Application 214731

Type: ANDA
Sponsor: NOVAST LABS LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	MEMANTINE HYDROCHLORIDE	MEMANTINE HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	7MG	No	No
002	MEMANTINE HYDROCHLORIDE	MEMANTINE HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	14MG	No	No
003	MEMANTINE HYDROCHLORIDE	MEMANTINE HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	21MG	No	No
004	MEMANTINE HYDROCHLORIDE	MEMANTINE HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	28MG	No	No

Source provenance: Browse the complete Orange Book source catalog.

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