Application 091416

Type
ANDA
Sponsor
MARKSANS PHARMA

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 1.

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
A091416-001NAPROXENNAPROXEN250MGTABLET / ORALAB2011-02-14
A091416-002NAPROXENNAPROXEN375MGTABLET / ORALAB2011-02-14
A091416-003NAPROXENNAPROXEN500MGTABLET / ORALAB2011-02-14

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A091416-001AB
A091416-002AB
A091416-003AB

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 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A091416-001NAPROXEN250MGTABLET / ORALAB2011-02-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091416-002NAPROXEN375MGTABLET / ORALAB2011-02-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091416-003NAPROXEN500MGTABLET / ORALAB2011-02-14011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091416-001NAPROXEN250MGTABLET / ORALAB2011-02-1431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091416-002NAPROXEN375MGTABLET / ORALAB2011-02-1431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091416-003NAPROXEN500MGTABLET / ORALAB2011-02-1431067a03dcf5…
2025-08-23 18:47 UTC2025-08A091416-001NAPROXEN250MGTABLET / ORALAB2011-02-146a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091416-002NAPROXEN375MGTABLET / ORALAB2011-02-146a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091416-003NAPROXEN500MGTABLET / ORALAB2011-02-146a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091416-001NAPROXEN250MGTABLET / ORALAB2011-02-14fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091416-002NAPROXEN375MGTABLET / ORALAB2011-02-14fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091416-003NAPROXEN500MGTABLET / ORALAB2011-02-14fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091416-001NAPROXEN250MGTABLET / ORALAB2011-02-14b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091416-002NAPROXEN375MGTABLET / ORALAB2011-02-14b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091416-003NAPROXEN500MGTABLET / ORALAB2011-02-14b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091416-001NAPROXEN250MGTABLET / ORALAB2011-02-1403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091416-002NAPROXEN375MGTABLET / ORALAB2011-02-1403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091416-003NAPROXEN500MGTABLET / ORALAB2011-02-1403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091416-001NAPROXEN250MGTABLET / ORALAB2011-02-142680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091416-002NAPROXEN375MGTABLET / ORALAB2011-02-142680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091416-003NAPROXEN500MGTABLET / ORALAB2011-02-142680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091416-001NAPROXEN250MGTABLET / ORALAB2011-02-145bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091416-002NAPROXEN375MGTABLET / ORALAB2011-02-145bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091416-003NAPROXEN500MGTABLET / ORALAB2011-02-145bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091416-001NAPROXEN250MGTABLET / ORALAB2011-02-14d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091416-002NAPROXEN375MGTABLET / ORALAB2011-02-14d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091416-003NAPROXEN500MGTABLET / ORALAB2011-02-14d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A091416-001NAPROXEN250MGTABLET / ORALAB2011-02-14d06236e962d9…
2024-10-29 15:01 UTC2024-10A091416-002NAPROXEN375MGTABLET / ORALAB2011-02-14d06236e962d9…
2024-10-29 15:01 UTC2024-10A091416-003NAPROXEN500MGTABLET / ORALAB2011-02-14d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091416-001NAPROXEN250MGTABLET / ORALAB2011-02-1479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091416-002NAPROXEN375MGTABLET / ORALAB2011-02-1479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091416-003NAPROXEN500MGTABLET / ORALAB2011-02-1479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091416-001NAPROXEN250MGTABLET / ORALAB2011-02-14301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091416-002NAPROXEN375MGTABLET / ORALAB2011-02-14301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091416-003NAPROXEN500MGTABLET / ORALAB2011-02-14301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091416-001NAPROXEN250MGTABLET / ORALAB2011-02-141e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091416-002NAPROXEN375MGTABLET / ORALAB2011-02-141e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091416-003NAPROXEN500MGTABLET / ORALAB2011-02-141e350fbaab3a…
2024-05-31 18:47 UTC2024-05A091416-001NAPROXEN250MGTABLET / ORALAB2011-02-148072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A091416-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091416-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091416-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091416-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091416-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091416-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A091416-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091416-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091416-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091416-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091416-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091416-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091416-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091416-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091416-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091416-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091416-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091416-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091416-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091416-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091416-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091416-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091416-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091416-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091416-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091416-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091416-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A091416-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A091416-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A091416-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091416-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091416-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091416-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091416-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091416-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091416-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091416-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091416-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091416-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A091416-001AB18072bd15b7f6…

