Application 075927

Type
ANDA
Sponsor
AMNEAL PHARMS NY

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NAPROXENNAPROXENTABLET;ORAL250MGNoNo
002NAPROXENNAPROXENTABLET;ORAL375MGNoNo
003NAPROXENNAPROXENTABLET;ORAL500MGNoNo

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
A075927-001NAPROXENNAPROXEN250MGTABLET / ORALAB2001-12-18
A075927-002NAPROXENNAPROXEN375MGTABLET / ORALAB2001-12-18
A075927-003NAPROXENNAPROXEN500MGTABLET / ORALAB2001-12-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A075927-001AB
A075927-002AB
A075927-003AB

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 22:38:342026-08A075927-001NAPROXEN250MGTABLET / ORALAB2001-12-1884e616aacf4f…
2026-09-14 22:38:342026-08A075927-002NAPROXEN375MGTABLET / ORALAB2001-12-1884e616aacf4f…
2026-09-14 22:38:342026-08A075927-003NAPROXEN500MGTABLET / ORALAB2001-12-1884e616aacf4f…
2026-08-18 06:07:402026-07A075927-001NAPROXEN250MGTABLET / ORALAB2001-12-18caaa826d4ba7…
2026-08-18 06:07:402026-07A075927-002NAPROXEN375MGTABLET / ORALAB2001-12-18caaa826d4ba7…
2026-08-18 06:07:402026-07A075927-003NAPROXEN500MGTABLET / ORALAB2001-12-18caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A075927-001NAPROXEN250MGTABLET / ORALAB2001-12-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075927-002NAPROXEN375MGTABLET / ORALAB2001-12-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075927-003NAPROXEN500MGTABLET / ORALAB2001-12-18011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075927-001NAPROXEN250MGTABLET / ORALAB2001-12-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075927-002NAPROXEN375MGTABLET / ORALAB2001-12-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075927-003NAPROXEN500MGTABLET / ORALAB2001-12-1831067a03dcf5…
2025-08-23 18:47 UTC2025-08A075927-001NAPROXEN250MGTABLET / ORALAB2001-12-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075927-002NAPROXEN375MGTABLET / ORALAB2001-12-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075927-003NAPROXEN500MGTABLET / ORALAB2001-12-186a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075927-001NAPROXEN250MGTABLET / ORALAB2001-12-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075927-002NAPROXEN375MGTABLET / ORALAB2001-12-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075927-003NAPROXEN500MGTABLET / ORALAB2001-12-18fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075927-001NAPROXEN250MGTABLET / ORALAB2001-12-18b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075927-002NAPROXEN375MGTABLET / ORALAB2001-12-18b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075927-003NAPROXEN500MGTABLET / ORALAB2001-12-18b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075927-001NAPROXEN250MGTABLET / ORALAB2001-12-1803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075927-002NAPROXEN375MGTABLET / ORALAB2001-12-1803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075927-003NAPROXEN500MGTABLET / ORALAB2001-12-1803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075927-001NAPROXEN250MGTABLET / ORALAB2001-12-182680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075927-002NAPROXEN375MGTABLET / ORALAB2001-12-182680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075927-003NAPROXEN500MGTABLET / ORALAB2001-12-182680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075927-001NAPROXEN250MGTABLET / ORALAB2001-12-185bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075927-002NAPROXEN375MGTABLET / ORALAB2001-12-185bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075927-003NAPROXEN500MGTABLET / ORALAB2001-12-185bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075927-001NAPROXEN250MGTABLET / ORALAB2001-12-18d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075927-002NAPROXEN375MGTABLET / ORALAB2001-12-18d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075927-003NAPROXEN500MGTABLET / ORALAB2001-12-18d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075927-001NAPROXEN250MGTABLET / ORALAB2001-12-18d06236e962d9…
2024-10-29 15:01 UTC2024-10A075927-002NAPROXEN375MGTABLET / ORALAB2001-12-18d06236e962d9…
2024-10-29 15:01 UTC2024-10A075927-003NAPROXEN500MGTABLET / ORALAB2001-12-18d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075927-001NAPROXEN250MGTABLET / ORALAB2001-12-1879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075927-002NAPROXEN375MGTABLET / ORALAB2001-12-1879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075927-003NAPROXEN500MGTABLET / ORALAB2001-12-1879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075927-001NAPROXEN250MGTABLET / ORALAB2001-12-18301d65b070ca…

