Application 202543

Type: NDA
Sponsor: HQ SPECIALITY PHARMA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LEVETIRACETAM IN SODIUM CHLORIDE	LEVETIRACETAM	INJECTABLE;INTRAVENOUS	500MG/100ML (5MG/ML)	Yes	Yes
002	LEVETIRACETAM IN SODIUM CHLORIDE	LEVETIRACETAM	INJECTABLE;INTRAVENOUS	1000MG/100ML (10MG/ML)	Yes	Yes
003	LEVETIRACETAM IN SODIUM CHLORIDE	LEVETIRACETAM	INJECTABLE;INTRAVENOUS	1500MG/100ML (15MG/ML)	Yes	Yes
004	LEVETIRACETAM IN SODIUM CHLORIDE	LEVETIRACETAM	INJECTABLE;INTRAVENOUS	250MG/50ML (5MG/ML)	Yes	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	RLD / RS	Approval date
N202543-001	LEVETIRACETAM IN SODIUM CHLORIDE	LEVETIRACETAM	500MG/100ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2011-11-09
N202543-002	LEVETIRACETAM IN SODIUM CHLORIDE	LEVETIRACETAM	1GM/100ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2011-11-09
N202543-003	LEVETIRACETAM IN SODIUM CHLORIDE	LEVETIRACETAM	1.5GM/100ML (15MG/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2011-11-09
N202543-004	LEVETIRACETAM IN SODIUM CHLORIDE	LEVETIRACETAM	250MG/50ML (5MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS		RLD	2020-12-14

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
N202543-001	AP
N202543-002	AP
N202543-003	AP