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
NAPROXENNAPROXENNorthwind Health Company, LLCf32d755e-4984-ee40-e053-2995a90a4ebe2026-01-01WarningsExact identifier
application applno (ANDA): 091416
application number: ANDA091416
NAPROXENNAPROXENQPharma Incc0a4839b-7154-c82c-e053-2a95a90a7e6d2025-12-03WarningsExact identifier
application applno (ANDA): 091416
application number: ANDA091416
ndc (product): 42708-140
NAPROXENNAPROXENPD-Rx Pharmaceuticals, Inc.a9f9ce81-9d51-4167-9581-974866a8fe312025-10-17WarningsExact identifier
application applno (ANDA): 091416
application number: ANDA091416
ndc (product): 43063-920
NAPROXENNAPROXENDIRECT RXb1b78c49-82e9-2402-e053-2a95a90ae35f2025-01-17WarningsExact identifier
application applno (ANDA): 091416
application number: ANDA091416
NaproxenNAPROXENAdvanced Rx of Tennessee, LLCaf9a96cf-1cda-8ace-e053-2a95a90a18cc2024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091416
application number: ANDA091416
NaproxenNAPROXENMARKSANS PHARMA LIMITED1fdb4cbd-e9e8-47bb-b3d8-1f1ec8f411c82024-12-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091416
application number: ANDA091416
ndc (product): 25000-138
ndc (product): 25000-140
ndc (product): 25000-139
NAPROXENNAPROXENNuCare Pharmaceuticals,Inc.5487dee2-5c37-4348-e054-00144ff8d46c2024-07-17WarningsExact identifier
application applno (ANDA): 091416
application number: ANDA091416
ndc (product): 68071-4006
NAPROXENNAPROXENNuCare Pharmaceuticals,Inc.71d4a048-ca50-73db-e053-2a95a90ad4652024-06-10WarningsExact identifier
application applno (ANDA): 091416
application number: ANDA091416
ndc (product): 68071-4510
NAPROXENNAPROXENNuCare Pharmaceuticals,Inc.69366b55-2687-17a4-e053-2a91aa0a65b32024-06-07Exact identifier
application applno (ANDA): 091416
application number: ANDA091416
ndc (product): 68071-4381
NAPROXENNAPROXENAsclemed USA, Inc.a4fcb411-c918-459b-adc6-06dfa8ed8a502022-10-12WarningsExact identifier
application applno (ANDA): 091416
application number: ANDA091416
NAPROXENNAPROXENAphena Pharma Solutions - Tennessee, LLC32693390-763b-46dd-b821-65a7bf3c66712021-04-26WarningsExact identifier
application applno (ANDA): 091416
application number: ANDA091416
ndc (product): 71610-436
NAPROXENNAPROXENBryant Ranch Prepack5d399bf3-db49-411a-91b9-b410d702a65a2020-12-14WarningsExact identifier
application applno (ANDA): 091416
application number: ANDA091416
ndc (product): 71335-0255
ndc (product): 71335-0973
NAPROXENNAPROXENTIME CAP LABORATORIES4350a2d9-5228-460e-b7b1-27e8fa8467872018-10-09WarningsExact identifier
application applno (ANDA): 091416
application number: ANDA091416
ndc (product): 49483-618
ndc (product): 49483-619
ndc (product): 49483-617

