Application 212199

Type: ANDA
Sponsor: SCIEGEN PHARMS INC

Application Products#

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

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
A212199-001	NAPROXEN SODIUM	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	AB		2019-10-30
A212199-002	NAPROXEN SODIUM	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	AB		2019-10-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A212199-001	AB
A212199-002	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 · 78 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
2026-02-19 14:30 UTC	2026-02	A212199-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	AB	2019-10-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212199-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	AB	2019-10-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212199-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	AB	2019-10-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212199-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	AB	2019-10-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212199-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	AB	2019-10-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212199-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	AB	2019-10-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212199-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	AB	2019-10-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212199-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	AB	2019-10-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212199-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	AB	2019-10-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212199-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	AB	2019-10-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212199-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	AB	2019-10-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212199-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	AB	2019-10-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212199-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	AB	2019-10-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212199-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	AB	2019-10-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212199-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	AB	2019-10-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212199-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	AB	2019-10-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212199-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	AB	2019-10-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212199-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	AB	2019-10-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212199-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	AB	2019-10-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212199-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	AB	2019-10-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212199-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	AB	2019-10-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212199-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	AB	2019-10-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212199-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	AB	2019-10-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212199-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	AB	2019-10-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212199-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	AB	2019-10-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212199-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	AB	2019-10-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212199-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	AB	2019-10-30	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A212199-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	AB	2019-10-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212199-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	AB	2019-10-30	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212199-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	AB	2019-10-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212199-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	AB	2019-10-30	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A212199-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	AB	2019-10-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212199-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	AB	2019-10-30	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A212199-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	AB	2019-10-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A212199-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	AB	2019-10-30	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A212199-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	AB	2019-10-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A212199-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	AB	2019-10-30	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A212199-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	AB	2019-10-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212199-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	AB	2019-10-30	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A212199-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	AB	2019-10-30	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 78 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	A212199-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212199-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212199-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212199-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212199-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212199-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212199-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212199-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212199-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212199-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212199-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212199-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212199-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212199-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212199-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212199-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212199-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212199-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212199-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212199-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212199-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212199-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212199-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212199-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212199-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212199-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212199-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A212199-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212199-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212199-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212199-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A212199-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212199-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A212199-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A212199-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A212199-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A212199-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A212199-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212199-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A212199-002	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 · 14 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Naproxen Sodium	NAPROXEN SODIUM	ScieGen Pharmaceuticals, Inc.	79f48c92-783d-40f2-9865-89958a9f9de6	2026-07-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212199 application number: ANDA212199 ndc (product): 50228-432 ndc (product): 50228-433
Naproxen Sodium	NAPROXEN SODIUM	ST. MARY'S MEDICAL PARK PHARMACY	181c2d5b-2c61-bf20-e063-6294a90a3f7f	2026-05-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212199 application number: ANDA212199
Naproxen Sodium	NAPROXEN SODIUM	Bryant Ranch Prepack	2794b60d-d09b-4115-9ff2-07ff15524e78	2026-05-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212199 application number: ANDA212199
Naproxen Sodium	NAPROXEN SODIUM	Bryant Ranch Prepack	bee7b482-8ba5-411d-90ee-de00df50d2b7	2026-04-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212199 application number: ANDA212199 ndc (product): 63629-8516
Naproxen Sodium	NAPROXEN SODIUM	Bryant Ranch Prepack	e9eb8c40-85d9-4c8e-9523-a21d3591260f	2026-04-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212199 application number: ANDA212199 ndc (product): 63629-8517
Naproxen Sodium	NAPROXEN SODIUM	Bryant Ranch Prepack	f6f4a670-235e-4235-84a8-a74dc8ca5586	2026-04-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212199 application number: ANDA212199
Naproxen Sodium	NAPROXEN SODIUM	Advanced Rx of Tennessee, LLC	369911ea-9069-9c45-e063-6394a90a5ce6	2026-02-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212199 application number: ANDA212199
Naproxen Sodium	NAPROXEN SODIUM	Advanced Rx of Tennessee, LLC	4a05ca8c-1b03-fa86-e063-6394a90a4119	2026-02-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212199 application number: ANDA212199
Naproxen Sodium	NAPROXEN SODIUM	PD-Rx Pharmaceuticals, Inc.	145cdcc0-9bd5-4a0e-81fc-11a24d181980	2026-01-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212199 application number: ANDA212199
Naproxen Sodium	NAPROXEN SODIUM	Preferred Pharmaceuticals, Inc.	6ae413ba-5a48-423f-8b8d-7a42661cf836	2025-08-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212199 application number: ANDA212199 ndc (product): 68788-7800
Naproxen Sodium	NAPROXEN SODIUM	Direct Rx	d95279d9-6e2a-0bd6-e053-2a95a90a447d	2025-01-21		Exact identifier application applno (ANDA): 212199 application number: ANDA212199 ndc (product): 72189-332
Naproxen Sodium	NAPROXEN SODIUM	NuCare Pharmaceuticals,Inc.	b8e417d2-3fc8-9a5e-e053-2a95a90a4155	2025-01-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212199 application number: ANDA212199 ndc (product): 68071-2333
Naproxen Sodium	NAPROXEN SODIUM	Asclemed USA, Inc.	b0571e62-9330-438d-a2ba-873477f52dc4	2023-10-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212199 application number: ANDA212199
Naproxen Sodium	NAPROXEN SODIUM	Proficient Rx LP	a90bfc07-d01e-427c-b2df-41bff7612d2f	2022-07-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212199 application number: ANDA212199 ndc (product): 71205-631

