVantx, Inc.ANDACurrent
66116-467FluoxetineFluoxetineMedVantx, Inc.ANDACurrent
67046-212FluoxetineFluoxetineContract Pharmacy Services-PAANDACurrent
68071-4033FluoxetineFluoxetineNuCare Pharmaceuticals,InANDACurrent
68071-4033FluoxetineFluoxetineNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4033FluoxetineFluoxetineNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4606FluoxetineFluoxetineNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4606FluoxetineFluoxetineNuCare Pharmaceuticals,Inc.ANDACurrent
68645-130FluoxetineFluoxetineLegacy Pharmaceutical Packaging, LLCANDACurrent
68645-130FluoxetineFluoxetineLegacy Pharmaceutical Packaging, LLCANDACurrent
68645-130FluoxetineFluoxetineLegacy Pharmaceutical Packaging, LLCANDACurrent
68645-130FluoxetineFluoxetineLegacy Pharmaceutical Packaging, LLCANDACurrent
68645-130FluoxetineFluoxetineLegacy Pharmaceutical Packaging, LLCANDACurrent
68645-130FluoxetineFluoxetineLegacy Pharmaceutical Packaging, LLCANDACurrent
68645-131FluoxetineFluoxetineLegacy Pharmaceutical Packaging, LLCANDACurrent
68645-131FluoxetineFluoxetineLegacy Pharmaceutical Packaging, LLCANDACurrent
68645-131FluoxetineFluoxetineLegacy Pharmaceutical Packaging, LLCANDACurrent
68645-131FluoxetineFluoxetineLegacy Pharmaceutical Packaging, LLCANDACurrent
68645-131FluoxetineFluoxetineLegacy Pharmaceutical Packaging, LLCANDACurrent
68645-131FluoxetineFluoxetineLegacy Pharmaceutical Packaging, LLCANDACurrent
70518-1432FluoxetineFluoxetineREMEDYREPACK INC.ANDACurrent
70518-1432FluoxetineFluoxetineREMEDYREPACK INC.ANDACurrent
70518-1619FluoxetineFluoxetineREMEDYREPACK INC.ANDACurrent
70518-1619FluoxetineFluoxetineREMEDYREPACK INC.ANDACurrent
70934-359FluoxetineFluoxetineDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-359FluoxetineFluoxetineDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-359FluoxetineFluoxetineDenton Pharma, Inc. dba Northwind PharmaceuticalsANDACurrent
70934-490FluoxetineFluoxetineDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-712FluoxetineFluoxetineDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
71205-178FluoxetineFluoxetineProficient Rx LPANDACurrent
71205-178FluoxetineFluoxetineProficient Rx LPANDACurrent
71205-178FluoxetineFluoxetineProficient Rx LPANDACurrent
71205-178FluoxetineFluoxetineProficient Rx LPANDACurrent
71335-0924FluoxetineFluoxetineBryant Ranch PrepackANDACurrent
71335-0924FluoxetineFluoxetineBryant Ranch PrepackANDACurrent
71335-0924FluoxetineFluoxetineBryant Ranch PrepackANDACurrent
71335-0924FluoxetineFluoxetineBryant Ranch PrepackANDACurrent
71335-1048FluoxetineFluoxetineBryant Ranch PrepackANDACurrent
71335-1048FluoxetineFluoxetineBryant Ranch PrepackANDACurrent
71335-1048FluoxetineFluoxetineBryant Ranch PrepackANDACurrent
71335-1048FluoxetineFluoxetineBryant Ranch PrepackANDACurrent
71610-024FluoxetineFluoxetineAphena Pharma Solutions - Tennessee, LLCANDACurrent
71610-024FluoxetineFluoxetineAphena Pharma Solutions - Tennessee, LLCANDACurrent
71610-028FluoxetineFluoxetineAphena Pharma Solutions - Tennessee, LLCANDACurrent
71610-028FluoxetineFluoxetineAphena Pharma Solutions - Tennessee, LLCANDACurrent
71610-464FluoxetineFluoxetineAphena Pharma Solutions - Tennessee, LLCANDACurrent
71610-464FluoxetineFluoxetineAphena Pharma Solutions - Tennessee, LLCANDACurrent
75921-648FluoxetineFluoxetineLife Line Home Care Services, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
23790ORIG2005-08-01