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 4 · 158 observed 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
2026-02-19 14:30 UTC	2026-02	N202543-001	LEVETIRACETAM IN SODIUM CHLORIDE	500MG/100ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2011-11-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202543-002	LEVETIRACETAM IN SODIUM CHLORIDE	1GM/100ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2011-11-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202543-003	LEVETIRACETAM IN SODIUM CHLORIDE	1.5GM/100ML (15MG/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2011-11-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202543-004	LEVETIRACETAM IN SODIUM CHLORIDE	250MG/50ML (5MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS		RLD	2020-12-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202543-001	LEVETIRACETAM IN SODIUM CHLORIDE	500MG/100ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2011-11-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202543-002	LEVETIRACETAM IN SODIUM CHLORIDE	1GM/100ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2011-11-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202543-003	LEVETIRACETAM IN SODIUM CHLORIDE	1.5GM/100ML (15MG/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2011-11-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202543-004	LEVETIRACETAM IN SODIUM CHLORIDE	250MG/50ML (5MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS		RLD	2020-12-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N202543-001	LEVETIRACETAM IN SODIUM CHLORIDE	500MG/100ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2011-11-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N202543-002	LEVETIRACETAM IN SODIUM CHLORIDE	1GM/100ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2011-11-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N202543-003	LEVETIRACETAM IN SODIUM CHLORIDE	1.5GM/100ML (15MG/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2011-11-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N202543-004	LEVETIRACETAM IN SODIUM CHLORIDE	250MG/50ML (5MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS		RLD	2020-12-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202543-001	LEVETIRACETAM IN SODIUM CHLORIDE	500MG/100ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2011-11-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202543-002	LEVETIRACETAM IN SODIUM CHLORIDE	1GM/100ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2011-11-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202543-003	LEVETIRACETAM IN SODIUM CHLORIDE	1.5GM/100ML (15MG/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2011-11-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202543-004	LEVETIRACETAM IN SODIUM CHLORIDE	250MG/50ML (5MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS		RLD	2020-12-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202543-001	LEVETIRACETAM IN SODIUM CHLORIDE	500MG/100ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2011-11-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202543-002	LEVETIRACETAM IN SODIUM CHLORIDE	1GM/100ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2011-11-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202543-003	LEVETIRACETAM IN SODIUM CHLORIDE	1.5GM/100ML (15MG/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2011-11-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202543-004	LEVETIRACETAM IN SODIUM CHLORIDE	250MG/50ML (5MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS		RLD	2020-12-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202543-001	LEVETIRACETAM IN SODIUM CHLORIDE	500MG/100ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2011-11-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202543-002	LEVETIRACETAM IN SODIUM CHLORIDE	1GM/100ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2011-11-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202543-003	LEVETIRACETAM IN SODIUM CHLORIDE	1.5GM/100ML (15MG/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2011-11-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202543-004	LEVETIRACETAM IN SODIUM CHLORIDE	250MG/50ML (5MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS		RLD	2020-12-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202543-001	LEVETIRACETAM IN SODIUM CHLORIDE	500MG/100ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2011-11-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202543-002	LEVETIRACETAM IN SODIUM CHLORIDE	1GM/100ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2011-11-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202543-003	LEVETIRACETAM IN SODIUM CHLORIDE	1.5GM/100ML (15MG/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2011-11-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202543-004	LEVETIRACETAM IN SODIUM CHLORIDE	250MG/50ML (5MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS		RLD	2020-12-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202543-001	LEVETIRACETAM IN SODIUM CHLORIDE	500MG/100ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2011-11-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202543-002	LEVETIRACETAM IN SODIUM CHLORIDE	1GM/100ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2011-11-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202543-003	LEVETIRACETAM IN SODIUM CHLORIDE	1.5GM/100ML (15MG/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2011-11-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202543-004	LEVETIRACETAM IN SODIUM CHLORIDE	250MG/50ML (5MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS		RLD	2020-12-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N202543-001	LEVETIRACETAM IN SODIUM CHLORIDE	500MG/100ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2011-11-09	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N202543-002	LEVETIRACETAM IN SODIUM CHLORIDE	1GM/100ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2011-11-09	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N202543-003	LEVETIRACETAM IN SODIUM CHLORIDE	1.5GM/100ML (15MG/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2011-11-09	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N202543-004	LEVETIRACETAM IN SODIUM CHLORIDE	250MG/50ML (5MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS		RLD	2020-12-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N202543-001	LEVETIRACETAM IN SODIUM CHLORIDE	500MG/100ML (5MG/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2011-11-09	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N202543-002	LEVETIRACETAM IN SODIUM CHLORIDE	1GM/100ML (10MG/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2011-11-09	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N202543-003	LEVETIRACETAM IN SODIUM CHLORIDE	1.5GM/100ML (15MG/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2011-11-09	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N202543-004	LEVETIRACETAM IN SODIUM CHLORIDE	250MG/50ML (5MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS		RLD	2020-12-14	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 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	N202543-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202543-002	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202543-003	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202543-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202543-002	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202543-003	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N202543-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N202543-002	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N202543-003	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202543-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202543-002	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202543-003	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202543-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202543-002	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202543-003	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202543-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202543-002	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202543-003	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202543-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202543-002	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202543-003	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202543-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202543-002	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202543-003	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N202543-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N202543-002	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N202543-003	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N202543-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N202543-002	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N202543-003	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N202543-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N202543-002	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N202543-003	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N202543-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N202543-002	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N202543-003	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N202543-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N202543-002	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N202543-003	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N202543-001	AP	1	`8072bd15b7f6…`

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
Levetiracetam	LEVETIRACETAM	WG Critical Care, LLC	62f3d1c8-ca5b-4760-9fc9-41e4fb4cc926	2024-03-29	Warnings, Adverse reactions	Exact identifier application applno (NDA): 202543 application number: NDA202543 ndc (product): 44567-501 ndc (product): 44567-502 ndc (product): 44567-503
Levetiracetam	LEVETIRACETAM	Mylan Institutional LLC	70e52e89-3844-4cd9-a406-b29e9520a12c	2024-03-15	Warnings, Adverse reactions	Exact identifier application applno (NDA): 202543 application number: NDA202543 ndc (product): 67457-266 ndc (product): 67457-255 ndc (product): 67457-265
Levetiracetam	LEVETIRACETAM	WG Critical Care, LLC	5e5b0ed3-b104-45a7-bb3e-ee56febb46e8	2023-10-30	Warnings, Adverse reactions	Exact identifier application applno (NDA): 202543 application number: NDA202543 ndc (product): 44567-501 ndc (product): 44567-502

