Application 078243

Type
ANDA
Sponsor
ZYDUS PHARMS USA INC

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
A078243-001LOSARTAN POTASSIUMLOSARTAN POTASSIUM25MGTABLET / ORALAB2010-10-06
A078243-002LOSARTAN POTASSIUMLOSARTAN POTASSIUM50MGTABLET / ORALAB2010-10-06
A078243-003LOSARTAN 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
A078243-001AB
A078243-002AB
A078243-003AB

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 22:38:342026-08A078243-001LOSARTAN POTASSIUM25MGTABLET / ORALAB2010-10-0684e616aacf4f…
2026-09-14 22:38:342026-08A078243-002LOSARTAN POTASSIUM50MGTABLET / ORALAB2010-10-0684e616aacf4f…
2026-09-14 22:38:342026-08A078243-003LOSARTAN POTASSIUM100MGTABLET / ORALAB2010-10-0684e616aacf4f…
2026-08-18 06:07:402026-07A078243-001LOSARTAN POTASSIUM25MGTABLET / ORALAB2010-10-06caaa826d4ba7…
2026-08-18 06:07:402026-07A078243-002LOSARTAN POTASSIUM50MGTABLET / ORALAB2010-10-06caaa826d4ba7…
2026-08-18 06:07:402026-07A078243-003LOSARTAN POTASSIUM100MGTABLET / ORALAB2010-10-06caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078243-001LOSARTAN POTASSIUM25MGTABLET / ORALAB2010-10-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078243-002LOSARTAN POTASSIUM50MGTABLET / ORALAB2010-10-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078243-003LOSARTAN POTASSIUM100MGTABLET / ORALAB2010-10-06011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078243-001LOSARTAN POTASSIUM25MGTABLET / ORALAB2010-10-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078243-002LOSARTAN POTASSIUM50MGTABLET / ORALAB2010-10-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078243-003LOSARTAN POTASSIUM100MGTABLET / ORALAB2010-10-0631067a03dcf5…
2025-08-23 18:47 UTC2025-08A078243-001LOSARTAN POTASSIUM25MGTABLET / ORALAB2010-10-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078243-002LOSARTAN POTASSIUM50MGTABLET / ORALAB2010-10-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078243-003LOSARTAN POTASSIUM100MGTABLET / ORALAB2010-10-066a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078243-001LOSARTAN POTASSIUM25MGTABLET / ORALAB2010-10-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078243-002LOSARTAN POTASSIUM50MGTABLET / ORALAB2010-10-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078243-003LOSARTAN POTASSIUM100MGTABLET / ORALAB2010-10-06fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078243-001LOSARTAN POTASSIUM25MGTABLET / ORALAB2010-10-06b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078243-002LOSARTAN POTASSIUM50MGTABLET / ORALAB2010-10-06b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078243-003LOSARTAN POTASSIUM100MGTABLET / ORALAB2010-10-06b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078243-001LOSARTAN POTASSIUM25MGTABLET / ORALAB2010-10-0603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078243-002LOSARTAN POTASSIUM50MGTABLET / ORALAB2010-10-0603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078243-003LOSARTAN POTASSIUM100MGTABLET / ORALAB2010-10-0603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078243-001LOSARTAN POTASSIUM25MGTABLET / ORALAB2010-10-062680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078243-002LOSARTAN POTASSIUM50MGTABLET / ORALAB2010-10-062680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078243-003LOSARTAN POTASSIUM100MGTABLET / ORALAB2010-10-062680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078243-001LOSARTAN POTASSIUM25MGTABLET / ORALAB2010-10-065bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078243-002LOSARTAN POTASSIUM50MGTABLET / ORALAB2010-10-065bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078243-003LOSARTAN POTASSIUM100MGTABLET / ORALAB2010-10-065bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078243-001LOSARTAN POTASSIUM25MGTABLET / ORALAB2010-10-06d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078243-002LOSARTAN POTASSIUM50MGTABLET / ORALAB2010-10-06d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078243-003LOSARTAN POTASSIUM100MGTABLET / ORALAB2010-10-06d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078243-001LOSARTAN POTASSIUM25MGTABLET / ORALAB2010-10-06d06236e962d9…
2024-10-29 15:01 UTC2024-10A078243-002LOSARTAN POTASSIUM50MGTABLET / ORALAB2010-10-06d06236e962d9…
2024-10-29 15:01 UTC2024-10A078243-003LOSARTAN POTASSIUM100MGTABLET / ORALAB2010-10-06d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078243-001LOSARTAN POTASSIUM25MGTABLET / ORALAB2010-10-0679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078243-002LOSARTAN POTASSIUM50MGTABLET / ORALAB2010-10-0679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078243-003LOSARTAN POTASSIUM100MGTABLET / ORALAB2010-10-0679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078243-001LOSARTAN 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 22:38:342026-08A078243-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A078243-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A078243-003AB184e616aacf4f…
2026-08-18 06:07:402026-07A078243-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A078243-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A078243-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078243-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078243-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078243-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078243-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078243-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078243-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A078243-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078243-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078243-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078243-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078243-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078243-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078243-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078243-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078243-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078243-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078243-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078243-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078243-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078243-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078243-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078243-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078243-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078243-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078243-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078243-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078243-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078243-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A078243-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A078243-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078243-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078243-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078243-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078243-001AB1301d65b070ca…

