Application 091305

Type: ANDA
Sponsor: INVAGEN PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	NAPROXEN	NAPROXEN	TABLET;ORAL	250MG	No	No
002	NAPROXEN	NAPROXEN	TABLET;ORAL	375MG	No	No
003	NAPROXEN	NAPROXEN	TABLET;ORAL	500MG	No	No

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-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A091305-001	NAPROXEN	NAPROXEN	250MG	TABLET / ORAL	2011-08-24
A091305-002	NAPROXEN	NAPROXEN	375MG	TABLET / ORAL	2011-08-24
A091305-003	NAPROXEN	NAPROXEN	500MG	TABLET / ORAL	2011-08-24

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
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A091305-001	NAPROXEN	250MG	TABLET / ORAL	2011-08-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A091305-002	NAPROXEN	375MG	TABLET / ORAL	2011-08-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A091305-003	NAPROXEN	500MG	TABLET / ORAL	2011-08-24	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A091305-001	NAPROXEN	250MG	TABLET / ORAL	2011-08-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091305-002	NAPROXEN	375MG	TABLET / ORAL	2011-08-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091305-003	NAPROXEN	500MG	TABLET / ORAL	2011-08-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091305-001	NAPROXEN	250MG	TABLET / ORAL	2011-08-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091305-002	NAPROXEN	375MG	TABLET / ORAL	2011-08-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091305-003	NAPROXEN	500MG	TABLET / ORAL	2011-08-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091305-001	NAPROXEN	250MG	TABLET / ORAL	2011-08-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091305-002	NAPROXEN	375MG	TABLET / ORAL	2011-08-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091305-003	NAPROXEN	500MG	TABLET / ORAL	2011-08-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091305-001	NAPROXEN	250MG	TABLET / ORAL	2011-08-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091305-002	NAPROXEN	375MG	TABLET / ORAL	2011-08-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091305-003	NAPROXEN	500MG	TABLET / ORAL	2011-08-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091305-001	NAPROXEN	250MG	TABLET / ORAL	2011-08-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091305-002	NAPROXEN	375MG	TABLET / ORAL	2011-08-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091305-003	NAPROXEN	500MG	TABLET / ORAL	2011-08-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091305-001	NAPROXEN	250MG	TABLET / ORAL	2011-08-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091305-002	NAPROXEN	375MG	TABLET / ORAL	2011-08-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091305-003	NAPROXEN	500MG	TABLET / ORAL	2011-08-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091305-001	NAPROXEN	250MG	TABLET / ORAL	2011-08-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091305-002	NAPROXEN	375MG	TABLET / ORAL	2011-08-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091305-003	NAPROXEN	500MG	TABLET / ORAL	2011-08-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091305-001	NAPROXEN	250MG	TABLET / ORAL	2011-08-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091305-002	NAPROXEN	375MG	TABLET / ORAL	2011-08-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091305-003	NAPROXEN	500MG	TABLET / ORAL	2011-08-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091305-001	NAPROXEN	250MG	TABLET / ORAL	2011-08-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091305-002	NAPROXEN	375MG	TABLET / ORAL	2011-08-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091305-003	NAPROXEN	500MG	TABLET / ORAL	2011-08-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091305-001	NAPROXEN	250MG	TABLET / ORAL	2011-08-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091305-002	NAPROXEN	375MG	TABLET / ORAL	2011-08-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091305-003	NAPROXEN	500MG	TABLET / ORAL	2011-08-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091305-001	NAPROXEN	250MG	TABLET / ORAL	2011-08-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091305-002	NAPROXEN	375MG	TABLET / ORAL	2011-08-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091305-003	NAPROXEN	500MG	TABLET / ORAL	2011-08-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091305-001	NAPROXEN	250MG	TABLET / ORAL	2011-08-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091305-002	NAPROXEN	375MG	TABLET / ORAL	2011-08-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091305-003	NAPROXEN	500MG	TABLET / ORAL	2011-08-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091305-001	NAPROXEN	250MG	TABLET / ORAL	2011-08-24	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 2 · 78 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091305-002	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091305-003	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A091305-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A091305-002	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A091305-003	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A091305-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A091305-002	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A091305-003	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091305-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091305-002	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091305-003	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091305-001	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091305-002	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091305-003	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091305-001	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091305-002	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091305-003	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091305-001	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091305-002	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091305-003	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A091305-001	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A091305-002	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A091305-003	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A091305-001	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A091305-002	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A091305-003	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091305-001	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091305-002	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091305-003	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A091305-001	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A091305-002	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A091305-003	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A091305-001	AB	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A091305-002	AB	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A091305-003	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A091305-001	AB	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A091305-002	AB	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A091305-003	AB	1	`cb3db0bc1861…`

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
naproxen	NAPROXEN	Cipla USA Inc.	a9549a47-3fa4-4a2b-95ac-b00e43aedae7	2023-01-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091305 application number: ANDA091305 ndc (product): 69097-855 ndc (product): 69097-854 ndc (product): 69097-853
Naproxen	NAPROXEN	Exelan Pharmaceuticals, Inc.	46dbdb95-a0d0-4410-8d64-b22763b12af7	2020-08-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091305 application number: ANDA091305 ndc (product): 76282-341 ndc (product): 76282-340 ndc (product): 76282-342
Naproxen	NAPROXEN	Aphena Pharma Solutions - Tennessee, LLC	e2347581-90da-429a-b17c-cffd0039fb86	2017-10-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091305 application number: ANDA091305 ndc (product): 43353-216 ndc (product): 43353-211 ndc (product): 43353-218

