Application 204921

Type: ANDA
Sponsor: MSN LABS PVT LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LACOSAMIDE	LACOSAMIDE	TABLET;ORAL	50MG	No	No
002	LACOSAMIDE	LACOSAMIDE	TABLET;ORAL	100MG	No	No
003	LACOSAMIDE	LACOSAMIDE	TABLET;ORAL	150MG	No	No
004	LACOSAMIDE	LACOSAMIDE	TABLET;ORAL	200MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A204921-001	LACOSAMIDE	LACOSAMIDE	50MG	TABLET / ORAL	AB	2022-03-17
A204921-002	LACOSAMIDE	LACOSAMIDE	100MG	TABLET / ORAL	AB	2022-03-17
A204921-003	LACOSAMIDE	LACOSAMIDE	150MG	TABLET / ORAL	AB	2022-03-17
A204921-004	LACOSAMIDE	LACOSAMIDE	200MG	TABLET / ORAL	AB	2022-03-17

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
A204921-001	AB
A204921-002	AB
A204921-003	AB
A204921-004	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.

Product history page 1 of 3 · 120 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	A204921-001	LACOSAMIDE	50MG	TABLET / ORAL	AB	2022-03-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204921-002	LACOSAMIDE	100MG	TABLET / ORAL	AB	2022-03-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204921-003	LACOSAMIDE	150MG	TABLET / ORAL	AB	2022-03-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204921-004	LACOSAMIDE	200MG	TABLET / ORAL	AB	2022-03-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204921-001	LACOSAMIDE	50MG	TABLET / ORAL	AB	2022-03-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204921-002	LACOSAMIDE	100MG	TABLET / ORAL	AB	2022-03-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204921-003	LACOSAMIDE	150MG	TABLET / ORAL	AB	2022-03-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204921-004	LACOSAMIDE	200MG	TABLET / ORAL	AB	2022-03-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204921-001	LACOSAMIDE	50MG	TABLET / ORAL	AB	2022-03-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204921-002	LACOSAMIDE	100MG	TABLET / ORAL	AB	2022-03-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204921-003	LACOSAMIDE	150MG	TABLET / ORAL	AB	2022-03-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204921-004	LACOSAMIDE	200MG	TABLET / ORAL	AB	2022-03-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204921-001	LACOSAMIDE	50MG	TABLET / ORAL	AB	2022-03-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204921-002	LACOSAMIDE	100MG	TABLET / ORAL	AB	2022-03-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204921-003	LACOSAMIDE	150MG	TABLET / ORAL	AB	2022-03-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204921-004	LACOSAMIDE	200MG	TABLET / ORAL	AB	2022-03-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204921-001	LACOSAMIDE	50MG	TABLET / ORAL	AB	2022-03-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204921-002	LACOSAMIDE	100MG	TABLET / ORAL	AB	2022-03-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204921-003	LACOSAMIDE	150MG	TABLET / ORAL	AB	2022-03-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204921-004	LACOSAMIDE	200MG	TABLET / ORAL	AB	2022-03-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204921-001	LACOSAMIDE	50MG	TABLET / ORAL	AB	2022-03-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204921-002	LACOSAMIDE	100MG	TABLET / ORAL	AB	2022-03-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204921-003	LACOSAMIDE	150MG	TABLET / ORAL	AB	2022-03-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204921-004	LACOSAMIDE	200MG	TABLET / ORAL	AB	2022-03-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204921-001	LACOSAMIDE	50MG	TABLET / ORAL	AB	2022-03-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204921-002	LACOSAMIDE	100MG	TABLET / ORAL	AB	2022-03-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204921-003	LACOSAMIDE	150MG	TABLET / ORAL	AB	2022-03-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204921-004	LACOSAMIDE	200MG	TABLET / ORAL	AB	2022-03-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204921-001	LACOSAMIDE	50MG	TABLET / ORAL	AB	2022-03-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204921-002	LACOSAMIDE	100MG	TABLET / ORAL	AB	2022-03-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204921-003	LACOSAMIDE	150MG	TABLET / ORAL	AB	2022-03-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204921-004	LACOSAMIDE	200MG	TABLET / ORAL	AB	2022-03-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204921-001	LACOSAMIDE	50MG	TABLET / ORAL	AB	2022-03-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204921-002	LACOSAMIDE	100MG	TABLET / ORAL	AB	2022-03-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204921-003	LACOSAMIDE	150MG	TABLET / ORAL	AB	2022-03-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204921-004	LACOSAMIDE	200MG	TABLET / ORAL	AB	2022-03-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204921-001	LACOSAMIDE	50MG	TABLET / ORAL	AB	2022-03-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204921-002	LACOSAMIDE	100MG	TABLET / ORAL	AB	2022-03-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204921-003	LACOSAMIDE	150MG	TABLET / ORAL	AB	2022-03-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204921-004	LACOSAMIDE	200MG	TABLET / ORAL	AB	2022-03-17	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 120 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A204921-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204921-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204921-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204921-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204921-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204921-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204921-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204921-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204921-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204921-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204921-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204921-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204921-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204921-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204921-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204921-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204921-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204921-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204921-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204921-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204921-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204921-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204921-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204921-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204921-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204921-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204921-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204921-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204921-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204921-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204921-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204921-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204921-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204921-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204921-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204921-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204921-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204921-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204921-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204921-004	AB	1	`d06236e962d9…`

