Application 020353

Type
NDA
Sponsor
ALVOGEN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NAPRELANNAPROXEN SODIUMTABLET, EXTENDED RELEASE;ORALEQ 375MG BASEYesNo
002NAPRELANNAPROXEN SODIUMTABLET, EXTENDED RELEASE;ORALEQ 500MG BASEYesNo
003NAPRELANNAPROXEN SODIUMTABLET, EXTENDED RELEASE;ORALEQ 750MG BASEYesYes

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
N020353-001NAPRELANNAPROXEN SODIUMEQ 375MG BASETABLET, EXTENDED RELEASE / ORALABRLD1996-01-05
N020353-002NAPRELANNAPROXEN SODIUMEQ 500MG BASETABLET, EXTENDED RELEASE / ORALABRLD1996-01-05
N020353-003NAPRELANNAPROXEN SODIUMEQ 750MG BASETABLET, EXTENDED RELEASE / ORALABRLD, RS1996-01-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
N020353-001AB
N020353-002AB
N020353-003AB

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 UTC2026-02N020353-001NAPRELANEQ 375MG BASETABLET, EXTENDED RELEASE / ORALABRLD1996-01-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020353-002NAPRELANEQ 500MG BASETABLET, EXTENDED RELEASE / ORALABRLD1996-01-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020353-003NAPRELANEQ 750MG BASETABLET, EXTENDED RELEASE / ORALABRLD, RS1996-01-05011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020353-001NAPRELANEQ 375MG BASETABLET, EXTENDED RELEASE / ORALABRLD1996-01-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020353-002NAPRELANEQ 500MG BASETABLET, EXTENDED RELEASE / ORALABRLD1996-01-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020353-003NAPRELANEQ 750MG BASETABLET, EXTENDED RELEASE / ORALABRLD, RS1996-01-0531067a03dcf5…
2025-08-23 18:47 UTC2025-08N020353-001NAPRELANEQ 375MG BASETABLET, EXTENDED RELEASE / ORALABRLD1996-01-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020353-002NAPRELANEQ 500MG BASETABLET, EXTENDED RELEASE / ORALABRLD1996-01-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020353-003NAPRELANEQ 750MG BASETABLET, EXTENDED RELEASE / ORALABRLD, RS1996-01-056a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020353-001NAPRELANEQ 375MG BASETABLET, EXTENDED RELEASE / ORALABRLD1996-01-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020353-002NAPRELANEQ 500MG BASETABLET, EXTENDED RELEASE / ORALABRLD1996-01-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020353-003NAPRELANEQ 750MG BASETABLET, EXTENDED RELEASE / ORALABRLD, RS1996-01-05fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020353-001NAPRELANEQ 375MG BASETABLET, EXTENDED RELEASE / ORALABRLD1996-01-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020353-002NAPRELANEQ 500MG BASETABLET, EXTENDED RELEASE / ORALABRLD1996-01-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020353-003NAPRELANEQ 750MG BASETABLET, EXTENDED RELEASE / ORALABRLD, RS1996-01-05b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020353-001NAPRELANEQ 375MG BASETABLET, EXTENDED RELEASE / ORALABRLD1996-01-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020353-002NAPRELANEQ 500MG BASETABLET, EXTENDED RELEASE / ORALABRLD1996-01-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020353-003NAPRELANEQ 750MG BASETABLET, EXTENDED RELEASE / ORALABRLD, RS1996-01-0503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020353-001NAPRELANEQ 375MG BASETABLET, EXTENDED RELEASE / ORALABRLD1996-01-052680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020353-002NAPRELANEQ 500MG BASETABLET, EXTENDED RELEASE / ORALABRLD1996-01-052680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020353-003NAPRELANEQ 750MG BASETABLET, EXTENDED RELEASE / ORALABRLD, RS1996-01-052680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020353-001NAPRELANEQ 375MG BASETABLET, EXTENDED RELEASE / ORALABRLD1996-01-055bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020353-002NAPRELANEQ 500MG BASETABLET, EXTENDED RELEASE / ORALABRLD1996-01-055bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020353-003NAPRELANEQ 750MG BASETABLET, EXTENDED RELEASE / ORALABRLD, RS1996-01-055bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020353-001NAPRELANEQ 375MG BASETABLET, EXTENDED RELEASE / ORALABRLD1996-01-05d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020353-002NAPRELANEQ 500MG BASETABLET, EXTENDED RELEASE / ORALABRLD1996-01-05d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020353-003NAPRELANEQ 750MG BASETABLET, EXTENDED RELEASE / ORALABRLD, RS1996-01-05d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N020353-001NAPRELANEQ 375MG BASETABLET, EXTENDED RELEASE / ORALABRLD1996-01-05d06236e962d9…
2024-10-29 15:01 UTC2024-10N020353-002NAPRELANEQ 500MG BASETABLET, EXTENDED RELEASE / ORALABRLD1996-01-05d06236e962d9…
2024-10-29 15:01 UTC2024-10N020353-003NAPRELANEQ 750MG BASETABLET, EXTENDED RELEASE / ORALABRLD, RS1996-01-05d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020353-001NAPRELANEQ 375MG BASETABLET, EXTENDED RELEASE / ORALABRLD1996-01-0579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020353-002NAPRELANEQ 500MG BASETABLET, EXTENDED RELEASE / ORALABRLD1996-01-0579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020353-003NAPRELANEQ 750MG BASETABLET, EXTENDED RELEASE / ORALABRLD, RS1996-01-0579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020353-001NAPRELANEQ 375MG BASETABLET, EXTENDED RELEASE / ORALABRLD1996-01-05301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020353-002NAPRELANEQ 500MG BASETABLET, EXTENDED RELEASE / ORALABRLD1996-01-05301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020353-003NAPRELANEQ 750MG BASETABLET, EXTENDED RELEASE / ORALABRLD, RS1996-01-05301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020353-001NAPRELANEQ 375MG BASETABLET, EXTENDED RELEASE / ORALABRLD1996-01-051e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020353-002NAPRELANEQ 500MG BASETABLET, EXTENDED RELEASE / ORALABRLD1996-01-051e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020353-003NAPRELANEQ 750MG BASETABLET, EXTENDED RELEASE / ORALABRLD, RS1996-01-051e350fbaab3a…
2024-05-31 18:47 UTC2024-05N020353-001NAPRELANEQ 375MG BASETABLET, EXTENDED RELEASE / ORALABRLD1996-01-058072bd15b7f6…

