Application 091627

Type: ANDA
Sponsor: SAGENT PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LEVETIRACETAM	LEVETIRACETAM	INJECTABLE;INTRAVENOUS	500MG/5ML (100MG/ML)	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A091627-001	LEVETIRACETAM	LEVETIRACETAM	500MG/5ML (100MG/ML)	INJECTABLE / INTRAVENOUS	AP		2013-06-26

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A091627-001	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 2 · 43 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
2026-09-14 22:38:34	2026-08	A091627-001	LEVETIRACETAM	500MG/5ML (100MG/ML)	INJECTABLE / INTRAVENOUS	AP	2013-06-26	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A091627-001	LEVETIRACETAM	500MG/5ML (100MG/ML)	INJECTABLE / INTRAVENOUS	AP	2013-06-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091627-001	LEVETIRACETAM	500MG/5ML (100MG/ML)	INJECTABLE / INTRAVENOUS	AP	2013-06-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091627-001	LEVETIRACETAM	500MG/5ML (100MG/ML)	INJECTABLE / INTRAVENOUS	AP	2013-06-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091627-001	LEVETIRACETAM	500MG/5ML (100MG/ML)	INJECTABLE / INTRAVENOUS	AP	2013-06-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091627-001	LEVETIRACETAM	500MG/5ML (100MG/ML)	INJECTABLE / INTRAVENOUS	AP	2013-06-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091627-001	LEVETIRACETAM	500MG/5ML (100MG/ML)	INJECTABLE / INTRAVENOUS	AP	2013-06-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091627-001	LEVETIRACETAM	500MG/5ML (100MG/ML)	INJECTABLE / INTRAVENOUS	AP	2013-06-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091627-001	LEVETIRACETAM	500MG/5ML (100MG/ML)	INJECTABLE / INTRAVENOUS	AP	2013-06-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091627-001	LEVETIRACETAM	500MG/5ML (100MG/ML)	INJECTABLE / INTRAVENOUS	AP	2013-06-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091627-001	LEVETIRACETAM	500MG/5ML (100MG/ML)	INJECTABLE / INTRAVENOUS	AP	2013-06-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091627-001	LEVETIRACETAM	500MG/5ML (100MG/ML)	INJECTABLE / INTRAVENOUS	AP	2013-06-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091627-001	LEVETIRACETAM	500MG/5ML (100MG/ML)	INJECTABLE / INTRAVENOUS	AP	2013-06-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091627-001	LEVETIRACETAM	500MG/5ML (100MG/ML)	INJECTABLE / INTRAVENOUS	AP	2013-06-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091627-001	LEVETIRACETAM	500MG/5ML (100MG/ML)	INJECTABLE / INTRAVENOUS	AP	2013-06-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091627-001	LEVETIRACETAM	500MG/5ML (100MG/ML)	INJECTABLE / INTRAVENOUS	AP	2013-06-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091627-001	LEVETIRACETAM	500MG/5ML (100MG/ML)	INJECTABLE / INTRAVENOUS	AP	2013-06-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091627-001	LEVETIRACETAM	500MG/5ML (100MG/ML)	INJECTABLE / INTRAVENOUS	AP	2013-06-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091627-001	LEVETIRACETAM	500MG/5ML (100MG/ML)	INJECTABLE / INTRAVENOUS	AP	2013-06-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091627-001	LEVETIRACETAM	500MG/5ML (100MG/ML)	INJECTABLE / INTRAVENOUS	AP	2013-06-26	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091627-001	LEVETIRACETAM	500MG/5ML (100MG/ML)	INJECTABLE / INTRAVENOUS	AP	2013-06-26	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091627-001	LEVETIRACETAM	500MG/5ML (100MG/ML)	INJECTABLE / INTRAVENOUS	AP	2013-06-26	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091627-001	LEVETIRACETAM	500MG/5ML (100MG/ML)	INJECTABLE / INTRAVENOUS	AP	2013-06-26	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091627-001	LEVETIRACETAM	500MG/5ML (100MG/ML)	INJECTABLE / INTRAVENOUS	AP	2013-06-26	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091627-001	LEVETIRACETAM	500MG/5ML (100MG/ML)	INJECTABLE / INTRAVENOUS	AP	2013-06-26	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091627-001	LEVETIRACETAM	500MG/5ML (100MG/ML)	INJECTABLE / INTRAVENOUS	AP	2013-06-26	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091627-001	LEVETIRACETAM	500MG/5ML (100MG/ML)	INJECTABLE / INTRAVENOUS	AP	2013-06-26	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091627-001	