Application 206880

Type
ANDA
Sponsor
GLAND PHARMA LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LEVETIRACETAM IN SODIUM CHLORIDELEVETIRACETAMINJECTABLE;INTRAVENOUS500MG/100ML (5MG/ML)NoNo
002LEVETIRACETAM IN SODIUM CHLORIDELEVETIRACETAMINJECTABLE;INTRAVENOUS1000MG/100ML (10MG/ML)NoNo
003LEVETIRACETAM IN SODIUM CHLORIDELEVETIRACETAMINJECTABLE;INTRAVENOUS1500MG/100ML (15MG/ML)NoNo

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A206880-001LEVETIRACETAM IN SODIUM CHLORIDELEVETIRACETAM500MG/100ML (5MG/ML)INJECTABLE / INTRAVENOUSAP2017-10-25
A206880-002LEVETIRACETAM IN SODIUM CHLORIDELEVETIRACETAM1GM/100ML (10MG/ML)INJECTABLE / INTRAVENOUSAP2017-10-25
A206880-003LEVETIRACETAM IN SODIUM CHLORIDELEVETIRACETAM1.5GM/100ML (15MG/ML)INJECTABLE / INTRAVENOUSAP2017-10-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A206880-001AP
A206880-002AP
A206880-003AP

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 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A206880-001LEVETIRACETAM IN SODIUM CHLORIDE500MG/100ML (5MG/ML)INJECTABLE / INTRAVENOUSAP2017-10-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206880-002LEVETIRACETAM IN SODIUM CHLORIDE1GM/100ML (10MG/ML)INJECTABLE / INTRAVENOUSAP2017-10-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206880-003LEVETIRACETAM IN SODIUM CHLORIDE1.5GM/100ML (15MG/ML)INJECTABLE / INTRAVENOUSAP2017-10-25011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206880-001LEVETIRACETAM IN SODIUM CHLORIDE500MG/100ML (5MG/ML)INJECTABLE / INTRAVENOUSAP2017-10-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206880-002LEVETIRACETAM IN SODIUM CHLORIDE1GM/100ML (10MG/ML)INJECTABLE / INTRAVENOUSAP2017-10-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206880-003LEVETIRACETAM IN SODIUM CHLORIDE1.5GM/100ML (15MG/ML)INJECTABLE / INTRAVENOUSAP2017-10-2531067a03dcf5…
2025-08-23 18:47 UTC2025-08A206880-001LEVETIRACETAM IN SODIUM CHLORIDE500MG/100ML (5MG/ML)INJECTABLE / INTRAVENOUSAP2017-10-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206880-002LEVETIRACETAM IN SODIUM CHLORIDE1GM/100ML (10MG/ML)INJECTABLE / INTRAVENOUSAP2017-10-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206880-003LEVETIRACETAM IN SODIUM CHLORIDE1.5GM/100ML (15MG/ML)INJECTABLE / INTRAVENOUSAP2017-10-256a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206880-001LEVETIRACETAM IN SODIUM CHLORIDE500MG/100ML (5MG/ML)INJECTABLE / INTRAVENOUSAP2017-10-25fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206880-002LEVETIRACETAM IN SODIUM CHLORIDE1GM/100ML (10MG/ML)INJECTABLE / INTRAVENOUSAP2017-10-25fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206880-003LEVETIRACETAM IN SODIUM CHLORIDE1.5GM/100ML (15MG/ML)INJECTABLE / INTRAVENOUSAP2017-10-25fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206880-001LEVETIRACETAM IN SODIUM CHLORIDE500MG/100ML (5MG/ML)INJECTABLE / INTRAVENOUSAP2017-10-25b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206880-002LEVETIRACETAM IN SODIUM CHLORIDE1GM/100ML (10MG/ML)INJECTABLE / INTRAVENOUSAP2017-10-25b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206880-003LEVETIRACETAM IN SODIUM CHLORIDE1.5GM/100ML (15MG/ML)INJECTABLE / INTRAVENOUSAP2017-10-25b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206880-001LEVETIRACETAM IN SODIUM CHLORIDE500MG/100ML (5MG/ML)INJECTABLE / INTRAVENOUSAP2017-10-2503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206880-002LEVETIRACETAM IN SODIUM CHLORIDE1GM/100ML (10MG/ML)INJECTABLE / INTRAVENOUSAP2017-10-2503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206880-003LEVETIRACETAM IN SODIUM CHLORIDE1.5GM/100ML (15MG/ML)INJECTABLE / INTRAVENOUSAP2017-10-2503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206880-001LEVETIRACETAM IN SODIUM CHLORIDE500MG/100ML (5MG/ML)INJECTABLE / INTRAVENOUSAP2017-10-252680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206880-002LEVETIRACETAM IN SODIUM CHLORIDE1GM/100ML (10MG/ML)INJECTABLE / INTRAVENOUSAP2017-10-252680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206880-003LEVETIRACETAM IN SODIUM CHLORIDE1.5GM/100ML (15MG/ML)INJECTABLE / INTRAVENOUSAP2017-10-252680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206880-001LEVETIRACETAM IN SODIUM CHLORIDE500MG/100ML (5MG/ML)INJECTABLE / INTRAVENOUSAP2017-10-255bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206880-002LEVETIRACETAM IN SODIUM CHLORIDE1GM/100ML (10MG/ML)INJECTABLE / INTRAVENOUSAP2017-10-255bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206880-003LEVETIRACETAM IN SODIUM CHLORIDE1.5GM/100ML (15MG/ML)INJECTABLE / INTRAVENOUSAP2017-10-255bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206880-001LEVETIRACETAM IN SODIUM CHLORIDE500MG/100ML (5MG/ML)INJECTABLE / INTRAVENOUSAP2017-10-25d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206880-002LEVETIRACETAM IN SODIUM CHLORIDE1GM/100ML (10MG/ML)INJECTABLE / INTRAVENOUSAP2017-10-25d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206880-003LEVETIRACETAM IN SODIUM CHLORIDE1.5GM/100ML (15MG/ML)INJECTABLE / INTRAVENOUSAP2017-10-25d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A206880-001LEVETIRACETAM IN SODIUM CHLORIDE500MG/100ML (5MG/ML)INJECTABLE / INTRAVENOUSAP2017-10-25d06236e962d9…
