Application 213663

Type: ANDA
Sponsor: GRANULES INDIA LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE	DIPHENHYDRAMINE HYDROCHLORIDE; NAPROXEN SODIUM	TABLET;ORAL	25MG;220MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A213663-001	NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE	DIPHENHYDRAMINE HYDROCHLORIDE; NAPROXEN SODIUM	25MG;220MG	TABLET / ORAL			2020-09-24

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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A213663-001	NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;220MG	TABLET / ORAL	2020-09-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A213663-001	NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;220MG	TABLET / ORAL	2020-09-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213663-001	NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;220MG	TABLET / ORAL	2020-09-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213663-001	NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;220MG	TABLET / ORAL	2020-09-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213663-001	NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;220MG	TABLET / ORAL	2020-09-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213663-001	NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;220MG	TABLET / ORAL	2020-09-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213663-001	NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;220MG	TABLET / ORAL	2020-09-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213663-001	NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;220MG	TABLET / ORAL	2020-09-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213663-001	NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;220MG	TABLET / ORAL	2020-09-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213663-001	NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;220MG	TABLET / ORAL	2020-09-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213663-001	NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;220MG	TABLET / ORAL	2020-09-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213663-001	NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;220MG	TABLET / ORAL	2020-09-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213663-001	NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;220MG	TABLET / ORAL	2020-09-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213663-001	NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;220MG	TABLET / ORAL	2020-09-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213663-001	NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;220MG	TABLET / ORAL	2020-09-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213663-001	NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;220MG	TABLET / ORAL	2020-09-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A213663-001	NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;220MG	TABLET / ORAL	2020-09-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A213663-001	NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;220MG	TABLET / ORAL	2020-09-24	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A213663-001	NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;220MG	TABLET / ORAL	2020-09-24	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A213663-001	NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;220MG	TABLET / ORAL	2020-09-24	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A213663-001	NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;220MG	TABLET / ORAL	2020-09-24	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A213663-001	NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;220MG	TABLET / ORAL	2020-09-24	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A213663-001	NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;220MG	TABLET / ORAL	2020-09-24	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A213663-001	NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;220MG	TABLET / ORAL	2020-09-24	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A213663-001	NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;220MG	TABLET / ORAL	2020-09-24	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A213663-001	NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;220MG	TABLET / ORAL	2020-09-24	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A213663-001	NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;220MG	TABLET / ORAL	2020-09-24	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A213663-001	NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;220MG	TABLET / ORAL	2020-09-24	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A213663-001	NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;220MG	TABLET / ORAL	2020-09-24	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A213663-001	NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;220MG	TABLET / ORAL	2020-09-24	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A213663-001	NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;220MG	TABLET / ORAL	2020-09-24	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A213663-001	NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;220MG	TABLET / ORAL	2020-09-24	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A213663-001	NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;220MG	TABLET / ORAL	2020-09-24	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A213663-001	NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;220MG	TABLET / ORAL	2020-09-24	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A213663-001	NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;220MG	TABLET / ORAL	2020-09-24	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A213663-001	NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;220MG	TABLET / ORAL	2020-09-24	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A213663-001	NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;220MG	TABLET / ORAL	2020-09-24	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A213663-001	NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE	25MG;220MG	TABLET / ORAL	2020-09-24	`a50c72e98297…`

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Naproxen Sodium Diphenhydramine HCL	NAPROXEN SODIUM DIPHENHYDRAMINE HCL	Walmart	fe810c0e-ab42-5a8a-e053-6394a90affe4	2025-12-19	Warnings	Exact identifier application applno (ANDA): 213663 application number: ANDA213663
Naproxen Sodium and Diphenhydramine HCL	NAPROXEN SODIUM AND DIPHENHYDRAMINE HCL	TARGET CORPORATION	fe82699d-fdc2-038e-e053-6294a90a606c	2025-12-19	Warnings	Exact identifier application applno (ANDA): 213663 application number: ANDA213663
Naproxen Sodium Diphenhydramine HCl	NAPROXEN SODIUM DIPHENHYDRAMINE HCL	CVS PHARMACY, INC	bdac694e-ab2a-376d-e053-2a95a90a9467	2025-12-19	Warnings	Exact identifier application applno (ANDA): 213663 application number: ANDA213663 ndc (product): 69842-328
Naproxen Sodium Diphenhydramine Hydrochloride	NAPROXEN SODIUM DIPHENHYDRAMINE HYDROCHLORIDE	SAFEWAY	ed0f3275-f156-13a3-e053-2a95a90a2ce8	2025-12-18	Warnings	Exact identifier application applno (ANDA): 213663 application number: ANDA213663
Naproxen Sodium and Diphenhydramine HCl	NAPROXEN SODIUM AND DIPHENHYDRAMINE HCL	Granules India Ltd	0d59780a-ef22-4b67-8b42-9795dbec8db0	2025-08-01	Warnings	Exact identifier application applno (ANDA): 213663 application number: ANDA213663 ndc (product): 62207-814

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0363-9766	Naproxen Sodium Diphenhydramine HCl	Naproxen Sodium Diphenhydramine HCl	WALGREEN CO.	ANDA	Current
62207-814	Naproxen Sodium and Diphenhydramine HCl	Naproxen Sodium and Diphenhydramine HCl	Granules India Ltd	ANDA	Current
62207-814	Naproxen Sodium and Diphenhydramine HCl	Naproxen Sodium and Diphenhydramine HCl	Granules India Ltd	ANDA	Current
62207-814	Naproxen Sodium and Diphenhydramine HCl	Naproxen Sodium and Diphenhydramine HCl	Granules India Ltd	ANDA	Current
69842-328	Naproxen Sodium Diphenhydramine HCl	Naproxen Sodium Diphenhydramine HCl	CVS PHARMACY, INC	ANDA	Current