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 22 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50228-432	Naproxen Sodium	Naproxen Sodium	ScieGen Pharmaceuticals, Inc.	ANDA	Current
50228-432	Naproxen Sodium	Naproxen Sodium	ScieGen Pharmaceuticals, Inc.	ANDA	Current
50228-432	Naproxen Sodium	Naproxen Sodium	ScieGen Pharmaceuticals, Inc.	ANDA	Current
50228-433	Naproxen Sodium	Naproxen Sodium	ScieGen Pharmaceuticals, Inc.	ANDA	Current
50228-433	Naproxen Sodium	Naproxen Sodium	ScieGen Pharmaceuticals, Inc.	ANDA	Current
50228-433	Naproxen Sodium	Naproxen Sodium	ScieGen Pharmaceuticals, Inc.	ANDA	Current
63629-8516	Naproxen Sodium	Naproxen Sodium	Bryant Ranch Prepack	ANDA	Current
63629-8516	Naproxen Sodium	Naproxen Sodium	Bryant Ranch Prepack	ANDA	Current
63629-8516	Naproxen Sodium	Naproxen Sodium	Bryant Ranch Prepack	ANDA	Current
63629-8517	Naproxen Sodium	Naproxen Sodium	Bryant Ranch Prepack	ANDA	Current
63629-8517	Naproxen Sodium	Naproxen Sodium	Bryant Ranch Prepack	ANDA	Current
63629-8517	Naproxen Sodium	Naproxen Sodium	Bryant Ranch Prepack	ANDA	Current
68071-2333	Naproxen Sodium	Naproxen Sodium	NuCare Pharmaceuticals,Inc.	ANDA	Current
68788-7800	Naproxen Sodium	Naproxen Sodium	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-7800	Naproxen Sodium	Naproxen Sodium	Preferred Pharmaceuticals, Inc.	ANDA	Current
70518-2863	Naproxen Sodium	Naproxen Sodium	REMEDYREPACK INC.	ANDA	Current
70518-2863	Naproxen Sodium	Naproxen Sodium	REMEDYREPACK INC.	ANDA	Current
70518-2863	Naproxen Sodium	Naproxen Sodium	REMEDYREPACK INC.	ANDA	Current
70934-936	Naproxen Sodium	Naproxen Sodium	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
71205-631	Naproxen Sodium	Naproxen Sodium	Proficient Rx LP	ANDA	Current
71205-631	Naproxen Sodium	Naproxen Sodium	Proficient Rx LP	ANDA	Current
72189-332	Naproxen Sodium	Naproxen Sodium	Direct Rx	ANDA	Current