Application 020067

Type: NDA
Sponsor: ATNAHS PHARMA US

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
002	EC-NAPROSYN	NAPROXEN	TABLET, DELAYED RELEASE;ORAL	375MG	Yes	Yes
003	EC-NAPROSYN	NAPROXEN	TABLET, DELAYED RELEASE;ORAL	500MG	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N020067-002	EC-NAPROSYN	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	1994-10-14
N020067-003	EC-NAPROSYN	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	1994-10-14

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
N020067-002	AB
N020067-003	AB

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 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N020067-002	EC-NAPROSYN	375MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	1994-10-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020067-003	EC-NAPROSYN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	1994-10-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020067-002	EC-NAPROSYN	375MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	1994-10-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020067-003	EC-NAPROSYN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	1994-10-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020067-002	EC-NAPROSYN	375MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	1994-10-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020067-003	EC-NAPROSYN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	1994-10-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020067-002	EC-NAPROSYN	375MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	1994-10-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020067-003	EC-NAPROSYN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	1994-10-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020067-002	EC-NAPROSYN	375MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	1994-10-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020067-003	EC-NAPROSYN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	1994-10-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020067-002	EC-NAPROSYN	375MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	1994-10-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020067-003	EC-NAPROSYN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	1994-10-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020067-002	EC-NAPROSYN	375MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	1994-10-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020067-003	EC-NAPROSYN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	1994-10-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020067-002	EC-NAPROSYN	375MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	1994-10-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020067-003	EC-NAPROSYN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	1994-10-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020067-002	EC-NAPROSYN	375MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	1994-10-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020067-003	EC-NAPROSYN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	1994-10-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020067-002	EC-NAPROSYN	375MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	1994-10-14	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020067-003	EC-NAPROSYN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	1994-10-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020067-002	EC-NAPROSYN	375MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	1994-10-14	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020067-003	EC-NAPROSYN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	1994-10-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020067-002	EC-NAPROSYN	375MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	1994-10-14	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020067-003	EC-NAPROSYN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	1994-10-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020067-002	EC-NAPROSYN	375MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	1994-10-14	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020067-003	EC-NAPROSYN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	1994-10-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020067-002	EC-NAPROSYN	375MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	1994-10-14	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N020067-003	EC-NAPROSYN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	1994-10-14	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020067-002	EC-NAPROSYN	375MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	1994-10-14	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020067-003	EC-NAPROSYN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	1994-10-14	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020067-002	EC-NAPROSYN	375MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	1994-10-14	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N020067-003	EC-NAPROSYN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	1994-10-14	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020067-002	EC-NAPROSYN	375MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	1994-10-14	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020067-003	EC-NAPROSYN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	1994-10-14	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020067-002	EC-NAPROSYN	375MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	1994-10-14	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020067-003	EC-NAPROSYN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	1994-10-14	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020067-002	EC-NAPROSYN	375MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	1994-10-14	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N020067-003	EC-NAPROSYN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	1994-10-14	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020067-002	EC-NAPROSYN	375MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	1994-10-14	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N020067-003	EC-NAPROSYN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	1994-10-14	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N020067-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020067-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020067-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020067-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020067-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020067-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020067-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020067-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020067-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020067-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020067-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020067-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020067-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020067-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020067-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020067-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020067-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020067-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020067-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020067-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020067-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020067-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020067-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020067-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020067-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020067-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020067-002	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N020067-003	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020067-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020067-003	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020067-002	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N020067-003	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020067-002	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020067-003	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020067-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020067-003	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020067-002	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N020067-003	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020067-002	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N020067-003	AB	1	`782e0a99824c…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Naproxen	NAPROXEN	Zameer Pharmaceuticals LLC	d2e5553a-7c90-407c-9f07-3be65560c23a	2025-08-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 020067 application number: NDA020067

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 19 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0004-6415	EC-Naprosyn	naproxen	Genentech, Inc.	NDA	Current
42494-407	EC-NAPROXEN	naproxen	Cameron Pharmaceuticals, LLC	NDA	Current
42494-408	EC-NAPROXEN	naproxen	Cameron Pharmaceuticals, LLC	NDA	Current
63629-2484	EC-NAPROXEN	naproxen	Bryant Ranch Prepack	NDA	Current
63629-2484	EC-NAPROXEN	naproxen	Bryant Ranch Prepack	NDA	Current
69437-415	EC-Naprosyn	naproxen	Canton Laboratories	NDA	Current
69437-415	EC-Naprosyn	naproxen	Canton Laboratories	NDA	Current
69437-415	EC-Naprosyn	naproxen	Canton Laboratories	NDA	Current
69437-415	EC-Naprosyn	naproxen	Canton Laboratories	NDA	Current
69437-416	EC-Naprosyn	naproxen	Canton Laboratories	NDA	Current
69437-416	EC-Naprosyn	naproxen	Canton Laboratories	NDA	Current
69437-416	EC-Naprosyn	naproxen	Canton Laboratories	NDA	Current
69437-416	EC-Naprosyn	naproxen	Canton Laboratories	NDA	Current
69784-500	EC-NAPROXEN	naproxen	Woodward Pharma Services LLC	NDA	Current
69784-500	EC-NAPROXEN	naproxen	Woodward Pharma Services LLC	NDA	Current
69784-500	EC-NAPROXEN	naproxen	Woodward Pharma Services LLC	NDA	Current
69784-501	EC-NAPROXEN	naproxen	Woodward Pharma Services LLC	NDA	Current
69784-501	EC-NAPROXEN	naproxen	Woodward Pharma Services LLC	NDA	Current
69784-501	EC-NAPROXEN	naproxen	Woodward Pharma Services LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
80353	SUPPL	2024-11-25
80295	SUPPL	2024-11-22
80294	SUPPL	2024-11-22
78461	SUPPL	2024-05-14
78460	SUPPL	2024-05-14
67283	SUPPL	2021-04-30
67282	SUPPL	2021-04-30
67238	SUPPL	2021-04-29
59431	SUPPL	2019-07-23
59430	SUPPL	2019-07-23
59416	SUPPL	2019-07-23
47561	SUPPL	2017-03-14
47535	SUPPL	2017-03-13
34231	SUPPL	2016-05-11
1982	SUPPL	2016-05-11
12176	SUPPL	2013-03-26
1981	SUPPL	2013-03-26
21101	SUPPL	2008-07-30
12175	SUPPL	2008-07-29
12174	SUPPL	2007-09-26
1980	SUPPL	2007-09-25
1979	SUPPL	2007-04-25
1977	SUPPL	2006-03-23
34230	SUPPL	2006-03-14
1978	SUPPL	2006-01-30
12173	SUPPL	2006-01-25
34229	SUPPL	2004-11-16
21100	SUPPL	2004-11-16
12172	SUPPL	2004-11-16
1975	SUPPL	2004-11-16
1976	SUPPL	2003-06-08