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 22:38:342026-08A075927-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A075927-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A075927-003AB184e616aacf4f…
2026-08-18 06:07:402026-07A075927-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A075927-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A075927-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A075927-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075927-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075927-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075927-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075927-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075927-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A075927-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075927-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075927-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075927-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075927-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075927-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075927-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075927-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075927-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075927-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075927-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075927-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075927-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075927-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075927-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075927-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075927-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075927-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075927-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075927-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075927-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075927-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A075927-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A075927-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075927-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075927-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075927-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075927-001AB1301d65b070ca…

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 · 18 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NaproxenNAPROXENPreferred Pharmaceuticals Inc.c5e52ddd-a909-487a-bb46-01ad356906652026-07-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075927
application number: ANDA075927
ndc (product): 68788-7090
NaproxenNAPROXENA-S Medication Solutionsc5c8b6fd-f3f5-4fed-823c-9a80386b27b12026-06-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075927
application number: ANDA075927
NaproxenNAPROXENAvPAKe6fbf8f1-b064-658d-17bb-e7d6320aa45f2026-03-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075927
application number: ANDA075927
NaproxenNAPROXENNorthwind Health Company, LLCab6ec2c9-5df9-346c-e053-2a95a90ac81d2026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075927
application number: ANDA075927
NaproxenNAPROXENQPharma, Inc.307aa67f-53b9-4c60-a328-091bbf6338d42025-12-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075927
application number: ANDA075927
NaproxenNAPROXENPD-Rx Pharmaceuticals, Inc.29d98cf3-a0f2-3f89-e054-00144ff88e882025-07-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075927
application number: ANDA075927
NaproxenNAPROXENPD-Rx Pharmaceuticals, Inc.6573681e-e9be-440f-a818-a533b744648e2025-07-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075927
application number: ANDA075927
NaproxenNAPROXENAmneal Pharmaceuticals LLCc43a43e2-e867-448d-8f59-3efc7c077cbc2025-05-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075927
application number: ANDA075927
ndc (product): 65162-190
NaproxenNAPROXENBryant Ranch Prepack9d7bc470-fbba-40a6-a56c-f681a3cee9cf2025-03-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075927
application number: ANDA075927
NaproxenNAPROXENAmneal Pharmaceuticals of New York LLC2718e0b7-1ce6-457e-bee9-11b634dfd3532025-03-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075927
application number: ANDA075927
NaproxenNAPROXENAdvanced Rx of Tennessee, LLCaf9ad850-57b5-a21d-e053-2a95a90ae68e2024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075927
application number: ANDA075927
ndc (product): 80425-0010
NaproxenNAPROXENAdvanced Rx of Tennessee, LLCaf9a94a8-3825-eabd-e053-2a95a90acd582024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075927
application number: ANDA075927
ndc (product): 80425-0049
NaproxenNAPROXENBryant Ranch Prepacka4f31070-4ee1-4d64-8b1d-40b9011e124b2024-08-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075927
application number: ANDA075927
ndc (product): 71335-0345
NaproxenNAPROXENA-S Medication Solutions80233fa5-f8b4-42d5-a8c9-4a1d8fd4aba42023-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075927
application number: ANDA075927
NaproxenNAPROXENA-S Medication Solutions21930f73-d3c2-4462-a487-74ed871b74b22023-02-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075927
application number: ANDA075927
NaproxenNAPROXENA-S Medication Solutionsa5ea3a84-7acd-4f24-9f0f-9f871ce1b5f42023-02-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075927
application number: ANDA075927
NaproxenNAPROXENProficient Rx LPfc3ee94a-adb7-411e-a662-2f2c6ddbabaf2021-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075927
application number: ANDA075927
NaproxenNAPROXENNCS HealthCare of KY, Inc dba Vangard Labs62a12771-bde9-4bc3-9ce9-672c8e31f0202017-10-12Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075927
application number: ANDA075927

