Application 220386

Type: ANDA
Sponsor: REGCON HOLDINGS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LACOSAMIDE	LACOSAMIDE	SOLUTION;ORAL	10MG/ML	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A220386-001	LACOSAMIDE	LACOSAMIDE	10MG/ML	SOLUTION / ORAL	AA		2026-01-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A220386-001	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
2026-10-15 13:18:30	2026-09	A220386-001	LACOSAMIDE	10MG/ML	SOLUTION / ORAL	AA	2026-01-29	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A220386-001	LACOSAMIDE	10MG/ML	SOLUTION / ORAL	AA	2026-01-29	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A220386-001	LACOSAMIDE	10MG/ML	SOLUTION / ORAL	AA	2026-01-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A220386-001	LACOSAMIDE	10MG/ML	SOLUTION / ORAL	AA	2026-01-29	`011fe1cb6892…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A220386-001	LACOSAMIDE	10MG/ML	SOLUTION / ORAL	AA	2026-01-29	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	A220386-001	AA	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A220386-001	AA	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A220386-001	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A220386-001	AA	1	`011fe1cb6892…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A220386-001	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 4 of 4 · 64 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lacosamide	LACOSAMIDE	Alembic Pharmaceuticals Limited	46b98d5e-fdb6-483a-b022-8b1f0aa832c5	2023-01-27	Warnings, Adverse reactions	Name fallback brand name: Lacosamide generic name: LACOSAMIDE
LACOSAMIDE	LACOSAMIDE	XLCare Pharmaceuticals Inc.	c7793da3-787b-4364-9192-7caab49066f1	2023-01-27	Warnings, Adverse reactions	Name fallback brand name: LACOSAMIDE generic name: LACOSAMIDE
lacosamide	LACOSAMIDE	MSN LABORATORIES PRIVATE LIMITED	0ae4e2d1-305d-4045-95da-cfe7c2d8b435	2022-04-21		Name fallback brand name: lacosamide generic name: LACOSAMIDE
Lacosamide	LACOSAMIDE	Indoco Remedies Limited	145b4fae-ce6d-43e8-a474-fcb9dff92a53	2022-03-09	Warnings, Adverse reactions	Name fallback brand name: Lacosamide generic name: LACOSAMIDE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.