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 UTC2026-02N020353-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020353-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020353-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020353-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020353-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020353-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N020353-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020353-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020353-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020353-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020353-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020353-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020353-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020353-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020353-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020353-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020353-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020353-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020353-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020353-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020353-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020353-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020353-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020353-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020353-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020353-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020353-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N020353-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10N020353-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10N020353-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020353-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020353-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020353-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020353-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020353-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020353-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020353-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020353-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020353-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N020353-001AB18072bd15b7f6…

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 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NaprelanNAPROXEN SODIUMUpsher-Smith Laboratories, LLCb8a51c9a-488e-4377-a041-436f6a2f88932026-01-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 020353
application number: NDA020353
Naproxen SodiumNAPROXEN SODIUMUpsher-Smith Laboratories, LLC7c22a2d6-821c-4f83-aead-e756aed930e52025-12-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 020353
application number: NDA020353
Naproxen SodiumNAPROXEN SODIUMAlvogen Inc.9225acaa-209f-958b-2c51-9a46995dec332024-07-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 020353
application number: NDA020353
ndc (product): 47781-153
ndc (product): 47781-155
ndc (product): 47781-154
NaprelanNAPROXEN SODIUMAlmatica Pharma LLCe633ff0b-eab7-f167-8d08-e9236e54042b2024-07-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 020353
application number: NDA020353
ndc (product): 52427-273
ndc (product): 52427-274
ndc (product): 52427-272
Naproxen SodiumNAPROXEN SODIUMSA3, LLC313dd447-4b9f-4e5b-8ca9-4a2a5a1a53d92019-04-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 020353
application number: NDA020353
ndc (product): 69420-1375

