Application 022285

Type: NDA
Sponsor: UCB INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	KEPPRA XR	LEVETIRACETAM	TABLET, EXTENDED RELEASE;ORAL	500MG	Yes	No
002	KEPPRA XR	LEVETIRACETAM	TABLET, EXTENDED RELEASE;ORAL	750MG	Yes	Yes

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
N022285-001	KEPPRA XR	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2008-09-12
N022285-002	KEPPRA XR	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2009-02-12

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N022285-001	AB
N022285-002	AB

Orange Book patents#

Current patent rows page 1 of 1 · 2 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N022285-001	7858122	2028-09-17		Drug product	2011-01-07
N022285-002	7858122	2028-09-17		Drug product

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 · 82 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	N022285-001	KEPPRA XR	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2008-09-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022285-002	KEPPRA XR	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2009-02-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022285-001	KEPPRA XR	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2008-09-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022285-002	KEPPRA XR	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2009-02-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022285-001	KEPPRA XR	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2008-09-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022285-002	KEPPRA XR	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2009-02-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022285-001	KEPPRA XR	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2008-09-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022285-002	KEPPRA XR	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2009-02-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022285-001	KEPPRA XR	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2008-09-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022285-002	KEPPRA XR	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2009-02-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022285-001	KEPPRA XR	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2008-09-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022285-002	KEPPRA XR	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2009-02-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022285-001	KEPPRA XR	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2008-09-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022285-002	KEPPRA XR	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2009-02-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022285-001	KEPPRA XR	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2008-09-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022285-002	KEPPRA XR	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2009-02-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022285-001	KEPPRA XR	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2008-09-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022285-002	KEPPRA XR	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2009-02-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022285-001	KEPPRA XR	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2008-09-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022285-002	KEPPRA XR	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2009-02-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022285-001	KEPPRA XR	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2008-09-12	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022285-002	KEPPRA XR	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2009-02-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022285-001	KEPPRA XR	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2008-09-12	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022285-002	KEPPRA XR	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2009-02-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022285-001	KEPPRA XR	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2008-09-12	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022285-002	KEPPRA XR	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2009-02-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022285-001	KEPPRA XR	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2008-09-12	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N022285-002	KEPPRA XR	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2009-02-12	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022285-001	KEPPRA XR	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2008-09-12	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022285-002	KEPPRA XR	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2009-02-12	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022285-001	KEPPRA XR	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2008-09-12	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022285-002	KEPPRA XR	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2009-02-12	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022285-001	KEPPRA XR	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2008-09-12	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022285-002	KEPPRA XR	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2009-02-12	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022285-001	KEPPRA XR	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2008-09-12	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022285-002	KEPPRA XR	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2009-02-12	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022285-001	KEPPRA XR	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2008-09-12	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N022285-002	KEPPRA XR	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2009-02-12	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022285-001	KEPPRA XR	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2008-09-12	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N022285-002	KEPPRA XR	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2009-02-12	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 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	N022285-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022285-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022285-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022285-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022285-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022285-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022285-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022285-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022285-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022285-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022285-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022285-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022285-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022285-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022285-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022285-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022285-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022285-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022285-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022285-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022285-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022285-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022285-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022285-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022285-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022285-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022285-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N022285-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022285-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022285-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022285-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022285-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022285-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022285-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022285-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022285-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022285-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N022285-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022285-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N022285-002	AB	1	`782e0a99824c…`

