Application 220934

Type: NDA
Sponsor: ELI LILLY AND CO

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	FOUNDAYO	ORFORGLIPRON CALCIUM	TABLET;ORAL	EQ 0.8MG BASE	Yes	No
002	FOUNDAYO	ORFORGLIPRON CALCIUM	TABLET;ORAL	EQ 2.5MG BASE	Yes	No
003	FOUNDAYO	ORFORGLIPRON CALCIUM	TABLET;ORAL	EQ 5.5MG BASE	Yes	No
004	FOUNDAYO	ORFORGLIPRON CALCIUM	TABLET;ORAL	EQ 9MG BASE	Yes	No
005	FOUNDAYO	ORFORGLIPRON CALCIUM	TABLET;ORAL	EQ 14.5MG BASE	Yes	No
006	FOUNDAYO	ORFORGLIPRON CALCIUM	TABLET;ORAL	EQ 17.2MG BASE	Yes	Yes

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

Orange Book products#

Current product rows page 1 of 1 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N220934-001	FOUNDAYO	ORFORGLIPRON CALCIUM	EQ 0.8MG BASE	TABLET / ORAL	RLD	2026-04-01
N220934-002	FOUNDAYO	ORFORGLIPRON CALCIUM	EQ 2.5MG BASE	TABLET / ORAL	RLD	2026-04-01
N220934-003	FOUNDAYO	ORFORGLIPRON CALCIUM	EQ 5.5MG BASE	TABLET / ORAL	RLD	2026-04-01
N220934-004	FOUNDAYO	ORFORGLIPRON CALCIUM	EQ 9MG BASE	TABLET / ORAL	RLD	2026-04-01
N220934-005	FOUNDAYO	ORFORGLIPRON CALCIUM	EQ 14.5MG BASE	TABLET / ORAL	RLD	2026-04-01
N220934-006	FOUNDAYO	ORFORGLIPRON CALCIUM	EQ 17.2MG BASE	TABLET / ORAL	RLD, RS	2026-04-01

Orange Book patents#

Current patent rows page 1 of 1 · 6 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N220934-001	RE50455	2037-09-26	U-4474	Drug substance, Drug product	2026-04-14
N220934-002	RE50455	2037-09-26	U-4474	Drug substance, Drug product	2026-04-14
N220934-003	RE50455	2037-09-26	U-4474	Drug substance, Drug product	2026-04-14
N220934-004	RE50455	2037-09-26	U-4474	Drug substance, Drug product	2026-04-14
N220934-005	RE50455	2037-09-26	U-4474	Drug substance, Drug product	2026-04-14
N220934-006	RE50455	2037-09-26	U-4474	Drug substance, Drug product	2026-04-14

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 6 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N220934-001	NCE	2031-04-01
N220934-002	NCE	2031-04-01
N220934-003	NCE	2031-04-01
N220934-004	NCE	2031-04-01
N220934-005	NCE	2031-04-01
N220934-006	NCE	2031-04-01

