Application 090073

Type: ANDA
Sponsor: CELLTRION

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	MEMANTINE HYDROCHLORIDE	MEMANTINE HYDROCHLORIDE	TABLET;ORAL	5MG	No	No
002	MEMANTINE HYDROCHLORIDE	MEMANTINE HYDROCHLORIDE	TABLET;ORAL	10MG	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
A090073-001	MEMANTINE HYDROCHLORIDE	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL			2015-09-04
A090073-002	MEMANTINE HYDROCHLORIDE	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL			2015-09-04

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 3 · 82 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	A090073-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL		2015-09-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090073-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL		2015-09-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090073-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL		2015-09-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090073-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL		2015-09-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090073-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL		2015-09-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090073-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL		2015-09-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090073-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL		2015-09-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090073-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL		2015-09-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090073-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL		2015-09-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090073-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL		2015-09-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090073-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL		2015-09-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090073-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL		2015-09-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090073-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL		2015-09-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090073-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL		2015-09-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090073-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-09-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090073-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-09-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090073-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-09-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090073-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-09-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090073-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-09-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090073-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-09-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090073-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-09-04	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090073-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-09-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090073-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-09-04	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090073-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-09-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090073-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-09-04	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090073-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-09-04	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090073-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-09-04	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A090073-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-09-04	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090073-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-09-04	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090073-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-09-04	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090073-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-09-04	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090073-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-09-04	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090073-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-09-04	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090073-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-09-04	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090073-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-09-04	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090073-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-09-04	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090073-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-09-04	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A090073-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-09-04	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090073-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2015-09-04	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A090073-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2015-09-04	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 66 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090073-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090073-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090073-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090073-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090073-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090073-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090073-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090073-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090073-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090073-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090073-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090073-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090073-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A090073-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090073-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090073-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090073-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090073-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090073-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090073-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090073-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090073-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090073-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A090073-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090073-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A090073-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090073-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090073-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090073-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A090073-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090073-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A090073-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090073-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A090073-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090073-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A090073-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090073-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A090073-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090073-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A090073-002	AB	1	`ea99ee380514…`