2024-10-29 15:01 UTC2024-10A206880-002LEVETIRACETAM IN SODIUM CHLORIDE1GM/100ML (10MG/ML)INJECTABLE / INTRAVENOUSAP2017-10-25d06236e962d9…
2024-10-29 15:01 UTC2024-10A206880-003LEVETIRACETAM IN SODIUM CHLORIDE1.5GM/100ML (15MG/ML)INJECTABLE / INTRAVENOUSAP2017-10-25d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206880-001LEVETIRACETAM IN SODIUM CHLORIDE500MG/100ML (5MG/ML)INJECTABLE / INTRAVENOUSAP2017-10-2579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206880-002LEVETIRACETAM IN SODIUM CHLORIDE1GM/100ML (10MG/ML)INJECTABLE / INTRAVENOUSAP2017-10-2579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206880-003LEVETIRACETAM IN SODIUM CHLORIDE1.5GM/100ML (15MG/ML)INJECTABLE / INTRAVENOUSAP2017-10-2579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206880-001LEVETIRACETAM IN SODIUM CHLORIDE500MG/100ML (5MG/ML)INJECTABLE / INTRAVENOUSAP2017-10-25301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206880-002LEVETIRACETAM IN SODIUM CHLORIDE1GM/100ML (10MG/ML)INJECTABLE / INTRAVENOUSAP2017-10-25301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206880-003LEVETIRACETAM IN SODIUM CHLORIDE1.5GM/100ML (15MG/ML)INJECTABLE / INTRAVENOUSAP2017-10-25301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A206880-001LEVETIRACETAM IN SODIUM CHLORIDE500MG/100ML (5MG/ML)INJECTABLE / INTRAVENOUSAP2017-10-251e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A206880-002LEVETIRACETAM IN SODIUM CHLORIDE1GM/100ML (10MG/ML)INJECTABLE / INTRAVENOUSAP2017-10-251e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A206880-003LEVETIRACETAM IN SODIUM CHLORIDE1.5GM/100ML (15MG/ML)INJECTABLE / INTRAVENOUSAP2017-10-251e350fbaab3a…
2024-05-31 18:47 UTC2024-05A206880-001LEVETIRACETAM IN SODIUM CHLORIDE500MG/100ML (5MG/ML)INJECTABLE / INTRAVENOUSAP2017-10-258072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A206880-001AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206880-002AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206880-003AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206880-001AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206880-002AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206880-003AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A206880-001AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206880-002AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206880-003AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206880-001AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206880-002AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206880-003AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206880-001AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206880-002AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206880-003AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206880-001AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206880-002AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206880-003AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206880-001AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206880-002AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206880-003AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206880-001AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206880-002AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206880-003AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206880-001AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206880-002AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206880-003AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A206880-001AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10A206880-002AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10A206880-003AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206880-001AP179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206880-002AP179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206880-003AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206880-001AP1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206880-002AP1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206880-003AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A206880-001AP11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A206880-002AP11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A206880-003AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A206880-001AP18072bd15b7f6…