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
LACOSAMIDE	LACOSAMIDE	Golden State Medical Supply, Inc.	f047077c-2ac7-30d0-e053-2995a90ae429	2025-01-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204921 application number: ANDA204921 ndc (product): 51407-723 ndc (product): 51407-722 ndc (product): 51407-724 ndc (product): 51407-721
LACOSAMIDE	LACOSAMIDE	Breckenridge Pharmaceutical, Inc.	f7ea3ce6-4ca7-4405-a011-48e7d71360a5	2024-09-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204921 application number: ANDA204921 ndc (product): 51991-351 ndc (product): 51991-348 ndc (product): 51991-349 ndc (product): 51991-350
lacosamide	LACOSAMIDE	MSN LABORATORIES PRIVATE LIMITED	0ae4e2d1-305d-4045-95da-cfe7c2d8b435	2022-04-21		Exact identifier application applno (ANDA): 204921 application number: ANDA204921 ndc (product): 69539-027 ndc (product): 69539-028 ndc (product): 69539-026 ndc (product): 69539-025

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 28 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
51407-721	LACOSAMIDE	LACOSAMIDE	Golden State Medical Supply, Inc.	ANDA	Current
51407-722	LACOSAMIDE	LACOSAMIDE	Golden State Medical Supply, Inc.	ANDA	Current
51407-723	LACOSAMIDE	LACOSAMIDE	Golden State Medical Supply, Inc.	ANDA	Current
51407-724	LACOSAMIDE	LACOSAMIDE	Golden State Medical Supply, Inc.	ANDA	Current
51991-348	LACOSAMIDE	LACOSAMIDE	Breckenridge Pharmaceutical, Inc.	ANDA	Current
51991-348	LACOSAMIDE	LACOSAMIDE	Breckenridge Pharmaceutical, Inc.	ANDA	Current
51991-348	LACOSAMIDE	LACOSAMIDE	Breckenridge Pharmaceutical, Inc.	ANDA	Current
51991-349	LACOSAMIDE	LACOSAMIDE	Breckenridge Pharmaceutical, Inc.	ANDA	Current
51991-349	LACOSAMIDE	LACOSAMIDE	Breckenridge Pharmaceutical, Inc.	ANDA	Current
51991-349	LACOSAMIDE	LACOSAMIDE	Breckenridge Pharmaceutical, Inc.	ANDA	Current
51991-350	LACOSAMIDE	LACOSAMIDE	Breckenridge Pharmaceutical, Inc.	ANDA	Current
51991-350	LACOSAMIDE	LACOSAMIDE	Breckenridge Pharmaceutical, Inc.	ANDA	Current
51991-350	LACOSAMIDE	LACOSAMIDE	Breckenridge Pharmaceutical, Inc.	ANDA	Current
51991-351	LACOSAMIDE	LACOSAMIDE	Breckenridge Pharmaceutical, Inc.	ANDA	Current
51991-351	LACOSAMIDE	LACOSAMIDE	Breckenridge Pharmaceutical, Inc.	ANDA	Current
51991-351	LACOSAMIDE	LACOSAMIDE	Breckenridge Pharmaceutical, Inc.	ANDA	Current
63850-0053	Lacosamide	Lacosamide	Natco Pharma Limited	ANDA	Current
63850-0054	Lacosamide	Lacosamide	Natco Pharma Limited	ANDA	Current
63850-0055	Lacosamide	Lacosamide	Natco Pharma Limited	ANDA	Current
63850-0056	Lacosamide	Lacosamide	Natco Pharma Limited	ANDA	Current
69539-025	lacosamide	lacosamide	MSN LABORATORIES PRIVATE LIMITED	ANDA	Current
69539-025	lacosamide	lacosamide	MSN LABORATORIES PRIVATE LIMITED	ANDA	Current
69539-026	lacosamide	lacosamide	MSN LABORATORIES PRIVATE LIMITED	ANDA	Current
69539-026	lacosamide	lacosamide	MSN LABORATORIES PRIVATE LIMITED	ANDA	Current
69539-027	lacosamide	lacosamide	MSN LABORATORIES PRIVATE LIMITED	ANDA	Current
69539-027	lacosamide	lacosamide	MSN LABORATORIES PRIVATE LIMITED	ANDA	Current
69539-028	lacosamide	lacosamide	MSN LABORATORIES PRIVATE LIMITED	ANDA	Current
69539-028	lacosamide	lacosamide	MSN LABORATORIES PRIVATE LIMITED	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
63413	ORIG	2020-06-04