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 4 · 63 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Memantine Hydrochloride	MEMANTINE HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	becb09dc-174d-4817-88d4-f38c8adcd309	2026-06-17	Warnings, Adverse reactions	Name fallback brand name: Memantine Hydrochloride generic name: MEMANTINE HYDROCHLORIDE
Memantine Hydrochloride	MEMANTINE HYDROCHLORIDE	Major Pharmaceuticals	d0a5e0fc-04e3-417d-bef3-9b309ff71597	2026-06-09	Warnings, Adverse reactions	Name fallback brand name: Memantine Hydrochloride generic name: MEMANTINE HYDROCHLORIDE
memantine hydrochloride	MEMANTINE HYDROCHLORIDE	Cardinal Health 107, LLC	e5754973-e73b-4a25-abb4-80f91880f018	2026-06-05	Warnings, Adverse reactions	Name fallback brand name: memantine hydrochloride generic name: MEMANTINE HYDROCHLORIDE
Memantine Hydrochloride	MEMANTINE HYDROCHLORIDE	Bryant Ranch Prepack	afc07196-be28-4521-afc0-d4aa5b6fd46d	2026-05-20	Warnings, Adverse reactions	Name fallback brand name: Memantine Hydrochloride generic name: MEMANTINE HYDROCHLORIDE
Memantine Hydrochloride	MEMANTINE HYDROCHLORIDE	Slate Run Pharmaceuticals, LLC	a74050c4-5a37-4fa1-85d9-85831525cfeb	2026-04-21	Warnings, Adverse reactions	Name fallback brand name: Memantine Hydrochloride generic name: MEMANTINE HYDROCHLORIDE
Memantine Hydrochloride	MEMANTINE HYDROCHLORIDE	REMEDYREPACK INC.	cbfd9d95-f50b-45ff-9857-9f1712c45e56	2026-04-08	Warnings, Adverse reactions	Name fallback brand name: Memantine Hydrochloride generic name: MEMANTINE HYDROCHLORIDE
MEMANTINE HYDROCHLORIDE	MEMANTINE HYDROCHLORIDE	DirectRx	d0839a2d-35f1-1f14-e053-2995a90ad549	2026-03-06	Warnings, Adverse reactions	Name fallback brand name: MEMANTINE HYDROCHLORIDE generic name: MEMANTINE HYDROCHLORIDE
Memantine Hydrochloride	MEMANTINE HYDROCHLORIDE ORAL	Seton Pharmaceuticals	421f6478-09df-49d3-a7c4-52814b4aa90e	2026-02-27	Warnings, Adverse reactions	Name fallback brand name: Memantine Hydrochloride
Memantine Hydrochloride	MEMANTINE HYDROCHLORIDE	Chartwell Governmental & Specialty RX, LLC.	d1f97615-e888-421e-b50a-95a87a1965ff	2026-02-06	Warnings, Adverse reactions	Name fallback brand name: Memantine Hydrochloride generic name: MEMANTINE HYDROCHLORIDE
Memantine Hydrochloride	MEMANTINE HYDROCHLORIDE	Chartwell RX, LLC	a7b76864-6de7-45f6-be5b-5ecfca811627	2026-01-30	Warnings, Adverse reactions	Name fallback brand name: Memantine Hydrochloride generic name: MEMANTINE HYDROCHLORIDE
Memantine Hydrochloride	MEMANTINE HYDROCHLORIDE	Cardinal Health 107, LLC	65c9e7bc-71f0-4113-8de1-4fcaa591735f	2026-01-15	Warnings, Adverse reactions	Name fallback brand name: Memantine Hydrochloride generic name: MEMANTINE HYDROCHLORIDE
memantine hydrochloride	MEMANTINE HYDROCHLORIDE	Lupin Pharmaceuticals, Inc.	24290655-47f3-4042-a977-a832c5161d2c	2026-01-15	Warnings, Adverse reactions	Name fallback brand name: memantine hydrochloride generic name: MEMANTINE HYDROCHLORIDE
Memantine Hydrochloride	MEMANTINE HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	47e4a696-fe2a-c905-e063-6294a90a7415	2026-01-08	Warnings, Adverse reactions	Name fallback brand name: Memantine Hydrochloride generic name: MEMANTINE HYDROCHLORIDE
Memantine Hydrochloride	MEMANTINE HYDROCHLORIDE	AvPAK	11d27c75-fdc0-f9da-e063-6394a90ac6b0	2026-01-08	Warnings, Adverse reactions	Name fallback brand name: Memantine Hydrochloride generic name: MEMANTINE HYDROCHLORIDE
memantine hydrochloride	MEMANTINE HYDROCHLORIDE	Major Pharmaceuticals	f6ce7cca-d245-44f2-986c-2a8d85dbb5fb	2026-01-07	Warnings, Adverse reactions	Name fallback brand name: memantine hydrochloride generic name: MEMANTINE HYDROCHLORIDE
Memantine hydrochloride	MEMANTINE HYDROCHLORIDE	Lupin Pharmaceuticals, Inc.	1b4a0162-9cb4-4ba6-8c02-95c2955734ae	2025-12-29	Warnings, Adverse reactions	Name fallback brand name: Memantine hydrochloride generic name: MEMANTINE HYDROCHLORIDE
memantine hydrochloride	MEMANTINE	Amneal Pharmaceuticals LLC	f73e0df0-4af4-42f1-bde6-3cccb47ca378	2025-12-20	Warnings, Adverse reactions	Name fallback brand name: memantine hydrochloride
Memantine Hydrochloride	MEMANTINE HYDROCHLORIDE	Upsher-Smith Laboratories, LLC	6e0ade9e-b721-4701-bcb7-de464e19e707	2025-12-11	Warnings, Adverse reactions	Name fallback brand name: Memantine Hydrochloride generic name: MEMANTINE HYDROCHLORIDE
Memantine Hydrochloride	MEMANTINE HYDROCHLORIDE	Ajanta Pharma USA Inc.	292671f2-f221-4a3d-a110-a266a9527e04	2025-11-27	Warnings, Adverse reactions	Name fallback brand name: Memantine Hydrochloride generic name: MEMANTINE HYDROCHLORIDE
Memantine hydrochloride	MEMANTINE HYDROCHLORIDE	Macleods Pharmaceuticals Limited	62e32b0b-1eb2-424d-bfd2-d27ef27d35f3	2025-10-14	Warnings, Adverse reactions	Name fallback brand name: Memantine hydrochloride generic name: MEMANTINE HYDROCHLORIDE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 10 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
62980-121	Memantine Hydrochloride	Memantine Hydrochloride	Vivimed Labs Limited	ANDA	Current
62980-122	Memantine Hydrochloride	Memantine Hydrochloride	Vivimed Labs Limited	ANDA	Current
62980-123	Memantine Hydrochloride	Memantine Hydrochloride	Vivimed Labs Limited	ANDA	Current
64679-121	Memantine Hydrochloride	Memantine Hydrochloride	Wockhardt USA LLC.	ANDA	Current
64679-122	Memantine Hydrochloride	Memantine Hydrochloride	Wockhardt USA LLC.	ANDA	Current
64679-123	Memantine Hydrochloride	Memantine Hydrochloride	Wockhardt USA LLC.	ANDA	Current
71335-1798	Memantine Hydrochloride	Memantine Hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-1863	Memantine Hydrochloride	Memantine Hydrochloride	Bryant Ranch Prepack	ANDA	Current
72606-514	Memantine Hydrochloride	Memantine Hydrochloride	CELLTRION USA, INC.	ANDA	Current
72606-515	Memantine Hydrochloride	Memantine Hydrochloride	CELLTRION USA, INC.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
31448	ORIG	2016-02-18