LEVETIRACETAM	500MG/5ML (100MG/ML)	INJECTABLE / INTRAVENOUS	AP	2013-06-26	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091627-001	LEVETIRACETAM	500MG/5ML (100MG/ML)	INJECTABLE / INTRAVENOUS	AP	2013-06-26	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091627-001	LEVETIRACETAM	500MG/5ML (100MG/ML)	INJECTABLE / INTRAVENOUS	AP	2013-06-26	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A091627-001	LEVETIRACETAM	500MG/5ML (100MG/ML)	INJECTABLE / INTRAVENOUS	AP	2013-06-26	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A091627-001	LEVETIRACETAM	500MG/5ML (100MG/ML)	INJECTABLE / INTRAVENOUS	AP	2013-06-26	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091627-001	LEVETIRACETAM	500MG/5ML (100MG/ML)	INJECTABLE / INTRAVENOUS	AP	2013-06-26	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091627-001	LEVETIRACETAM	500MG/5ML (100MG/ML)	INJECTABLE / INTRAVENOUS	AP	2013-06-26	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091627-001	LEVETIRACETAM	500MG/5ML (100MG/ML)	INJECTABLE / INTRAVENOUS	AP	2013-06-26	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091627-001	LEVETIRACETAM	500MG/5ML (100MG/ML)	INJECTABLE / INTRAVENOUS	AP	2013-06-26	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A091627-001	LEVETIRACETAM	500MG/5ML (100MG/ML)	INJECTABLE / INTRAVENOUS	AP	2013-06-26	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A091627-001	LEVETIRACETAM	500MG/5ML (100MG/ML)	INJECTABLE / INTRAVENOUS	AP	2013-06-26	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091627-001	LEVETIRACETAM	500MG/5ML (100MG/ML)	INJECTABLE / INTRAVENOUS	AP	2013-06-26	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A091627-001	LEVETIRACETAM	500MG/5ML (100MG/ML)	INJECTABLE / INTRAVENOUS	AP	2013-06-26	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A091627-001	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A091627-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091627-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091627-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091627-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091627-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091627-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091627-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091627-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091627-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091627-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091627-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091627-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091627-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091627-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091627-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091627-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091627-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091627-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091627-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091627-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091627-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091627-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091627-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091627-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091627-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091627-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091627-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091627-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091627-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A091627-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A091627-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091627-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091627-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091627-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091627-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A091627-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A091627-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091627-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A091627-001	AP	1	`f41ea6bd6efb…`