Observed Orange Book patent history#

Patent history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N022285-001	7858122	2028-09-17	Drug product	2011-01-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022285-002	7858122	2028-09-17	Drug product		`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022285-001	7858122	2028-09-17	Drug product	2011-01-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022285-002	7858122	2028-09-17	Drug product		`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022285-001	7858122	2028-09-17	Drug product	2011-01-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022285-002	7858122	2028-09-17	Drug product		`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022285-001	7858122	2028-09-17	Drug product	2011-01-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022285-002	7858122	2028-09-17	Drug product		`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022285-001	7858122	2028-09-17	Drug product	2011-01-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022285-002	7858122	2028-09-17	Drug product		`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022285-001	7858122	2028-09-17	Drug product	2011-01-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022285-002	7858122	2028-09-17	Drug product		`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022285-001	7858122	2028-09-17	Drug product	2011-01-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022285-002	7858122	2028-09-17	Drug product		`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022285-001	7858122	2028-09-17	Drug product	2011-01-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022285-002	7858122	2028-09-17	Drug product		`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022285-001	7858122	2028-09-17	Drug product	2011-01-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022285-002	7858122	2028-09-17	Drug product		`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022285-001	7858122	2028-09-17	Drug product	2011-01-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022285-002	7858122	2028-09-17	Drug product		`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022285-001	7858122	2028-09-17	Drug product	2011-01-07	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022285-002	7858122	2028-09-17	Drug product		`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022285-001	7858122	2028-09-17	Drug product	2011-01-07	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022285-002	7858122	2028-09-17	Drug product		`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022285-001	7858122	2028-09-17	Drug product	2011-01-07	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022285-002	7858122	2028-09-17	Drug product		`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022285-001	7858122	2028-09-17	Drug product	2011-01-07	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N022285-002	7858122	2028-09-17	Drug product		`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022285-001	7858122	2028-09-17	Drug product	2011-01-07	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022285-002	7858122	2028-09-17	Drug product		`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022285-001	7858122	2028-09-17	Drug product	2011-01-07	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022285-002	7858122	2028-09-17	Drug product		`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022285-001	7858122	2028-09-17	Drug product	2011-01-07	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022285-002	7858122	2028-09-17	Drug product		`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022285-001	7858122	2028-09-17	Drug product	2011-01-07	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022285-002	7858122	2028-09-17	Drug product		`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022285-001	7858122	2028-09-17	Drug product	2011-01-07	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N022285-002	7858122	2028-09-17	Drug product		`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022285-001	7858122	2028-09-17	Drug product	2011-01-07	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N022285-002	7858122	2028-09-17	Drug product		`782e0a99824c…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Keppra XR	LEVETIRACETAM	UCB, Inc.	2919e43b-69a8-434c-a2d2-1f3ecd7554c0	2025-06-24	Warnings, Adverse reactions	Exact identifier application applno (NDA): 022285 application number: NDA022285 ndc (product): 50474-599 ndc (product): 50474-598

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 14 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50474-598	Keppra	levetiracetam	UCB, Inc.	NDA	Current
50474-598	Keppra	levetiracetam	UCB, Inc.	NDA	Current
50474-598	Keppra	levetiracetam	UCB, Inc.	NDA	Current
50474-598	Keppra	levetiracetam	UCB, Inc.	NDA	Current
50474-598	Keppra	levetiracetam	UCB, Inc.	NDA	Current
50474-599	Keppra	levetiracetam	UCB, Inc.	NDA	Current
50474-599	Keppra	levetiracetam	UCB, Inc.	NDA	Current
50474-599	Keppra	levetiracetam	UCB, Inc.	NDA	Current
50474-599	Keppra	levetiracetam	UCB, Inc.	NDA	Current
50474-599	Keppra	levetiracetam	UCB, Inc.	NDA	Current
65084-460	Keppra	levetiracetam	Mckesson Rxpak Inc	NDA	Current
65084-461	Keppra	levetiracetam	Mckesson Rxpak Inc	NDA	Current
70518-2109	Keppra	levetiracetam	REMEDYREPACK INC.	NDA	Current
70518-2109	Keppra	levetiracetam	REMEDYREPACK INC.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
77821	SUPPL	2024-03-13
77793	SUPPL	2024-03-13
77792	SUPPL	2024-03-13
75140	SUPPL	2023-08-18
75120	SUPPL	2023-08-18
64809	SUPPL	2020-10-02
64808	SUPPL	2020-10-02
64780	SUPPL	2020-10-01
60655	SUPPL	2019-10-24
60651	SUPPL	2019-10-24
60649	SUPPL	2019-10-24
50219	SUPPL	2017-10-30
50173	SUPPL	2017-10-25
48143	SUPPL	2017-04-27
48106	SUPPL	2017-04-25
45763	SUPPL	2016-11-01
45705	SUPPL	2016-10-28
29527	SUPPL	2016-04-08
17198	SUPPL	2016-04-07
29524	SUPPL	2015-03-12
17196	SUPPL	2015-03-12
29526	SUPPL	2014-08-11
17197	SUPPL	2014-08-08
38503	SUPPL	2014-08-04
29525	SUPPL	2014-08-04
7176	SUPPL	2014-03-11
7175	SUPPL	2014-03-11
38504	SUPPL	2014-03-10
38502	SUPPL	2014-03-10
38501	SUPPL	2013-07-30
38500	SUPPL	2013-07-30
29523	SUPPL	2013-07-26
7173	SUPPL	2013-07-26
7174	SUPPL	2011-08-12
38499	SUPPL	2009-05-12
38498	SUPPL	2009-05-12
7172	SUPPL	2009-05-04
7171	SUPPL	2009-05-04
7170	SUPPL	2009-02-18
38497	SUPPL	2009-02-13
42478	ORIG	2009-01-06
24274	ORIG	2009-01-06
44180	ORIG	2008-09-19
38496	ORIG	2008-09-16
7169	ORIG	2008-09-16
51297	SUPPL	1900-01-01
51296	SUPPL	1900-01-01
51295	SUPPL	1900-01-01
51294	SUPPL	1900-01-01