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 · 212 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
65162-190NaproxenNaproxenAmneal Pharmaceuticals LLCANDACurrent
65162-190NaproxenNaproxenAmneal Pharmaceuticals LLCANDACurrent
65162-190NaproxenNaproxenAmneal Pharmaceuticals LLCANDACurrent
65162-190NaproxenNaproxenAmneal Pharmaceuticals LLCANDACurrent
66336-817NaproxenNaproxenDispensing Solutions, Inc.ANDACurrent
67046-546NaproxenNaproxenContract Pharmacy Services-PAANDACurrent
67296-0561NaproxenNaproxenRedPharm Drug, Inc.ANDACurrent
67296-0561NaproxenNaproxenRedPharm Drug, Inc.ANDACurrent
67296-0561NaproxenNaproxenRedPharm Drug, Inc.ANDACurrent
67296-1521NaproxenNaproxenRedPharm Drug, Inc.ANDACurrent
67296-1521NaproxenNaproxenRedPharm Drug, Inc.ANDACurrent
67296-1521NaproxenNaproxenRedPharm Drug, Inc.ANDACurrent
67296-1521NaproxenNaproxenRedPharm Drug, Inc.ANDACurrent
67544-456NaproxenNaproxenAphena Pharma Solutions - Tennessee, LLCANDACurrent
67544-475NaproxenNaproxenAphena Pharma Solutions - Tennessee, LLCANDACurrent
67544-679NaproxenNaproxenAphena Pharma Solutions - Tennessee, LLCANDACurrent
68071-3387NaproxenNaproxenNuCare Pharmaceuticals, Inc.ANDACurrent
68151-2894NaproxenNaproxenCarilion Materials ManagementANDACurrent
68387-800NaproxenNaproxenKeltman Pharmaceuticals Inc.ANDACurrent
68387-801NaproxenNaproxenKeltman Pharmaceuticals Inc.ANDACurrent
68387-802NaproxenNaproxenKeltman Pharmaceuticals Inc.ANDACurrent
68788-6421NaproxenNaproxenPreferred Pharmaceuticals Inc.ANDACurrent
68788-6421NaproxenNaproxenPreferred Pharmaceuticals Inc.ANDACurrent
68788-7090NaproxenNaproxenPreferred Pharmaceuticals Inc.ANDACurrent
68788-7090NaproxenNaproxenPreferred Pharmaceuticals Inc.ANDACurrent
68788-7090NaproxenNaproxenPreferred Pharmaceuticals Inc.ANDACurrent
68788-7090NaproxenNaproxenPreferred Pharmaceuticals Inc.ANDACurrent
68788-7090NaproxenNaproxenPreferred Pharmaceuticals Inc.ANDACurrent
68788-9906NaproxenNaproxenPreferred Pharmaceuticals, Inc.ANDACurrent
68788-9907NaproxenNaproxenPreferred Pharmaceuticals, Inc.ANDACurrent
69189-0190NaproxenNaproxenAvera McKennan HospitalANDACurrent
70518-0591NaproxenNaproxenREMEDYREPACK INC.ANDACurrent
70518-0591NaproxenNaproxenREMEDYREPACK INC.ANDACurrent
70518-1143NaproxenNaproxenREMEDYREPACK INC.ANDACurrent
70518-1143NaproxenNaproxenREMEDYREPACK INC.ANDACurrent
70518-1493NaproxenNaproxenREMEDYREPACK INC.ANDACurrent
70518-1493NaproxenNaproxenREMEDYREPACK INC.ANDACurrent
70934-254NaproxenNaproxenDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-746NaproxenNaproxenDenton Pharma, Inc. dba Northwind PharmaceuticalsANDACurrent
70934-746NaproxenNaproxenDenton Pharma, Inc. dba Northwind PharmaceuticalsANDACurrent
71335-0345NaproxenNaproxenBryant Ranch PrepackANDACurrent
71335-0345NaproxenNaproxenBryant Ranch PrepackANDACurrent
71335-0345NaproxenNaproxenBryant Ranch PrepackANDACurrent
75921-190NaproxenNaproxenLife Line Home Care Services, Inc.ANDACurrent
80425-0010NaprosynNaproxen 375mgAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0010NaproxenNaproxenAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0010NaproxenNaproxenAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0049NaprosynNaproxen 500mgAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0049NaprosynNaproxen 500mgAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0049NaprosynNaproxen 500mgAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0049NaproxenNaproxenAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0049NaproxenNaproxenAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent