Application 206697

Type: ANDA
Sponsor: AMNEAL

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	EXENATIDE SYNTHETIC	EXENATIDE SYNTHETIC	INJECTABLE;SUBCUTANEOUS	300MCG/1.2ML (250MCG/ML)	No	Yes
002	EXENATIDE SYNTHETIC	EXENATIDE SYNTHETIC	INJECTABLE;SUBCUTANEOUS	600MCG/2.4ML (250MCG/ML)	No	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A206697-001	EXENATIDE SYNTHETIC	EXENATIDE SYNTHETIC	300MCG/1.2ML (250MCG/ML)	INJECTABLE / SUBCUTANEOUS		RS	2024-11-19
A206697-002	EXENATIDE SYNTHETIC	EXENATIDE SYNTHETIC	600MCG/2.4ML (250MCG/ML)	INJECTABLE / SUBCUTANEOUS		RS	2024-11-19

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	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A206697-001	EXENATIDE SYNTHETIC	300MCG/1.2ML (250MCG/ML)	INJECTABLE / SUBCUTANEOUS		RS	2024-11-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206697-002	EXENATIDE SYNTHETIC	600MCG/2.4ML (250MCG/ML)	INJECTABLE / SUBCUTANEOUS		RS	2024-11-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A206697-001	EXENATIDE SYNTHETIC	300MCG/1.2ML (250MCG/ML)	INJECTABLE / SUBCUTANEOUS		RS	2024-11-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206697-002	EXENATIDE SYNTHETIC	600MCG/2.4ML (250MCG/ML)	INJECTABLE / SUBCUTANEOUS		RS	2024-11-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206697-001	EXENATIDE SYNTHETIC	300MCG/1.2ML (250MCG/ML)	INJECTABLE / SUBCUTANEOUS		RS	2024-11-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206697-002	EXENATIDE SYNTHETIC	600MCG/2.4ML (250MCG/ML)	INJECTABLE / SUBCUTANEOUS		RS	2024-11-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206697-001	EXENATIDE SYNTHETIC	300MCG/1.2ML (250MCG/ML)	INJECTABLE / SUBCUTANEOUS		RS	2024-11-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206697-002	EXENATIDE SYNTHETIC	600MCG/2.4ML (250MCG/ML)	INJECTABLE / SUBCUTANEOUS		RS	2024-11-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206697-001	EXENATIDE SYNTHETIC	300MCG/1.2ML (250MCG/ML)	INJECTABLE / SUBCUTANEOUS	AP		2024-11-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206697-002	EXENATIDE SYNTHETIC	600MCG/2.4ML (250MCG/ML)	INJECTABLE / SUBCUTANEOUS	AP		2024-11-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206697-001	EXENATIDE SYNTHETIC	300MCG/1.2ML (250MCG/ML)	INJECTABLE / SUBCUTANEOUS	AP		2024-11-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206697-002	EXENATIDE SYNTHETIC	600MCG/2.4ML (250MCG/ML)	INJECTABLE / SUBCUTANEOUS	AP		2024-11-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206697-001	EXENATIDE SYNTHETIC	300MCG/1.2ML (250MCG/ML)	INJECTABLE / SUBCUTANEOUS	AP		2024-11-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206697-002	EXENATIDE SYNTHETIC	600MCG/2.4ML (250MCG/ML)	INJECTABLE / SUBCUTANEOUS	AP		2024-11-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206697-001	EXENATIDE SYNTHETIC	300MCG/1.2ML (250MCG/ML)	INJECTABLE / SUBCUTANEOUS	AP		2024-11-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206697-002	EXENATIDE SYNTHETIC	600MCG/2.4ML (250MCG/ML)	INJECTABLE / SUBCUTANEOUS	AP		2024-11-19	`2680178bc6a6…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A206697-001	EXENATIDE SYNTHETIC	300MCG/1.2ML (250MCG/ML)	INJECTABLE / SUBCUTANEOUS		RS	2024-11-19	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A206697-002	EXENATIDE SYNTHETIC	600MCG/2.4ML (250MCG/ML)	INJECTABLE / SUBCUTANEOUS		RS	2024-11-19	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206697-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206697-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206697-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206697-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206697-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206697-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206697-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206697-002	AP	1	`2680178bc6a6…`

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
Exenatide	EXENATIDE	Amneal Pharmaceuticals LLC	e6cb5c8f-e97f-4a6a-95a4-939fd2393949	2026-05-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206697 application number: ANDA206697