Application 210319

Type: ANDA
Sponsor: MEDLEY PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	MEMANTINE HYDROCHLORIDE	MEMANTINE HYDROCHLORIDE	SOLUTION;ORAL	2MG/ML	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
A210319-001	MEMANTINE HYDROCHLORIDE	MEMANTINE HYDROCHLORIDE	2MG/ML	SOLUTION / ORAL	AA		2020-08-31

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A210319-001	AA

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	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A210319-001	MEMANTINE HYDROCHLORIDE	2MG/ML	SOLUTION / ORAL	AA	2020-08-31	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210319-001	MEMANTINE HYDROCHLORIDE	2MG/ML	SOLUTION / ORAL	AA	2020-08-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210319-001	MEMANTINE HYDROCHLORIDE	2MG/ML	SOLUTION / ORAL	AA	2020-08-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210319-001	MEMANTINE HYDROCHLORIDE	2MG/ML	SOLUTION / ORAL	AA	2020-08-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210319-001	MEMANTINE HYDROCHLORIDE	2MG/ML	SOLUTION / ORAL	AA	2020-08-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210319-001	MEMANTINE HYDROCHLORIDE	2MG/ML	SOLUTION / ORAL	AA	2020-08-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210319-001	MEMANTINE HYDROCHLORIDE	2MG/ML	SOLUTION / ORAL	AA	2020-08-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210319-001	MEMANTINE HYDROCHLORIDE	2MG/ML	SOLUTION / ORAL	AA	2020-08-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210319-001	MEMANTINE HYDROCHLORIDE	2MG/ML	SOLUTION / ORAL	AA	2020-08-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210319-001	MEMANTINE HYDROCHLORIDE	2MG/ML	SOLUTION / ORAL	AA	2020-08-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210319-001	MEMANTINE HYDROCHLORIDE	2MG/ML	SOLUTION / ORAL	AA	2020-08-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210319-001	MEMANTINE HYDROCHLORIDE	2MG/ML	SOLUTION / ORAL	AA	2020-08-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210319-001	MEMANTINE HYDROCHLORIDE	2MG/ML	SOLUTION / ORAL	AA	2020-08-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210319-001	MEMANTINE HYDROCHLORIDE	2MG/ML	SOLUTION / ORAL	AA	2020-08-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210319-001	MEMANTINE HYDROCHLORIDE	2MG/ML	SOLUTION / ORAL	AA	2020-08-31	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210319-001	MEMANTINE HYDROCHLORIDE	2MG/ML	SOLUTION / ORAL	AA	2020-08-31	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210319-001	MEMANTINE HYDROCHLORIDE	2MG/ML	SOLUTION / ORAL	AA	2020-08-31	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210319-001	MEMANTINE HYDROCHLORIDE	2MG/ML	SOLUTION / ORAL	AA	2020-08-31	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A210319-001	MEMANTINE HYDROCHLORIDE	2MG/ML	SOLUTION / ORAL	AA	2020-08-31	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210319-001	MEMANTINE HYDROCHLORIDE	2MG/ML	SOLUTION / ORAL	AA	2020-08-31	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210319-001	MEMANTINE HYDROCHLORIDE	2MG/ML	SOLUTION / ORAL	AA	2020-08-31	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A210319-001	MEMANTINE HYDROCHLORIDE	2MG/ML	SOLUTION / ORAL	AA	2020-08-31	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A210319-001	MEMANTINE HYDROCHLORIDE	2MG/ML	SOLUTION / ORAL	AA	2020-08-31	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A210319-001	MEMANTINE HYDROCHLORIDE	2MG/ML	SOLUTION / ORAL	AA	2020-08-31	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210319-001	MEMANTINE HYDROCHLORIDE	2MG/ML	SOLUTION / ORAL	AA	2020-08-31	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A210319-001	MEMANTINE HYDROCHLORIDE	2MG/ML	SOLUTION / ORAL	AA	2020-08-31	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A210319-001	MEMANTINE HYDROCHLORIDE	2MG/ML	SOLUTION / ORAL	AA	2020-08-31	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A210319-001	MEMANTINE HYDROCHLORIDE	2MG/ML	SOLUTION / ORAL	AA	2020-08-31	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A210319-001	MEMANTINE HYDROCHLORIDE	2MG/ML	SOLUTION / ORAL	AA	2020-08-31	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A210319-001	MEMANTINE HYDROCHLORIDE	2MG/ML	SOLUTION / ORAL	AA	2020-08-31	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A210319-001	MEMANTINE HYDROCHLORIDE	2MG/ML	SOLUTION / ORAL	AA	2020-08-31	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A210319-001	MEMANTINE HYDROCHLORIDE	2MG/ML	SOLUTION / ORAL	AA	2020-08-31	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A210319-001	MEMANTINE HYDROCHLORIDE	2MG/ML	SOLUTION / ORAL	AA	2020-08-31	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A210319-001	MEMANTINE HYDROCHLORIDE	2MG/ML	SOLUTION / ORAL	AA	2020-08-31	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A210319-001	MEMANTINE HYDROCHLORIDE	2MG/ML	SOLUTION / ORAL	AA	2020-08-31	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A210319-001	MEMANTINE HYDROCHLORIDE	2MG/ML	SOLUTION / ORAL	AA	2020-08-31	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A210319-001	MEMANTINE HYDROCHLORIDE	2MG/ML	SOLUTION / ORAL	AA	2020-08-31	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A210319-001	MEMANTINE HYDROCHLORIDE	2MG/ML	SOLUTION / ORAL	AA	2020-08-31	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A210319-001	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210319-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210319-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210319-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210319-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210319-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210319-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210319-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210319-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210319-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210319-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210319-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210319-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210319-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210319-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210319-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210319-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210319-001	AA	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A210319-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210319-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210319-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A210319-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A210319-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A210319-001	AA	1	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210319-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A210319-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A210319-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A210319-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A210319-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A210319-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A210319-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A210319-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A210319-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A210319-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A210319-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A210319-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A210319-001	AA	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A210319-001	AA	1	`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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Memantine Hydrochloride	MEMANTINE HYDROCHLORIDE ORAL	Seton Pharmaceuticals	421f6478-09df-49d3-a7c4-52814b4aa90e	2026-02-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210319 application number: ANDA210319 ndc (product): 13925-540

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
13925-540	Memantine Hydrochloride	Memantine Hydrochloride Oral	Seton Pharmaceuticals	ANDA	Current
42934-300	Memantine Hydrochloride	Memantine Hydrochloride Oral	Medley Pharmaceuticals Limited	ANDA	Current