Application 090083

Type
ANDA
Sponsor
AUROBINDO PHARMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LOSARTAN POTASSIUMLOSARTAN POTASSIUMTABLET;ORAL25MGNoNo
002LOSARTAN POTASSIUMLOSARTAN POTASSIUMTABLET;ORAL50MGNoNo
003LOSARTAN POTASSIUMLOSARTAN POTASSIUMTABLET;ORAL100MGNoNo

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
A090083-001LOSARTAN POTASSIUMLOSARTAN POTASSIUM25MGTABLET / ORALAB2010-10-06
A090083-002LOSARTAN POTASSIUMLOSARTAN POTASSIUM50MGTABLET / ORALAB2010-10-06
A090083-003LOSARTAN POTASSIUMLOSARTAN POTASSIUM100MGTABLET / ORALAB2010-10-06

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A090083-001AB
A090083-002AB
A090083-003AB

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 22:38:342026-08A090083-001LOSARTAN POTASSIUM25MGTABLET / ORALAB2010-10-0684e616aacf4f…
2026-09-14 22:38:342026-08A090083-002LOSARTAN POTASSIUM50MGTABLET / ORALAB2010-10-0684e616aacf4f…
2026-09-14 22:38:342026-08A090083-003LOSARTAN POTASSIUM100MGTABLET / ORALAB2010-10-0684e616aacf4f…
2026-08-18 06:07:402026-07A090083-001LOSARTAN POTASSIUM25MGTABLET / ORALAB2010-10-06caaa826d4ba7…
2026-08-18 06:07:402026-07A090083-002LOSARTAN POTASSIUM50MGTABLET / ORALAB2010-10-06caaa826d4ba7…
2026-08-18 06:07:402026-07A090083-003LOSARTAN POTASSIUM100MGTABLET / ORALAB2010-10-06caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A090083-001LOSARTAN POTASSIUM25MGTABLET / ORALAB2010-10-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090083-002LOSARTAN POTASSIUM50MGTABLET / ORALAB2010-10-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090083-003LOSARTAN POTASSIUM100MGTABLET / ORALAB2010-10-06011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090083-001LOSARTAN POTASSIUM25MGTABLET / ORALAB2010-10-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090083-002LOSARTAN POTASSIUM50MGTABLET / ORALAB2010-10-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090083-003LOSARTAN POTASSIUM100MGTABLET / ORALAB2010-10-0631067a03dcf5…
2025-08-23 18:47 UTC2025-08A090083-001LOSARTAN POTASSIUM25MGTABLET / ORALAB2010-10-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090083-002LOSARTAN POTASSIUM50MGTABLET / ORALAB2010-10-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090083-003LOSARTAN POTASSIUM100MGTABLET / ORALAB2010-10-066a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090083-001LOSARTAN POTASSIUM25MGTABLET / ORALAB2010-10-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090083-002LOSARTAN POTASSIUM50MGTABLET / ORALAB2010-10-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090083-003LOSARTAN POTASSIUM100MGTABLET / ORALAB2010-10-06fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090083-001LOSARTAN POTASSIUM25MGTABLET / ORALAB2010-10-06b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090083-002LOSARTAN POTASSIUM50MGTABLET / ORALAB2010-10-06b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090083-003LOSARTAN POTASSIUM100MGTABLET / ORALAB2010-10-06b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090083-001LOSARTAN POTASSIUM25MGTABLET / ORALAB2010-10-0603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090083-002LOSARTAN POTASSIUM50MGTABLET / ORALAB2010-10-0603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090083-003LOSARTAN POTASSIUM100MGTABLET / ORALAB2010-10-0603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090083-001LOSARTAN POTASSIUM25MGTABLET / ORALAB2010-10-062680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090083-002LOSARTAN POTASSIUM50MGTABLET / ORALAB2010-10-062680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090083-003LOSARTAN POTASSIUM100MGTABLET / ORALAB2010-10-062680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090083-001LOSARTAN POTASSIUM25MGTABLET / ORALAB2010-10-065bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090083-002LOSARTAN POTASSIUM50MGTABLET / ORALAB2010-10-065bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090083-003LOSARTAN POTASSIUM100MGTABLET / ORALAB2010-10-065bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090083-001LOSARTAN POTASSIUM25MGTABLET / ORALAB2010-10-06d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090083-002LOSARTAN POTASSIUM50MGTABLET / ORALAB2010-10-06d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090083-003LOSARTAN POTASSIUM100MGTABLET / ORALAB2010-10-06d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090083-001LOSARTAN POTASSIUM25MGTABLET / ORALAB2010-10-06d06236e962d9…
2024-10-29 15:01 UTC2024-10A090083-002LOSARTAN POTASSIUM50MGTABLET / ORALAB2010-10-06d06236e962d9…
2024-10-29 15:01 UTC2024-10A090083-003LOSARTAN POTASSIUM100MGTABLET / ORALAB2010-10-06d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090083-001LOSARTAN POTASSIUM25MGTABLET / ORALAB2010-10-0679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090083-002LOSARTAN POTASSIUM50MGTABLET / ORALAB2010-10-0679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090083-003LOSARTAN POTASSIUM100MGTABLET / ORALAB2010-10-0679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090083-001LOSARTAN POTASSIUM25MGTABLET / ORALAB2010-10-06301d65b070ca…

