Application 208977

Type: ANDA
Sponsor: INTL MEDICATION SYS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	IRON SUCROSE	IRON SUCROSE	INJECTABLE;INTRAVENOUS	EQ 50MG IRON/2.5ML (EQ 20MG IRON/ML)	No	No
002	IRON SUCROSE	IRON SUCROSE	INJECTABLE;INTRAVENOUS	EQ 100MG IRON/5ML (EQ 20MG IRON/ML)	No	No
003	IRON SUCROSE	IRON SUCROSE	INJECTABLE;INTRAVENOUS	EQ 200MG IRON/10ML (EQ 20MG IRON/ML)	No	No

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A208977-001	IRON SUCROSE	IRON SUCROSE	EQ 50MG IRON/2.5ML (EQ 20MG IRON/ML)	INJECTABLE / INTRAVENOUS	AB	2025-08-08
A208977-002	IRON SUCROSE	IRON SUCROSE	EQ 100MG IRON/5ML (EQ 20MG IRON/ML)	INJECTABLE / INTRAVENOUS	AB	2025-08-08
A208977-003	IRON SUCROSE	IRON SUCROSE	EQ 200MG IRON/10ML (EQ 20MG IRON/ML)	INJECTABLE / INTRAVENOUS	AB	2025-08-08

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A208977-001	AB
A208977-002	AB
A208977-003	AB

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
A208977-001	CGT	2026-02-08

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	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A208977-001	IRON SUCROSE	EQ 50MG IRON/2.5ML (EQ 20MG IRON/ML)	INJECTABLE / INTRAVENOUS	AB	2025-08-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208977-002	IRON SUCROSE	EQ 100MG IRON/5ML (EQ 20MG IRON/ML)	INJECTABLE / INTRAVENOUS	AB	2025-08-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208977-003	IRON SUCROSE	EQ 200MG IRON/10ML (EQ 20MG IRON/ML)	INJECTABLE / INTRAVENOUS	AB	2025-08-08	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208977-001	IRON SUCROSE	EQ 50MG IRON/2.5ML (EQ 20MG IRON/ML)	INJECTABLE / INTRAVENOUS	AB	2025-08-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208977-002	IRON SUCROSE	EQ 100MG IRON/5ML (EQ 20MG IRON/ML)	INJECTABLE / INTRAVENOUS	AB	2025-08-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208977-003	IRON SUCROSE	EQ 200MG IRON/10ML (EQ 20MG IRON/ML)	INJECTABLE / INTRAVENOUS	AB	2025-08-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208977-001	IRON SUCROSE	EQ 50MG IRON/2.5ML (EQ 20MG IRON/ML)	INJECTABLE / INTRAVENOUS	AB	2025-08-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208977-002	IRON SUCROSE	EQ 100MG IRON/5ML (EQ 20MG IRON/ML)	INJECTABLE / INTRAVENOUS	AB	2025-08-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208977-003	IRON SUCROSE	EQ 200MG IRON/10ML (EQ 20MG IRON/ML)	INJECTABLE / INTRAVENOUS	AB	2025-08-08	`31067a03dcf5…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A208977-001	IRON SUCROSE	EQ 50MG IRON/2.5ML (EQ 20MG IRON/ML)	INJECTABLE / INTRAVENOUS	AB	2025-08-08	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A208977-002	IRON SUCROSE	EQ 100MG IRON/5ML (EQ 20MG IRON/ML)	INJECTABLE / INTRAVENOUS	AB	2025-08-08	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A208977-003	IRON SUCROSE	EQ 200MG IRON/10ML (EQ 20MG IRON/ML)	INJECTABLE / INTRAVENOUS	AB	2025-08-08	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A208977-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208977-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208977-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208977-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208977-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208977-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208977-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208977-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208977-003	AB	1	`31067a03dcf5…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A208977-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A208977-002	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A208977-003	AB	1	`a50c72e98297…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-08-18 06:07:40	2026-07	A208977-001	CGT	2026-02-08	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208977-001	CGT	2026-02-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208977-001	CGT	2026-02-08	`31067a03dcf5…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A208977-001	CGT	2026-02-08	`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
Iron Sucrose	IRON SUCROSE	International Medication Systems, Limited	6f19c80e-22e9-4bab-aa53-4d2d958119ed	2026-06-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208977 application number: ANDA208977