Application 090961

Type: ANDA
Sponsor: CADILA

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
A090961-001	MEMANTINE HYDROCHLORIDE	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2017-07-10
A090961-002	MEMANTINE HYDROCHLORIDE	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB		2017-07-10

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A090961-001	AB
A090961-002	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-01 22:54:32	2026-06	A090961-001	MEMANTINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2017-07-10	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A090961-002	MEMANTINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB		2017-07-10	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-01 22:54:32	2026-06	A090961-001	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A090961-002	AB	1	`a50c72e98297…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 16 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Memantine Hydrochloride	MEMANTINE HYDROCHLORIDE	REMEDYREPACK INC.	cbfd9d95-f50b-45ff-9857-9f1712c45e56	2026-04-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090961 application number: ANDA090961 ndc (product): 70518-3338
MEMANTINE HYDROCHLORIDE	MEMANTINE HYDROCHLORIDE	DirectRx	d0839a2d-35f1-1f14-e053-2995a90ad549	2026-03-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090961 application number: ANDA090961 ndc (product): 72189-294
Memantine Hydrochloride	MEMANTINE HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	3662b11a-354a-b683-e063-6394a90a0086	2025-05-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090961 application number: ANDA090961
Memantine Hydrochloride	MEMANTINE HYDROCHLORIDE	Coupler LLC	2d54be77-75b2-76b3-e063-6294a90a0cc0	2025-02-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090961 application number: ANDA090961
Memantine Hydrochloride	MEMANTINE HYDROCHLORIDE	Zydus Lifesciences Limited	514421f3-f525-43e8-aecc-8b2bbffd00dc	2024-08-16		Exact identifier application applno (ANDA): 090961 application number: ANDA090961 ndc (product): 70771-1120 ndc (product): 70771-1119
Memantine Hydrochloride	MEMANTINE HYDROCHLORIDE	A-S Medication Solutions	f05e381f-850d-42ea-9dd8-6d1f8dac4f62	2024-05-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090961 application number: ANDA090961 ndc (product): 50090-6291
Memantine Hydrochloride	MEMANTINE HYDROCHLORIDE	Bryant Ranch Prepack	0ad2246a-ffa0-43a0-8094-58279d3e3a74	2024-02-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090961 application number: ANDA090961
Memantine Hydrochloride	MEMANTINE HYDROCHLORIDE	Bryant Ranch Prepack	be919d34-e9f4-49c8-8145-2dcafb7cb88c	2024-02-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090961 application number: ANDA090961
Memantine Hydrochloride	MEMANTINE HYDROCHLORIDE	Bryant Ranch Prepack	9cfddd01-6e1d-4ee0-9310-3fb371724e3d	2023-10-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090961 application number: ANDA090961 ndc (product): 71335-1732
Memantine Hydrochloride	MEMANTINE HYDROCHLORIDE	Bryant Ranch Prepack	bf395152-2885-4633-bf3f-2da46e7b79f1	2023-03-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090961 application number: ANDA090961 ndc (product): 71335-1603
Memantine Hydrochloride	MEMANTINE HYDROCHLORIDE	Bryant Ranch Prepack	8bd5b908-f46a-4ced-9408-45984d716149	2023-03-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090961 application number: ANDA090961 ndc (product): 71335-2013
Memantine Hydrochloride	MEMANTINE HYDROCHLORIDE	Bryant Ranch Prepack	2bd37a6f-bdeb-42c2-9f03-fbf06b45cfe0	2023-03-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090961 application number: ANDA090961 ndc (product): 63629-2513
Memantine Hydrochloride	MEMANTINE HYDROCHLORIDE	Bryant Ranch Prepack	54a12ddf-306b-4eb7-a7c3-c7b58df3b372	2023-03-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090961 application number: ANDA090961 ndc (product): 63629-2511
Memantine Hydrochloride	MEMANTINE HYDROCHLORIDE	Bryant Ranch Prepack	fac8c59b-5bf5-478e-8223-a5ecaa400625	2023-03-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090961 application number: ANDA090961 ndc (product): 63629-2514
Memantine Hydrochloride	MEMANTINE HYDROCHLORIDE	Bryant Ranch Prepack	c8f96b24-de66-4a17-b798-42b42a25e84c	2023-03-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090961 application number: ANDA090961 ndc (product): 63629-2512
Memantine Hydrochloride	MEMANTINE HYDROCHLORIDE	Viona Pharmaceuticals Inc	dcbdb62a-a4e2-4058-b73c-46005f2a5d51	2022-10-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090961 application number: ANDA090961 ndc (product): 72578-004 ndc (product): 72578-003