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 1 · 12 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Losartan PotassiumLOSARTAN POTASSIUMCardinal Health 107, LLC021cd76a-b093-4704-8410-5e7d01e20a542026-08-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078243
application number: ANDA078243
Losartan PotassiumLOSARTAN POTASSIUMMajor Pharmaceuticalsc15387df-87a4-4784-acb5-7dd550498f8f2026-07-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078243
application number: ANDA078243
Losartan PotassiumLOSARTAN POTASSIUMZydus Pharmaceuticals USA Inc.3233c707-70b6-4c29-8210-913eeb2a38ed2026-07-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078243
application number: ANDA078243
ndc (product): 68382-137
ndc (product): 68382-135
ndc (product): 68382-136
Losartan PotassiumLOSARTAN POTASSIUMAmerican Health Packaginge7f6b25b-ec4c-4c3a-a541-617d2d9ab3932026-06-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078243
application number: ANDA078243
ndc (product): 68084-348
ndc (product): 68084-347
ndc (product): 68084-346
Losartan PotassiumLOSARTAN POTASSIUMCardinal Health 107, LLCb83d896a-c7e9-4508-814c-425b88a87b162026-06-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078243
application number: ANDA078243
Losortan PotassiumLOSARTAN POTASSIUMPreferred Pharmaceuticals Inc.25651749-8950-43ff-bcbd-3bb85f57a3602026-05-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078243
application number: ANDA078243
Losortan PotassiumLOSARTAN POTASSIUMBryant Ranch Prepack1b285c10-f468-4d87-b36d-79047f686c582026-05-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078243
application number: ANDA078243
ndc (product): 71335-1644
Losartan PotassiumLOSARTAN POTASSIUMZydus Lifesciences Limited9ccd6823-e813-472c-99cd-c6ef25e74bed2026-01-12Exact identifier
application applno (ANDA): 078243
application number: ANDA078243
ndc (product): 65841-731
ndc (product): 65841-730
ndc (product): 65841-729
Losartan PotassiumLOSARTAN POTASSIUMQuallent Pharmaceuticals Health LLC1a9e1ffd-edf1-4e35-a7f5-ca351c507d7f2026-01-12Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078243
application number: ANDA078243
ndc (product): 82009-042
ndc (product): 82009-044
ndc (product): 82009-043
Losortan PotassiumLOSARTAN POTASSIUMAvPAKa6cd0b5f-2bd6-bed9-e053-2995a90a31912026-01-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078243
application number: ANDA078243
LOSARTAN POTASSIUMLOSARTAN POTASSIUMDIRECT RXa58c56b2-e05c-6697-e053-2a95a90ad4662025-01-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078243
application number: ANDA078243
ndc (product): 72189-082
Losortan PotassiumLOSARTAN POTASSIUMProficient Rx LP364fe10e-11ca-4ee6-9f67-c85dec09aca52019-11-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078243
application number: ANDA078243