NDC Listings For This Application#

NDC listings for this application page 1 of 2 · 89 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
10544-111NAPROXENNAPROXENBlenheim Pharmacal, Inc.ANDACurrent
25000-138NaproxenNaproxenMARKSANS PHARMA LIMITEDANDACurrent
25000-138NaproxenNaproxenMARKSANS PHARMA LIMITEDANDACurrent
25000-138NaproxenNaproxenMARKSANS PHARMA LIMITEDANDACurrent
25000-138NaproxenNaproxenMARKSANS PHARMA LIMITEDANDACurrent
25000-139NaproxenNaproxenMARKSANS PHARMA LIMITEDANDACurrent
25000-139NaproxenNaproxenMARKSANS PHARMA LIMITEDANDACurrent
25000-139NaproxenNaproxenMARKSANS PHARMA LIMITEDANDACurrent
25000-139NaproxenNaproxenMARKSANS PHARMA LIMITEDANDACurrent
25000-140NaproxenNaproxenMARKSANS PHARMA LIMITEDANDACurrent
25000-140NaproxenNaproxenMARKSANS PHARMA LIMITEDANDACurrent
25000-140NaproxenNaproxenMARKSANS PHARMA LIMITEDANDACurrent
25000-140NaproxenNaproxenMARKSANS PHARMA LIMITEDANDACurrent
42708-140NAPROXENNAPROXENQPharma IncANDACurrent
43063-920NAPROXENNAPROXENPD-Rx Pharmaceuticals, InANDACurrent
43063-920NAPROXENNAPROXENPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-920NAPROXENNAPROXENPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-920NAPROXENNAPROXENPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-920NAPROXENNAPROXENPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-920NAPROXENNAPROXENPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-920NAPROXENNAPROXENPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-920NAPROXENNAPROXENPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-920NAPROXENNAPROXENPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-920NAPROXENNAPROXENPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-937NAPROXENNAPROXENPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-937NAPROXENNAPROXENPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-937NAPROXENNAPROXENPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-937NAPROXENNAPROXENPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-937NAPROXENNAPROXENPD-Rx Pharmaceuticals, Inc.ANDACurrent
45865-581NAPROXENNAPROXENmedsource pharmaceuticalsANDACurrent
49483-617NAPROXENNAPROXENTIME CAP LABORATORIESANDACurrent
49483-618NAPROXENNAPROXENTIME CAP LABORATORIESANDACurrent
49483-619NAPROXENNAPROXENTIME CAP LABORATORIESANDACurrent
50436-0618NAPROXENNAPROXENUnit Dose ServicesANDACurrent
52605-138NAPROXENNAPROXENPolygen Pharmaceuticals LLCANDACurrent
52605-139NAPROXENNAPROXENPolygen Pharmaceuticals LLCANDACurrent
52605-140NAPROXENNAPROXENPolygen Pharmaceuticals LLCANDACurrent
52959-193NAPROXENNAPROXENH.J. Harkins Company., Inc.ANDACurrent
53002-3110NAPROXENNAPROXENRPK Pharmaceuticals, Inc.ANDACurrent
53002-3110NAPROXENNAPROXENRPK Pharmaceuticals, Inc.ANDACurrent
60760-561NAPROXENNAPROXENSt. Mary's Medical Park PharmacyANDACurrent
66336-815NAPROXENNAPROXENDispensing Solutions, Inc.ANDACurrent
67296-1609NAPROXENNAPROXENRedPharm Drug, Inc.ANDACurrent
67296-1609NAPROXENNAPROXENRedPharm Drug, Inc.ANDACurrent
67296-1609NAPROXENNAPROXENRedPharm Drug, Inc.ANDACurrent
68071-3345NAPROXENNAPROXENNuCare Pharmaceuticals,Inc.ANDACurrent
68071-3345NAPROXENNAPROXENNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4006NAPROXENNAPROXENNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4006NAPROXENNAPROXENNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4381NAPROXENNAPROXENNuCare Pharmaceuticals,InANDACurrent
68071-4381NAPROXENNAPROXENNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4381NAPROXENNAPROXENNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4510NAPROXENNAPROXENNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4510NAPROXENNAPROXENNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4510NAPROXENNAPROXENNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4995NAPROXENNAPROXENNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4995NAPROXENNAPROXENNuCare Pharmaceuticals,Inc.ANDACurrent
68788-6998NAPROXENNAPROXENPreferred Pharmaceuticals Inc.ANDACurrent
68788-7711NAPROXENNAPROXENPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7711NAPROXENNAPROXENPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7711NAPROXENNAPROXENPreferred Pharmaceuticals, Inc.ANDACurrent
69150-138NAPROXENNAPROXENBiomes PharmaceuticalsANDACurrent
69150-139NAPROXENNAPROXENBiomes PharmaceuticalsANDACurrent
69150-140NAPROXENNAPROXENBiomes PharmaceuticalsANDACurrent
70518-2428NAPROXENNAPROXENREMEDYREPACK INC.ANDACurrent
70518-2428NAPROXENNAPROXENREMEDYREPACK INC.ANDACurrent
70518-2428NAPROXENNAPROXENREMEDYREPACK INC.ANDACurrent
70934-124NAPROXENNAPROXENDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-124NAPROXENNAPROXENDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-124NAPROXENNAPROXENDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-455NAPROXENNAPROXENDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-455NAPROXENNAPROXENDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
71335-0255NAPROXENNAPROXENBryant Ranch PrepackANDACurrent
71335-0255NAPROXENNAPROXENBryant Ranch PrepackANDACurrent
71335-0255NAPROXENNAPROXENBryant Ranch PrepackANDACurrent
71335-0973NAPROXENNAPROXENBryant Ranch PrepackANDACurrent
71335-0973NAPROXENNAPROXENBryant Ranch PrepackANDACurrent
71335-0973NAPROXENNAPROXENBryant Ranch PrepackANDACurrent
71335-0973NAPROXENNAPROXENBryant Ranch PrepackANDACurrent
71610-436NAPROXENNAPROXENAphena Pharma Solutions - Tennessee, LLCANDACurrent