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 1 of 1 · 51 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
10544-939	Naproxen	Naproxen	Blenheim Pharmacal, Inc.	ANDA	Current
31722-340	Naproxen	Naproxen	Camber Pharmaceuticals	ANDA	Current
31722-341	Naproxen	Naproxen	Camber Pharmaceuticals	ANDA	Current
31722-342	Naproxen	Naproxen	Camber Pharmaceuticals	ANDA	Current
43353-201	Naproxen	Naproxen	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
43353-211	Naproxen	Naproxen	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
43353-216	Naproxen	Naproxen	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
43353-218	Naproxen	Naproxen	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
50090-4396	naproxen	naproxen	A-S Medication Solutions	ANDA	Current
53002-3100	naproxen	naproxen	RPK Pharmaceuticals, Inc.	ANDA	Current
53002-3100	naproxen	naproxen	RPK Pharmaceuticals, Inc.	ANDA	Current
53002-3100	naproxen	naproxen	RPK Pharmaceuticals, Inc.	ANDA	Current
53002-3112	naproxen	naproxen	RPK Pharmaceuticals, Inc.	ANDA	Current
53002-3112	naproxen	naproxen	RPK Pharmaceuticals, Inc.	ANDA	Current
53002-3112	naproxen	naproxen	RPK Pharmaceuticals, Inc.	ANDA	Current
53002-3240	naproxen	naproxen	RPK Pharmaceuticals, Inc.	ANDA	Current
53002-3240	naproxen	naproxen	RPK Pharmaceuticals, Inc.	ANDA	Current
53002-3240	naproxen	naproxen	RPK Pharmaceuticals, Inc.	ANDA	Current
53808-1053	Naproxen	Naproxen	State of Florida DOH Central Pharmacy	ANDA	Current
55700-463	naproxen	naproxen	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
60687-268	Naproxen	Naproxen	American Health Packaging	ANDA	Current
60687-268	Naproxen	Naproxen	American Health Packaging	ANDA	Current
60760-460	Naproxen	Naproxen	St. Mary's Medical Park Pharmacy	ANDA	Current
61919-586	NAPROXEN	NAPROXEN	DirectRX	ANDA	Current
61919-586	NAPROXEN	NAPROXEN	DirectRX	ANDA	Current
67296-1374	naproxen	naproxen	RedPharm Drug, Inc.	ANDA	Current
68071-3029	naproxen	naproxen	NuCare Pharmaceuticals, Inc.	ANDA	Current
68071-3066	naproxen	naproxen	NuCare Pharmaceuticals, Inc.	ANDA	Current
68788-7456	naproxen	naproxen	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-9878	Naproxen	Naproxen	Preferred Pharmaceuticals Inc.	ANDA	Current
69097-853	naproxen	naproxen	Cipla USA Inc.	ANDA	Current
69097-853	naproxen	naproxen	Cipla USA Inc.	ANDA	Current
69097-854	naproxen	naproxen	Cipla USA Inc.	ANDA	Current
69097-854	naproxen	naproxen	Cipla USA Inc.	ANDA	Current
69097-855	naproxen	naproxen	Cipla USA Inc.	ANDA	Current
69097-855	naproxen	naproxen	Cipla USA Inc.	ANDA	Current
70518-0596	naproxen	naproxen	REMEDYREPACK INC.	ANDA	Current
70518-0596	naproxen	naproxen	REMEDYREPACK INC.	ANDA	Current
70518-1511	naproxen	naproxen	REMEDYREPACK INC.	ANDA	Current
70518-1511	naproxen	naproxen	REMEDYREPACK INC.	ANDA	Current
71335-0386	naproxen	naproxen	Bryant Ranch Prepack	ANDA	Current
71335-0386	naproxen	naproxen	Bryant Ranch Prepack	ANDA	Current
76282-340	Naproxen	Naproxen	Exelan Pharmaceuticals, Inc.	ANDA	Current
76282-340	Naproxen	Naproxen	Exelan Pharmaceuticals, Inc.	ANDA	Current
76282-340	Naproxen	Naproxen	Exelan Pharmaceuticals, Inc.	ANDA	Current
76282-341	Naproxen	Naproxen	Exelan Pharmaceuticals, Inc.	ANDA	Current
76282-341	Naproxen	Naproxen	Exelan Pharmaceuticals, Inc.	ANDA	Current
76282-341	Naproxen	Naproxen	Exelan Pharmaceuticals, Inc.	ANDA	Current
76282-342	Naproxen	Naproxen	Exelan Pharmaceuticals, Inc.	ANDA	Current
76282-342	Naproxen	Naproxen	Exelan Pharmaceuticals, Inc.	ANDA	Current
76282-342	Naproxen	Naproxen	Exelan Pharmaceuticals, Inc.	ANDA	Current