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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N220934-001	FOUNDAYO	EQ 0.8MG BASE	TABLET / ORAL	RLD	2026-04-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N220934-002	FOUNDAYO	EQ 2.5MG BASE	TABLET / ORAL	RLD	2026-04-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N220934-003	FOUNDAYO	EQ 5.5MG BASE	TABLET / ORAL	RLD	2026-04-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N220934-004	FOUNDAYO	EQ 9MG BASE	TABLET / ORAL	RLD	2026-04-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N220934-005	FOUNDAYO	EQ 14.5MG BASE	TABLET / ORAL	RLD	2026-04-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N220934-006	FOUNDAYO	EQ 17.2MG BASE	TABLET / ORAL	RLD, RS	2026-04-01	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N220934-001	FOUNDAYO	EQ 0.8MG BASE	TABLET / ORAL	RLD	2026-04-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N220934-002	FOUNDAYO	EQ 2.5MG BASE	TABLET / ORAL	RLD	2026-04-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N220934-003	FOUNDAYO	EQ 5.5MG BASE	TABLET / ORAL	RLD	2026-04-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N220934-004	FOUNDAYO	EQ 9MG BASE	TABLET / ORAL	RLD	2026-04-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N220934-005	FOUNDAYO	EQ 14.5MG BASE	TABLET / ORAL	RLD	2026-04-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N220934-006	FOUNDAYO	EQ 17.2MG BASE	TABLET / ORAL	RLD, RS	2026-04-01	`caaa826d4ba7…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N220934-001	FOUNDAYO	EQ 0.8MG BASE	TABLET / ORAL	RLD	2026-04-01	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N220934-002	FOUNDAYO	EQ 2.5MG BASE	TABLET / ORAL	RLD	2026-04-01	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N220934-003	FOUNDAYO	EQ 5.5MG BASE	TABLET / ORAL	RLD	2026-04-01	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N220934-004	FOUNDAYO	EQ 9MG BASE	TABLET / ORAL	RLD	2026-04-01	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N220934-005	FOUNDAYO	EQ 14.5MG BASE	TABLET / ORAL	RLD	2026-04-01	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N220934-006	FOUNDAYO	EQ 17.2MG BASE	TABLET / ORAL	RLD, RS	2026-04-01	`a50c72e98297…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-09-14 22:38:34	2026-08	N220934-001	RE50455	2037-09-26	U-4474	Drug substance, Drug product	2026-04-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N220934-002	RE50455	2037-09-26	U-4474	Drug substance, Drug product	2026-04-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N220934-003	RE50455	2037-09-26	U-4474	Drug substance, Drug product	2026-04-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N220934-004	RE50455	2037-09-26	U-4474	Drug substance, Drug product	2026-04-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N220934-005	RE50455	2037-09-26	U-4474	Drug substance, Drug product	2026-04-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N220934-006	RE50455	2037-09-26	U-4474	Drug substance, Drug product	2026-04-14	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N220934-001	RE50455	2037-09-26	U-4474	Drug substance, Drug product	2026-04-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N220934-002	RE50455	2037-09-26	U-4474	Drug substance, Drug product	2026-04-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N220934-003	RE50455	2037-09-26	U-4474	Drug substance, Drug product	2026-04-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N220934-004	RE50455	2037-09-26	U-4474	Drug substance, Drug product	2026-04-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N220934-005	RE50455	2037-09-26	U-4474	Drug substance, Drug product	2026-04-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N220934-006	RE50455	2037-09-26	U-4474	Drug substance, Drug product	2026-04-14	`caaa826d4ba7…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N220934-001	RE50455	2037-09-26	U-4474	Drug substance, Drug product	2026-04-14	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N220934-002	RE50455	2037-09-26	U-4474	Drug substance, Drug product	2026-04-14	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N220934-003	RE50455	2037-09-26	U-4474	Drug substance, Drug product	2026-04-14	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N220934-004	RE50455	2037-09-26	U-4474	Drug substance, Drug product	2026-04-14	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N220934-005	RE50455	2037-09-26	U-4474	Drug substance, Drug product	2026-04-14	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N220934-006	RE50455	2037-09-26	U-4474	Drug substance, Drug product	2026-04-14	`a50c72e98297…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-09-14 22:38:34	2026-08	N220934-001	NCE	2031-04-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N220934-002	NCE	2031-04-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N220934-003	NCE	2031-04-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N220934-004	NCE	2031-04-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N220934-005	NCE	2031-04-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N220934-006	NCE	2031-04-01	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N220934-001	NCE	2031-04-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N220934-002	NCE	2031-04-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N220934-003	NCE	2031-04-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N220934-004	NCE	2031-04-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N220934-005	NCE	2031-04-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N220934-006	NCE	2031-04-01	`caaa826d4ba7…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N220934-001	NCE	2031-04-01	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N220934-002	NCE	2031-04-01	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N220934-003	NCE	2031-04-01	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N220934-004	NCE	2031-04-01	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N220934-005	NCE	2031-04-01	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N220934-006	NCE	2031-04-01	`a50c72e98297…`

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
FOUNDAYO	ORFORGLIPRON	Eli Lilly and Company	8ac446c5-feba-474f-a103-23facb9b5c62	2026-07-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 220934 application number: NDA220934

Reported adverse events (FAERS/openFDA)#

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

Documents#

Document, Submission type, Date table
Document	Submission type	Date
85914	ORIG	2026-05-15
85636	ORIG	2026-04-02
85635	ORIG	2026-04-02
85664	ORIG	2026-04-01