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 8 of 9 · 166 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Levetiracetam	LEVETIRACETAM IN SODIUM CHLORIDE	Eugia US LLC	e5eb4c89-8ee9-4474-9cb1-c3b3dc262a4a	2024-04-01	Warnings, Adverse reactions	Name fallback brand name: Levetiracetam
Levetiracetam	LEVETIRACETAM	WG Critical Care, LLC	62f3d1c8-ca5b-4760-9fc9-41e4fb4cc926	2024-03-29	Warnings, Adverse reactions	Name fallback brand name: Levetiracetam generic name: LEVETIRACETAM
LEVETIRACETAM	LEVETIRACETAM	Solco healthcare U.S., LLC	bc8644ed-3320-47b5-adf3-8b972bea8abd	2024-03-28	Warnings, Adverse reactions	Name fallback brand name: LEVETIRACETAM generic name: LEVETIRACETAM
Levetiracetam	LEVETIRACETAM	Solco Healthcare US, LLC	57f09129-7151-4a75-9d73-9dd32f74ba43	2024-03-27	Warnings, Adverse reactions	Name fallback brand name: Levetiracetam generic name: LEVETIRACETAM
Levetiracetam	LEVETIRACETAM	Solco Healthcare US, LLC	dd713e60-478c-43cd-b680-ff594a0b3864	2024-03-27	Warnings, Adverse reactions	Name fallback brand name: Levetiracetam generic name: LEVETIRACETAM
Levetiracetam	LEVETIRACETAM	PAI Holdings, LLC dba PAI Pharma	9dca1330-52ca-47a4-a134-ec55c9d5786d	2024-03-27	Warnings, Adverse reactions	Name fallback brand name: Levetiracetam generic name: LEVETIRACETAM
ELEPSIA XR 1000 MG	LEVETIRACETAM	TRIPOINT THERAPEUTICS, LLC	cac83d47-88a2-4447-a0c0-90b44ffda0ac	2024-03-25	Warnings, Adverse reactions	Name fallback generic name: LEVETIRACETAM
Levetiracetam	LEVETIRACETAM	Gland Pharma Limited	aa883d9c-c6cd-44ab-a1de-058985e4f97f	2024-03-25	Warnings, Adverse reactions	Name fallback brand name: Levetiracetam generic name: LEVETIRACETAM
Levetiracetam	LEVETIRACETAM	Mylan Institutional LLC	70e52e89-3844-4cd9-a406-b29e9520a12c	2024-03-15	Warnings, Adverse reactions	Name fallback brand name: Levetiracetam generic name: LEVETIRACETAM
Levetiracetam	LEVETIRACETAM	Proficient Rx LP	6bdbc193-d86b-4bd5-8e88-4ea964d2cdde	2024-03-01	Warnings, Adverse reactions	Name fallback brand name: Levetiracetam generic name: LEVETIRACETAM
Levetiracetam	LEVETIRACETAM	Patrin Pharma, Inc.	49117cee-a96c-4593-91a7-8a133e3f0939	2024-02-15	Warnings, Adverse reactions	Name fallback brand name: Levetiracetam generic name: LEVETIRACETAM
levetiracetam	LEVETIRACETAM	MAJOR PHARMACEUTICALS	6913c611-4994-4501-8ed9-45161f90373e	2023-12-28	Warnings, Adverse reactions	Name fallback brand name: levetiracetam generic name: LEVETIRACETAM
Levetiracetam	LEVETIRACETAM	WG Critical Care, LLC	5e5b0ed3-b104-45a7-bb3e-ee56febb46e8	2023-10-30	Warnings, Adverse reactions	Name fallback brand name: Levetiracetam generic name: LEVETIRACETAM
Levetiracetam	LEVETIRACETAM	Natco Pharma USA LLC	34af3602-0188-4d2e-904b-2e40000bb45c	2023-08-05	Warnings, Adverse reactions	Name fallback brand name: Levetiracetam generic name: LEVETIRACETAM
LEVETIRACETAM	LEVETIRACETAM	Armas Pharmaceuticals Inc.	7be45c40-8d75-4c40-97a4-95067129bc2a	2023-07-24	Warnings, Adverse reactions	Name fallback brand name: LEVETIRACETAM generic name: LEVETIRACETAM
Levetiracetam ER	LEVETIRACETAM	Proficient Rx LP	a0ad8200-70c9-4f4f-86c5-4a8c6c9f0223	2022-12-01	Warnings, Adverse reactions	Name fallback generic name: LEVETIRACETAM
Levetiracetam ER	LEVETIRACETAM	Proficient Rx LP	57b9dccb-6ee6-4e89-ab26-4c478e2df2b5	2022-04-01	Warnings, Adverse reactions	Name fallback generic name: LEVETIRACETAM
Levetiracetam	LEVETIRACETAM	Fresenius Kabi USA, LLC	cc4a06f1-6509-4650-b20c-259a39353733	2022-02-28	Warnings, Adverse reactions	Name fallback brand name: Levetiracetam generic name: LEVETIRACETAM
Levetiracetam	LEVETIRACETAM	Fresenius Kabi USA, LLC	cc41696c-9cf0-4410-bacc-09132ee805ce	2022-01-24	Warnings, Adverse reactions	Name fallback brand name: Levetiracetam generic name: LEVETIRACETAM
Levetiracetam	LEVETIRACETAM INJECTION	Dr.Reddy's Laboratories Inc	be8ec971-c4f1-3e53-77e1-8337d9d506eb	2021-12-31	Warnings, Adverse reactions	Name fallback brand name: Levetiracetam

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
25021-780	Levetiracetam	Levetiracetam	Sagent Pharmaceuticals	ANDA	Current
25021-780	Levetiracetam	Levetiracetam	Sagent Pharmaceuticals	ANDA	Current
25021-780	Levetiracetam	Levetiracetam	Sagent Pharmaceuticals	ANDA	Current