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 22:38:342026-08A090083-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A090083-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A090083-003AB184e616aacf4f…
2026-08-18 06:07:402026-07A090083-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A090083-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A090083-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A090083-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090083-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090083-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090083-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090083-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090083-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A090083-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090083-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090083-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090083-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090083-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090083-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090083-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090083-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090083-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090083-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090083-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090083-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090083-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090083-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090083-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090083-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090083-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090083-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090083-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090083-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090083-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090083-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A090083-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A090083-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090083-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090083-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090083-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090083-001AB1301d65b070ca…

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 1 of 2 · 23 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Losartan PotassiumLOSARTAN POTASSIUMREMEDYREPACK INC.df4f55f0-fb11-4f6f-a7ed-127b50f955fc2026-07-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090083
application number: ANDA090083
ndc (product): 70518-2316
Losartan PotassiumLOSARTAN POTASSIUMREMEDYREPACK INC.f7cf8a7d-90f1-46a3-abff-1eb316aa7d722026-07-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090083
application number: ANDA090083
ndc (product): 70518-2132
Losartan PotassiumLOSARTAN POTASSIUMREMEDYREPACK INC.25c93638-7016-47d2-a57c-e4a5245ca41b2026-06-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090083
application number: ANDA090083
Losartan PotassiumLOSARTAN POTASSIUMUnit Dose Solutions, Inc.552a2f78-6318-310f-e063-6394a90abb152026-06-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090083
application number: ANDA090083
Losartan PotassiumLOSARTAN POTASSIUMREMEDYREPACK INC.41069514-0491-41fe-b7fe-a52d42d338482026-06-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090083
application number: ANDA090083
Losartan PotassiumLOSARTAN POTASSIUMPD-Rx Pharmaceuticals, Inc.f9a92771-5c73-4f17-ac38-29fabfd4a9192026-05-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090083
application number: ANDA090083
Losartan PotassiumLOSARTAN POTASSIUMPD-Rx Pharmaceuticals, Inc.5f7612dc-dccf-49e2-b541-3dab9dc1f97a2026-05-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090083
application number: ANDA090083
Losartan PotassiumLOSARTAN POTASSIUMNorthwind Health Company, LLCd9ced981-d791-6600-e053-2995a90ace3b2026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090083
application number: ANDA090083
Losartan PotassiumLOSARTAN POTASSIUMNorthwind Health Company, LLCd9de3627-9aa2-65c8-e053-2995a90ab5ec2026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090083
application number: ANDA090083
Losartan PotassiumLOSARTAN POTASSIUMNorthwind Health Company, LLCd9dfae69-9ce7-0c6b-e053-2a95a90aace82026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090083
application number: ANDA090083
Losartan PotassiumLOSARTAN POTASSIUMQPharma, Inc.2a7513c4-b73b-46fe-ba86-6e58658cdbc72025-12-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090083
application number: ANDA090083
Losartan PotassiumLOSARTAN POTASSIUMQPharma, Inc.16a6a582-eb4d-41bc-9d49-fc1d4117b29a2025-12-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090083
application number: ANDA090083
Losartan PotassiumLOSARTAN POTASSIUMAurobindo Pharma Limited31366b4b-dfd6-4fda-babe-2cb3d2c14a2b2025-09-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090083
application number: ANDA090083
Losartan PotassiumLOSARTAN POTASSIUMBryant Ranch Prepack4d7a0e82-4791-4e3f-932a-2f1a2993ba362025-09-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090083
application number: ANDA090083
ndc (product): 71335-1235
Losartan PotassiumLOSARTAN POTASSIUMBryant Ranch Prepack45d0b1cc-d88d-4044-9692-c143cdf7a1b82025-09-18Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090083
application number: ANDA090083
ndc (product): 71335-1174
Losartan PotassiumLOSARTAN POTASSIUMBryant Ranch Prepack0c728db3-86ae-4ed9-b86a-78ff8d18876a2025-09-18Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090083
application number: ANDA090083
ndc (product): 71335-1221
Losartan PotassiumLOSARTAN POTASSIUMA-S Medication Solutions73bb1210-fa46-4c88-b07c-14ff5580ef182025-08-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090083
application number: ANDA090083
Losartan PotassiumLOSARTAN POTASSIUMNuCare Pharmaceuticals,Inc.9130921b-02f0-82d6-e053-2995a90a9c0a2024-06-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090083
application number: ANDA090083
Losartan PotassiumLOSARTAN POTASSIUMNuCare Pharmaceuticals,Inc.91305ca4-7d56-2052-e053-2995a90a5d612024-06-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090083
application number: ANDA090083
Losartan PotassiumLOSARTAN POTASSIUMNuCare Pharmaceuticals,Inc.8c2b3412-254b-8fa9-e053-2a95a90a7dc62024-06-18Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090083
application number: ANDA090083