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 2 of 2 · 143 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
63739-686Losortan PotassiumLosartan PotassiumMcKesson CorporationANDACurrent
63739-686Losartan PotassiumLosartan PotassiumMckesson Corporation DBA SKY PackaginngANDACurrent
63739-686Losartan PotassiumLosartan PotassiumMckesson Corporation DBA SKY PackaginngANDACurrent
63739-698Losartan PotassiumLosartan PotassiumMcKesson Corporation dba SKY PackagingANDACurrent
63739-698Losartan PotassiumLosartan PotassiumMcKesson Corporation dba SKY PackagingANDACurrent
63739-698Losartan PotassiumLosartan PotassiumMcKesson Corporation dba SKY PackagingANDACurrent
63739-698Losartan PotassiumLosartan PotassiumMcKesson Corporation dba SKY PackagingANDACurrent
63739-698Losartan PotassiumLosartan PotassiumMcKesson CorporationANDACurrent
65841-729Losartan PotassiumLosartan PotassiumCadila Healthcare LimitedANDACurrent
65841-729Losartan PotassiumLosartan PotassiumCadila Healthcare LimitedANDACurrent
65841-729Losartan PotassiumLosartan PotassiumCadila Healthcare LimitedANDACurrent
65841-729Losartan PotassiumLosartan PotassiumZydus Lifesciences LimitedANDACurrent
65841-730Losartan PotassiumLosartan PotassiumCadila Healthcare LimitedANDACurrent
65841-730Losartan PotassiumLosartan PotassiumCadila Healthcare LimitedANDACurrent
65841-730Losartan PotassiumLosartan PotassiumCadila Healthcare LimitedANDACurrent
65841-730Losartan PotassiumLosartan PotassiumZydus Lifesciences LimitedANDACurrent
65841-731Losartan PotassiumLosartan PotassiumCadila Healthcare LimitedANDACurrent
65841-731Losartan PotassiumLosartan PotassiumCadila Healthcare LimitedANDACurrent
65841-731Losartan PotassiumLosartan PotassiumCadila Healthcare LimitedANDACurrent
65841-731Losartan PotassiumLosartan PotassiumZydus Lifesciences LimitedANDACurrent
68071-3182Losortan PotassiumLosartan PotassiumNuCare Pharmaceuticals, Inc.ANDACurrent
68071-3209Losortan PotassiumLosartan PotassiumNuCare Pharmaceuticals, Inc.ANDACurrent
68084-346Losartan PotassiumLosartan PotassiumAmerican Health PackagingANDACurrent
68084-346Losartan PotassiumLosartan PotassiumAmerican Health PackagingANDACurrent
68084-346Losartan PotassiumLosartan PotassiumAmerican Health PackagingANDACurrent
68084-347Losartan PotassiumLosartan PotassiumAmerican Health PackagingANDACurrent
68084-347Losartan PotassiumLosartan PotassiumAmerican Health PackagingANDACurrent
68084-347Losartan PotassiumLosartan PotassiumAmerican Health PackagingANDACurrent
68084-348Losartan PotassiumLosartan PotassiumAmerican Health PackagingANDACurrent
68084-348Losartan PotassiumLosartan PotassiumAmerican Health PackagingANDACurrent
68084-348Losartan PotassiumLosartan PotassiumAmerican Health PackagingANDACurrent
68382-135Losortan PotassiumLosartan PotassiumZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-135Losortan PotassiumLosartan PotassiumZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-135Losortan PotassiumLosartan PotassiumZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-136Losortan PotassiumLosartan PotassiumZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-136Losortan PotassiumLosartan PotassiumZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-136Losortan PotassiumLosartan PotassiumZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-137Losortan PotassiumLosartan PotassiumZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-137Losortan PotassiumLosartan PotassiumZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-137Losortan PotassiumLosartan PotassiumZydus Pharmaceuticals (USA) Inc.ANDACurrent
68645-586Losortan PotassiumLosartan PotassiumLegacy Pharmaceutical Packaging, LLCANDACurrent
68645-586Losortan PotassiumLosartan PotassiumLegacy Pharmaceutical Packaging, LLCANDACurrent
68645-586Losortan PotassiumLosartan PotassiumLegacy Pharmaceutical Packaging, LLCANDACurrent
68788-6445Losortan PotassiumLosartan PotassiumPreferred Pharmaceuticals IncANDACurrent
68788-7736Losortan PotassiumLosartan PotassiumPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7736Losortan PotassiumLosartan PotassiumPreferred Pharmaceuticals, Inc.ANDACurrent
70518-0557Losortan PotassiumLosartan PotassiumREMEDYREPACK INC.ANDACurrent
70518-0557Losortan PotassiumLosartan PotassiumREMEDYREPACK INC.ANDACurrent
70518-1319Losartan PotassiumLosartan PotassiumREMEDYREPACK INC.ANDACurrent
70518-1319Losartan PotassiumLosartan PotassiumREMEDYREPACK INC.ANDACurrent
70518-1319Losartan PotassiumLosartan PotassiumREMEDYREPACK INC.ANDACurrent
70518-1319Losartan PotassiumLosartan PotassiumREMEDYREPACK INC.ANDACurrent
70934-942Losortan PotassiumLosartan PotassiumDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
71335-1644Losortan PotassiumLosartan PotassiumBryant Ranch PrepackANDACurrent
71335-1644Losortan PotassiumLosartan PotassiumBryant Ranch PrepackANDACurrent
72189-082LOSARTAN POTASSIUMLOSARTAN POTASSIUMDIRECT RXANDACurrent
72189-082LOSARTAN POTASSIUMLOSARTAN POTASSIUMDIRECT RXANDACurrent
82009-042Losortan PotassiumLosartan PotassiumQuallent Pharmaceuticals Health LLCANDACurrent
82009-042Losartan PotassiumLosartan PotassiumQuallent Pharmaceuticals Health LLCANDACurrent
82009-043Losortan PotassiumLosartan PotassiumQuallent Pharmaceuticals Health LLCANDACurrent
82009-043Losartan PotassiumLosartan PotassiumQuallent Pharmaceuticals Health LLCANDACurrent
82009-044Losortan PotassiumLosartan PotassiumQuallent Pharmaceuticals Health LLCANDACurrent
82009-044Losartan PotassiumLosartan PotassiumQuallent Pharmaceuticals Health LLCANDACurrent