Application 216908

Type: ANDA
Sponsor: TP ANDA HOLDINGS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	NAPROXEN	NAPROXEN	TABLET, DELAYED RELEASE;ORAL	375MG	No	No
002	NAPROXEN	NAPROXEN	TABLET, DELAYED RELEASE;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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A216908-001	NAPROXEN	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL	AB		2023-05-31
A216908-002	NAPROXEN	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL	AB		2023-05-31

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A216908-001	AB
A216908-002	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 2 · 48 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A216908-001	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL	AB	2023-05-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A216908-002	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	2023-05-31	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A216908-001	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL	AB	2023-05-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A216908-002	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	2023-05-31	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A216908-001	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL	AB	2023-05-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216908-002	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	2023-05-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216908-001	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL	AB	2023-05-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216908-002	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	2023-05-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A216908-001	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL	AB	2023-05-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A216908-002	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	2023-05-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216908-001	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL	AB	2023-05-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216908-002	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	2023-05-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216908-001	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL	AB	2023-05-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216908-002	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	2023-05-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216908-001	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL	AB	2023-05-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216908-002	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	2023-05-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216908-001	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL	AB	2023-05-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216908-002	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	2023-05-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216908-001	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL	AB	2023-05-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216908-002	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	2023-05-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216908-001	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL	AB	2023-05-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216908-002	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	2023-05-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A216908-001	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL	AB	2023-05-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A216908-002	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	2023-05-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216908-001	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL	AB	2023-05-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216908-002	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	2023-05-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216908-001	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL	AB	2023-05-31	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216908-002	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	2023-05-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216908-001	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL	AB	2023-05-31	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216908-002	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	2023-05-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A216908-001	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL	AB	2023-05-31	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A216908-002	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	2023-05-31	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A216908-001	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL	AB	2023-05-31	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A216908-002	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	2023-05-31	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A216908-001	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL	AB	2023-05-31	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A216908-002	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	2023-05-31	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A216908-001	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL	AB	2023-05-31	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A216908-002	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	2023-05-31	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A216908-001	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL	AB	2023-05-31	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A216908-002	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	2023-05-31	`a72a2bbeb626…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 48 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A216908-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A216908-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A216908-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A216908-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A216908-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216908-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216908-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216908-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A216908-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A216908-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216908-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216908-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216908-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216908-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216908-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216908-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216908-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216908-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216908-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216908-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216908-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216908-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A216908-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A216908-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216908-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216908-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216908-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216908-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216908-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216908-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A216908-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A216908-002	AB	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A216908-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A216908-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A216908-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A216908-002	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A216908-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A216908-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A216908-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A216908-002	AB	1	`a72a2bbeb626…`

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 6 of 8 · 141 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Naproxen	NAPROXEN	Bryant Ranch Prepack	1fe9a6fc-940e-4a18-b3e9-b204fd67f263	2024-09-03	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Naproxen generic name: NAPROXEN
Naproxen	NAPROXEN	Boswell Pharmacy Services LLC d/b/a BPS Wholesale	205b1159-06e5-0d48-e063-6294a90acbd8	2024-08-23	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Naproxen generic name: NAPROXEN
Naproxen	NAPROXEN	Bryant Ranch Prepack	a4f31070-4ee1-4d64-8b1d-40b9011e124b	2024-08-20	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Naproxen generic name: NAPROXEN
Naproxen	NAPROXEN	NuCare Pharmaceuticals,Inc.	5e873524-f9fb-fe2d-e053-2991aa0aa0a5	2024-08-14	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Naproxen generic name: NAPROXEN
Naproxen	NAPROXEN	NuCare Pharmaceuticals, Inc.	46dd3908-6feb-4f50-e054-00144ff88e88	2024-08-14	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Naproxen generic name: NAPROXEN
Naproxen	NAPROXEN	NuCare Pharmaceuticals, Inc.	3e8bcc59-dab1-1b4c-e054-00144ff88e88	2024-08-13	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Naproxen generic name: NAPROXEN
NAPROXEN	NAPROXEN	NuCare Pharmaceuticals,Inc.	5487dee2-5c37-4348-e054-00144ff8d46c	2024-07-17	Warnings	Name fallback brand name: NAPROXEN generic name: NAPROXEN
NAPROXEN	NAPROXEN	NuCare Pharmaceuticals,Inc.	71d4a048-ca50-73db-e053-2a95a90ad465	2024-06-10	Warnings	Name fallback brand name: NAPROXEN generic name: NAPROXEN
NAPROXEN	NAPROXEN	NuCare Pharmaceuticals,Inc.	69366b55-2687-17a4-e053-2a91aa0a65b3	2024-06-07		Name fallback brand name: NAPROXEN generic name: NAPROXEN
Naproxen	NAPROXEN	Bryant Ranch Prepack	74134b90-d4c7-41bd-a1bd-2ac168db596f	2024-04-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Naproxen generic name: NAPROXEN
Naproxen	NAPROXEN	Advanced Rx Pharmacy of Tennessee, LLC	1431b769-5535-78d6-e063-6394a90a8423	2024-03-21	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Naproxen generic name: NAPROXEN
Naproxen	NAPROXEN	Asclemed USA, Inc.	5a48c0d4-37bf-4c26-a9a7-5c67ff2adb4b	2024-03-19	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Naproxen generic name: NAPROXEN
Naproxen	NAPROXEN	Medsource Pharmaceuticals	12648efc-3be8-a915-e063-6394a90a3620	2024-02-27	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Naproxen generic name: NAPROXEN
Naproxen	NAPROXEN	Bryant Ranch Prepack	1cdcaba5-5550-40f6-94cc-b0a98cc17d3c	2024-01-11	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Naproxen generic name: NAPROXEN
Naproxen	NAPROXEN	Bryant Ranch Prepack	d564f52d-171c-4e7d-974c-3a0e192e6c12	2024-01-11	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Naproxen generic name: NAPROXEN
Naproxen	NAPROXEN	A-S Medication Solutions	f91c1a6b-b256-42e1-9da0-5f1975dec6ce	2023-12-27	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Naproxen generic name: NAPROXEN
Naproxen	NAPROXEN	A-S Medication Solutions	a8b54258-84e7-41e8-9e51-137a3f442e6b	2023-10-23	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Naproxen generic name: NAPROXEN
Naproxen	NAPROXEN	A-S Medication Solutions	80233fa5-f8b4-42d5-a8c9-4a1d8fd4aba4	2023-10-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Naproxen generic name: NAPROXEN
Naproxen	NAPROXEN	A-S Medication Solutions	50c52976-9e04-4a5e-9f21-aca3ea5c2924	2023-09-06	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Naproxen generic name: NAPROXEN
Naproxen	NAPROXEN	A-S Medication Solutions	d801ba16-e2ec-4bb2-8cff-32388634b35a	2023-09-06	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Naproxen generic name: NAPROXEN

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.