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 3 of 3 · 201 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
70518-2132Losartan PotassiumLosartan PotassiumREMEDYREPACK INC.ANDACurrent
70518-2132Losartan PotassiumLosartan PotassiumREMEDYREPACK INC.ANDACurrent
70518-2132Losartan PotassiumLosartan PotassiumREMEDYREPACK INC.ANDACurrent
70518-2316Losartan PotassiumLosartan PotassiumREMEDYREPACK INC.ANDACurrent
70934-204Losartan PotassiumLosartan PotassiumDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-239Losartan PotassiumLosartan PotassiumDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-239Losartan PotassiumLosartan PotassiumDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-939Losartan PotassiumLosartan PotassiumDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
71205-194Losartan PotassiumLosartan PotassiumProficient Rx LPANDACurrent
71205-194Losartan PotassiumLosartan PotassiumProficient Rx LPANDACurrent
71205-212Losartan PotassiumLosartan PotassiumProficient Rx LPANDACurrent
71205-281Losartan PotassiumLosartan PotassiumProficient Rx LPANDACurrent
71205-281Losartan PotassiumLosartan PotassiumProficient Rx LPANDACurrent
71205-281Losartan PotassiumLosartan PotassiumProficient Rx LPANDACurrent
71335-0698Losartan PotassiumLosartan PotassiumBryant Ranch PrepackANDACurrent
71335-0698Losartan PotassiumLosartan PotassiumBryant Ranch PrepackANDACurrent
71335-0698Losartan PotassiumLosartan PotassiumBryant Ranch PrepackANDACurrent
71335-0698Losartan PotassiumLosartan PotassiumBryant Ranch PrepackANDACurrent
71335-0700Losartan PotassiumLosartan PotassiumBryant Ranch PrepackANDACurrent
71335-0700Losartan PotassiumLosartan PotassiumBryant Ranch PrepackANDACurrent
71335-0972Losartan PotassiumLosartan PotassiumBryant Ranch PrepackANDACurrent
71335-0972Losartan PotassiumLosartan PotassiumBryant Ranch PrepackANDACurrent
71335-0972Losartan PotassiumLosartan PotassiumBryant Ranch PrepackANDACurrent
71335-0972Losartan PotassiumLosartan PotassiumBryant Ranch PrepackANDACurrent
71335-1174Losartan PotassiumLosartan PotassiumBryant Ranch PrepackANDACurrent
71335-1174Losartan PotassiumLosartan PotassiumBryant Ranch PrepackANDACurrent
71335-1174Losartan PotassiumLosartan PotassiumBryant Ranch PrepackANDACurrent
71335-1221Losartan PotassiumLosartan PotassiumBryant Ranch PrepackANDACurrent
71335-1221Losartan PotassiumLosartan PotassiumBryant Ranch PrepackANDACurrent
71335-1221Losartan PotassiumLosartan PotassiumBryant Ranch PrepackANDACurrent
71335-1235Losartan PotassiumLosartan PotassiumBryant Ranch PrepackANDACurrent
71335-1235Losartan PotassiumLosartan PotassiumBryant Ranch PrepackANDACurrent
71335-1235Losartan PotassiumLosartan PotassiumBryant Ranch PrepackANDACurrent
71610-082Losartan PotassiumLosartan PotassiumAphena Pharma Solutions - Tennessee, LLCANDACurrent
71610-083Losartan PotassiumLosartan PotassiumAphena Pharma Solutions - Tennessee, LLCANDACurrent
71610-171Losartan PotassiumLosartan PotassiumAphena Pharma Solutions - Tennessee, LLCANDACurrent
71610-241Losartan PotassiumLosartan PotassiumAphena Pharma Solutions - Tennessee, LLCANDACurrent
71610-282LOSARTAN POTASSIUMLOSARTAN POTASSIUMAphena Pharma Solutions - Tennessee, LLCANDACurrent
71610-370LOSARTAN POTASSIUMLOSARTAN POTASSIUMAphena Pharma Solutions - Tennessee, LLCANDACurrent
71610-370LOSARTAN POTASSIUMLOSARTAN POTASSIUMAphena Pharma Solutions - Tennessee, LLCANDACurrent
71610-415LOSARTAN POTASSIUMLOSARTAN POTASSIUMAphena Pharma Solutions - Tennessee, LLCANDACurrent