Application 217806

Type
NDA
Sponsor
ELI LILLY AND CO

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ZEPBOUND (AUTOINJECTOR)TIRZEPATIDESOLUTION;SUBCUTANEOUS2.5MG/0.5ML (2.5MG/0.5ML)YesYes
002ZEPBOUND (AUTOINJECTOR)TIRZEPATIDESOLUTION;SUBCUTANEOUS5MG/0.5ML (5MG/0.5ML)YesYes
003ZEPBOUND (AUTOINJECTOR)TIRZEPATIDESOLUTION;SUBCUTANEOUS7.5MG/0.5ML (7.5MG/0.5ML)YesYes
004ZEPBOUND (AUTOINJECTOR)TIRZEPATIDESOLUTION;SUBCUTANEOUS10MG/0.5ML (10MG/0.5ML)YesYes
005ZEPBOUND (AUTOINJECTOR)TIRZEPATIDESOLUTION;SUBCUTANEOUS12.5MG/0.5ML (12.5MG/0.5ML)YesYes
006ZEPBOUND (AUTOINJECTOR)TIRZEPATIDESOLUTION;SUBCUTANEOUS15MG/0.5ML (15MG/0.5ML)YesYes
007ZEPBOUNDTIRZEPATIDESOLUTION;SUBCUTANEOUS2.5MG/0.5ML (2.5MG/0.5ML)YesYes
008ZEPBOUNDTIRZEPATIDESOLUTION;SUBCUTANEOUS5MG/0.5ML (5MG/0.5ML)YesYes
009ZEPBOUNDTIRZEPATIDESOLUTION;SUBCUTANEOUS7.5MG/0.5ML (7.5MG/0.5ML)YesYes
010ZEPBOUNDTIRZEPATIDESOLUTION;SUBCUTANEOUS10MG/0.5ML (10MG/0.5ML)YesYes
011ZEPBOUNDTIRZEPATIDESOLUTION;SUBCUTANEOUS12.5MG/0.5ML (12.5MG/0.5ML)YesYes
012ZEPBOUNDTIRZEPATIDESOLUTION;SUBCUTANEOUS15MG/0.5ML (15MG/0.5ML)YesYes
013ZEPBOUNDTIRZEPATIDESOLUTION;SUBCUTANEOUS10MG/2.4ML (4.17MG/ML)YesYes
014ZEPBOUNDTIRZEPATIDESOLUTION;SUBCUTANEOUS20MG/2.4ML (8.33MG/ML)YesYes
015ZEPBOUNDTIRZEPATIDESOLUTION;SUBCUTANEOUS30MG/2.4ML (12.5MG/ML)YesYes
016ZEPBOUNDTIRZEPATIDESOLUTION;SUBCUTANEOUS40MG/2.4ML (16.7MG/ML)YesYes
017ZEPBOUNDTIRZEPATIDESOLUTION;SUBCUTANEOUS50MG/2.4ML (20.8MG/ML)YesYes
018ZEPBOUNDTIRZEPATIDESOLUTION;SUBCUTANEOUS60MG/2.4ML (25MG/ML)YesYes
019ZEPBOUND KWIKPENTIRZEPATIDESOLUTION;SUBCUTANEOUS10MG/2.4ML (4.17MG/ML)YesYes
020ZEPBOUND KWIKPENTIRZEPATIDESOLUTION;SUBCUTANEOUS20MG/2.4ML (8.33MG/ML)YesYes
021ZEPBOUND KWIKPENTIRZEPATIDESOLUTION;SUBCUTANEOUS30MG/2.4ML (12.5MG/ML)YesYes
022ZEPBOUND KWIKPENTIRZEPATIDESOLUTION;SUBCUTANEOUS40MG/2.4ML (16.7MG/ML)YesYes
023ZEPBOUND KWIKPENTIRZEPATIDESOLUTION;SUBCUTANEOUS50MG/2.4ML (20.8MG/ML)YesYes
024ZEPBOUND KWIKPENTIRZEPATIDESOLUTION;SUBCUTANEOUS60MG/2.4ML (25MG/ML)YesYes

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
85860SUPPL 2026-05-11
85191SUPPL 2026-03-02
85180SUPPL 2026-02-27
84796SUPPL 2026-01-21
84795SUPPL 2026-01-21
84791SUPPL 2026-01-21
84790SUPPL 2026-01-21
84724SUPPL 2026-01-08
84723SUPPL 2026-01-08
84715SUPPL 2026-01-08
83555SUPPL 2025-09-26
83542SUPPL 2025-09-26
81191SUPPL 2025-02-10
81181SUPPL 2025-02-10
80713SUPPL 2024-12-26
80675SUPPL 2024-12-20
80674SUPPL 2024-12-20
79952SUPPL 2024-10-21
79938SUPPL 2024-10-21
79937SUPPL 2024-10-21
79936SUPPL 2024-10-21
79935SUPPL 2024-10-21
79930SUPPL 2024-10-21
79929SUPPL 2024-10-21
79928SUPPL 2024-10-21
79927SUPPL 2024-10-21
79926SUPPL 2024-10-21
79925SUPPL 2024-10-21
78149ORIG 2024-04-16
78043SUPPL 2024-04-03
78015SUPPL 2024-04-01
76547ORIG 2023-11-13
76538ORIG 2023-11-08