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 37 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
21695-905NAPRELANnaproxen sodiumRebel Distributors CorpNDACurrent
21695-906NAPRELANnaproxen sodiumRebel Distributors CorpNDACurrent
47781-153Naproxen SodiumNaproxen SodiumAlvogen Inc.NDA AUTHORIZED GENERICCurrent
47781-153Naproxen SodiumNaproxen SodiumAlvogen Inc.NDA AUTHORIZED GENERICCurrent
47781-153Naproxen SodiumNaproxen SodiumAlvogen Inc.NDA AUTHORIZED GENERICCurrent
47781-153Naproxen SodiumNaproxen SodiumAlvogen Inc.NDA AUTHORIZED GENERICCurrent
47781-153Naproxen SodiumNaproxen SodiumAlvogen Inc.NDA AUTHORIZED GENERICCurrent
47781-154Naproxen SodiumNaproxen SodiumAlvogen Inc.NDA AUTHORIZED GENERICCurrent
47781-154Naproxen SodiumNaproxen SodiumAlvogen Inc.NDA AUTHORIZED GENERICCurrent
47781-154Naproxen SodiumNaproxen SodiumAlvogen Inc.NDA AUTHORIZED GENERICCurrent
47781-154Naproxen SodiumNaproxen SodiumAlvogen Inc.NDA AUTHORIZED GENERICCurrent
47781-154Naproxen SodiumNaproxen SodiumAlvogen Inc.NDA AUTHORIZED GENERICCurrent
47781-155Naproxen SodiumNaproxen SodiumAlvogen Inc.NDA AUTHORIZED GENERICCurrent
47781-155Naproxen SodiumNaproxen SodiumAlvogen Inc.NDA AUTHORIZED GENERICCurrent
47781-155Naproxen SodiumNaproxen SodiumAlvogen Inc.NDA AUTHORIZED GENERICCurrent
47781-155Naproxen SodiumNaproxen SodiumAlvogen Inc.NDA AUTHORIZED GENERICCurrent
47781-155Naproxen SodiumNaproxen SodiumAlvogen Inc.NDA AUTHORIZED GENERICCurrent
52427-272NaprelanNaproxen SodiumALMATICA PHARMA INC.NDACurrent
52427-272NaprelanNaproxen SodiumALMATICA PHARMA INC.NDACurrent
52427-272NaprelanNaproxen SodiumALMATICA PHARMA INC.NDACurrent
52427-272NaprelanNaproxen SodiumAlmatica Pharma LLCNDACurrent
52427-272NaprelanNaproxen SodiumALMATICA PHARMA INC.NDACurrent
52427-273NaprelanNaproxen SodiumALMATICA PHARMA INC.NDACurrent
52427-273NaprelanNaproxen SodiumALMATICA PHARMA INC.NDACurrent
52427-273NaprelanNaproxen SodiumALMATICA PHARMA INC.NDACurrent
52427-273NaprelanNaproxen SodiumAlmatica Pharma LLCNDACurrent
52427-273NaprelanNaproxen SodiumALMATICA PHARMA INC.NDACurrent
52427-274NaprelanNaproxen SodiumALMATICA PHARMA INC.NDACurrent
52427-274NaprelanNaproxen SodiumALMATICA PHARMA INC.NDACurrent
52427-274NaprelanNaproxen SodiumALMATICA PHARMA INC.NDACurrent
52427-274NaprelanNaproxen SodiumAlmatica Pharma LLCNDACurrent
52427-274NaprelanNaproxen SodiumALMATICA PHARMA INC.NDACurrent
59630-375NaprelanNaproxen SodiumShionogi Inc.NDACurrent
59630-777NaprelanNaproxen SodiumShionogi Inc.NDACurrent
59630-850NaprelanNaproxen SodiumShionogi Inc.NDACurrent
69420-1375Naproxen SodiumNaproxen SodiumSA3, LLCNDA AUTHORIZED GENERICCurrent
71800-020Naproxen SodiumNaproxen SodiumInnovida Phamaceutique CorporationNDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
80346SUPPL 2024-11-25
80324SUPPL 2024-11-22
80323SUPPL 2024-11-22
67348SUPPL2021-05-03
67347SUPPL2021-05-03
67254SUPPL2021-04-29
59421SUPPL2019-07-23
59420SUPPL2019-07-23
59410SUPPL2019-07-23
49724SUPPL2017-09-13
2365SUPPL2016-05-12
2364SUPPL2016-05-12
34532SUPPL2016-05-11
12465SUPPL2016-05-11
43644ORIG2011-11-17
24809SUPPL2011-11-10
34531SUPPL2011-11-09
34530SUPPL2009-11-06
2363SUPPL2009-08-10
24808SUPPL2007-06-04
34529SUPPL2006-01-20
24807SUPPL2006-01-20
20601SUPPL2003-08-08