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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
levetiracetamLEVETIRACETAMSagent Pharmaceuticalsd2de9565-0c0b-4957-bafa-1a286103709e2024-04-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206880
application number: ANDA206880
LevetiracetamLEVETIRACETAMGland Pharma Limitedaa883d9c-c6cd-44ab-a1de-058985e4f97f2024-03-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206880
application number: ANDA206880
ndc (product): 68083-152
ndc (product): 68083-154
ndc (product): 68083-153
LevetiracetamLEVETIRACETAM INJECTIONDr.Reddy's Laboratories Incbe8ec971-c4f1-3e53-77e1-8337d9d506eb2021-12-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206880
application number: ANDA206880
ndc (product): 43598-757
ndc (product): 43598-755
ndc (product): 43598-759
LevetiracetamLEVETIRACETAM INJECTIONDr.Reddy's Laboratories Inc0a9234b7-46b1-8e6c-a992-90f86cfb6e002021-12-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206880
application number: ANDA206880
ndc (product): 43598-637
ndc (product): 43598-636
ndc (product): 43598-635

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 33 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
43598-635LevetiracetamLevetiracetam InjectionDr.Reddy's Laboratories IncANDACurrent
43598-635LevetiracetamLevetiracetam InjectionDr.Reddy's Laboratories IncANDACurrent
43598-636LevetiracetamLevetiracetam InjectionDr.Reddy's Laboratories IncANDACurrent
43598-636LevetiracetamLevetiracetam InjectionDr.Reddy's Laboratories IncANDACurrent
43598-637LevetiracetamLevetiracetam InjectionDr.Reddy's Laboratories IncANDACurrent
43598-637LevetiracetamLevetiracetam InjectionDr.Reddy's Laboratories IncANDACurrent
43598-755LevetiracetamLevetiracetam InjectionDr.Reddy's Laboratories IncANDACurrent
43598-755LevetiracetamLevetiracetam InjectionDr.Reddy's Laboratories IncANDACurrent
43598-757LevetiracetamLevetiracetam InjectionDr.Reddy's Laboratories IncANDACurrent
43598-757LevetiracetamLevetiracetam InjectionDr.Reddy's Laboratories IncANDACurrent
43598-759LevetiracetamLevetiracetam InjectionDr.Reddy's Laboratories IncANDACurrent
43598-759LevetiracetamLevetiracetam InjectionDr.Reddy's Laboratories IncANDACurrent
68083-152LevetiracetamLevetiracetamGland Pharma LimitedANDACurrent
68083-152LevetiracetamLevetiracetamGland Pharma LimitedANDACurrent
68083-152LevetiracetamLevetiracetamGland Pharma LimitedANDACurrent
68083-153LevetiracetamLevetiracetamGland Pharma LimitedANDACurrent
68083-153LevetiracetamLevetiracetamGland Pharma LimitedANDACurrent
68083-153LevetiracetamLevetiracetamGland Pharma LimitedANDACurrent
68083-154LevetiracetamLevetiracetamGland Pharma LimitedANDACurrent
68083-154LevetiracetamLevetiracetamGland Pharma LimitedANDACurrent
68083-154LevetiracetamLevetiracetamGland Pharma LimitedANDACurrent
70860-602LevetiracetamLevetiracetamAthenex Pharmaceutical Division, LLC.ANDACurrent
70860-602LevetiracetamLevetiracetamAthenex Pharmaceutical Division, LLC.ANDACurrent
70860-602LevetiracetamLevetiracetamAthenex Pharmaceutical Division, LLC.ANDACurrent
70860-602LevetiracetamLevetiracetamAthenex Pharmaceutical Division, LLC.ANDACurrent
70860-603LevetiracetamLevetiracetamAthenex Pharmaceutical Division, LLC.ANDACurrent
70860-603LevetiracetamLevetiracetamAthenex Pharmaceutical Division, LLC.ANDACurrent
70860-603LevetiracetamLevetiracetamAthenex Pharmaceutical Division, LLC.ANDACurrent
70860-603LevetiracetamLevetiracetamAthenex Pharmaceutical Division, LLC.ANDACurrent
70860-604LevetiracetamLevetiracetamAthenex Pharmaceutical Division, LLC.ANDACurrent
70860-604LevetiracetamLevetiracetamAthenex Pharmaceutical Division, LLC.ANDACurrent
70860-604LevetiracetamLevetiracetamAthenex Pharmaceutical Division, LLC.ANDACurrent
70860-604LevetiracetamLevetiracetamAthenex Pharmaceutical Division, LLC.ANDACurrent