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 36 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50090-6291	Memantine Hydrochloride	Memantine Hydrochloride	A-S Medication Solutions	ANDA	Current
63629-2511	Memantine Hydrochloride	Memantine Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-2511	Memantine Hydrochloride	Memantine Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-2512	Memantine Hydrochloride	Memantine Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-2512	Memantine Hydrochloride	Memantine Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-2513	Memantine Hydrochloride	Memantine Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-2513	Memantine Hydrochloride	Memantine Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-2514	Memantine Hydrochloride	Memantine Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-2514	Memantine Hydrochloride	Memantine Hydrochloride	Bryant Ranch Prepack	ANDA	Current
68382-388	Memantine Hydrochloride	Memantine Hydrochloride	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-389	Memantine Hydrochloride	Memantine Hydrochloride	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68788-7730	Memantine Hydrochloride	Memantine Hydrochloride	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-7730	Memantine Hydrochloride	Memantine Hydrochloride	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-7730	Memantine Hydrochloride	Memantine Hydrochloride	Preferred Pharmaceuticals, Inc.	ANDA	Current
70518-3338	Memantine Hydrochloride	Memantine Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70771-1119	Memantine Hydrochloride	Memantine Hydrochloride	Cadila Healthcare Limited	ANDA	Current
70771-1119	Memantine Hydrochloride	Memantine Hydrochloride	Cadila Healthcare Limited	ANDA	Current
70771-1119	Memantine Hydrochloride	Memantine Hydrochloride	Cadila Healthcare Limited	ANDA	Current
70771-1119	Memantine Hydrochloride	Memantine Hydrochloride	Zydus Lifesciences Limited	ANDA	Current
70771-1120	Memantine Hydrochloride	Memantine Hydrochloride	Cadila Healthcare Limited	ANDA	Current
70771-1120	Memantine Hydrochloride	Memantine Hydrochloride	Cadila Healthcare Limited	ANDA	Current
70771-1120	Memantine Hydrochloride	Memantine Hydrochloride	Cadila Healthcare Limited	ANDA	Current
70771-1120	Memantine Hydrochloride	Memantine Hydrochloride	Zydus Lifesciences Limited	ANDA	Current
71335-1603	Memantine Hydrochloride	Memantine Hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-1603	Memantine Hydrochloride	Memantine Hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-1603	Memantine Hydrochloride	Memantine Hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-1732	Memantine Hydrochloride	Memantine Hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-1732	Memantine Hydrochloride	Memantine Hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-2013	Memantine Hydrochloride	Memantine Hydrochloride	Bryant Ranch Prepack	ANDA	Current
72189-294	MEMANTINE HYDROCHLORIDE	MEMANTINE HYDROCHLORIDE	DirectRx	ANDA	Current
72578-003	Memantine Hydrochloride	Memantine Hydrochloride	Viona Pharmaceuticals Inc	ANDA	Current
72578-003	Memantine Hydrochloride	Memantine Hydrochloride	Viona Pharmaceuticals Inc	ANDA	Current
72578-003	Memantine Hydrochloride	Memantine Hydrochloride	Viona Pharmaceuticals Inc	ANDA	Current
72578-004	Memantine Hydrochloride	Memantine Hydrochloride	Viona Pharmaceuticals Inc	ANDA	Current
72578-004	Memantine Hydrochloride	Memantine Hydrochloride	Viona Pharmaceuticals Inc	ANDA	Current
72578-004	Memantine Hydrochloride	Memantine Hydrochloride	Viona Pharmaceuticals Inc	ANDA	Current