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 29 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
44567-500	Levetiracetam	Levetiracetam	WG Critical Care, LLC	NDA	Current
44567-500	Levetiracetam	Levetiracetam	WG Critical Care, LLC	NDA	Current
44567-500	Levetiracetam	Levetiracetam	WG Critical Care, LLC	NDA	Current
44567-501	Levetiracetam	Levetiracetam	WG Critical Care, LLC	NDA	Current
44567-501	Levetiracetam	Levetiracetam	WG Critical Care, LLC	NDA	Current
44567-501	Levetiracetam	Levetiracetam	WG Critical Care, LLC	NDA	Current
44567-501	Levetiracetam	Levetiracetam	WG Critical Care, LLC	NDA	Current
44567-502	Levetiracetam	Levetiracetam	WG Critical Care, LLC	NDA	Current
44567-502	Levetiracetam	Levetiracetam	WG Critical Care, LLC	NDA	Current
44567-502	Levetiracetam	Levetiracetam	WG Critical Care, LLC	NDA	Current
44567-502	Levetiracetam	Levetiracetam	WG Critical Care, LLC	NDA	Current
44567-503	Levetiracetam	Levetiracetam	WG Critical Care, LLC	NDA	Current
44567-503	Levetiracetam	Levetiracetam	WG Critical Care, LLC	NDA	Current
44567-503	Levetiracetam	Levetiracetam	WG Critical Care, LLC	NDA	Current
67457-255	Levetiracetam	Levetiracetam	Mylan Institutional LLC	NDA	Current
67457-255	Levetiracetam	Levetiracetam	Mylan Institutional LLC	NDA	Current
67457-255	Levetiracetam	Levetiracetam	Mylan Institutional LLC	NDA	Current
67457-255	Levetiracetam	Levetiracetam	Mylan Institutional LLC	NDA	Current
67457-255	Levetiracetam	Levetiracetam	Mylan Institutional LLC	NDA	Current
67457-265	Levetiracetam	Levetiracetam	Mylan Institutional LLC	NDA	Current
67457-265	Levetiracetam	Levetiracetam	Mylan Institutional LLC	NDA	Current
67457-265	Levetiracetam	Levetiracetam	Mylan Institutional LLC	NDA	Current
67457-265	Levetiracetam	Levetiracetam	Mylan Institutional LLC	NDA	Current
67457-265	Levetiracetam	Levetiracetam	Mylan Institutional LLC	NDA	Current
67457-266	Levetiracetam	Levetiracetam	Mylan Institutional LLC	NDA	Current
67457-266	Levetiracetam	Levetiracetam	Mylan Institutional LLC	NDA	Current
67457-266	Levetiracetam	Levetiracetam	Mylan Institutional LLC	NDA	Current
67457-266	Levetiracetam	Levetiracetam	Mylan Institutional LLC	NDA	Current
67457-266	Levetiracetam	Levetiracetam	Mylan Institutional LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
77816	SUPPL	2024-03-13
77801	SUPPL	2024-03-13
67075	SUPPL	2021-04-16
67053	SUPPL	2021-04-14
61032	SUPPL	2019-11-22
61026	SUPPL	2019-11-22
54898	SUPPL	2018-07-16
54876	SUPPL	2018-07-13
48712	SUPPL	2017-06-13
48708	SUPPL	2017-06-13
45920	SUPPL	2016-11-22
45919	SUPPL	2016-11-22
45935	SUPPL	2016-11-21
45934	SUPPL	2016-11-21
44861	ORIG	2012-06-14
43407	ORIG	2012-06-14
10070	ORIG	2011-11-14
40192	ORIG	2011-11-10