Application 212769

Type: ANDA
Sponsor: HIKMA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	SUCRALFATE	SUCRALFATE	SUSPENSION;ORAL	1GM/10ML	No	No

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A212769-001	SUCRALFATE	SUCRALFATE	1GM/10ML	SUSPENSION / ORAL			2024-07-23

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
2026-09-14 22:38:34	2026-08	A212769-001	SUCRALFATE	1GM/10ML	SUSPENSION / ORAL		2024-07-23	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A212769-001	SUCRALFATE	1GM/10ML	SUSPENSION / ORAL		2024-07-23	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212769-001	SUCRALFATE	1GM/10ML	SUSPENSION / ORAL		2024-07-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212769-001	SUCRALFATE	1GM/10ML	SUSPENSION / ORAL		2024-07-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212769-001	SUCRALFATE	1GM/10ML	SUSPENSION / ORAL		2024-07-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212769-001	SUCRALFATE	1GM/10ML	SUSPENSION / ORAL		2024-07-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212769-001	SUCRALFATE	1GM/10ML	SUSPENSION / ORAL		2024-07-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212769-001	SUCRALFATE	1GM/10ML	SUSPENSION / ORAL		2024-07-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212769-001	SUCRALFATE	1GM/10ML	SUSPENSION / ORAL	AB	2024-07-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212769-001	SUCRALFATE	1GM/10ML	SUSPENSION / ORAL	AB	2024-07-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212769-001	SUCRALFATE	1GM/10ML	SUSPENSION / ORAL	AB	2024-07-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212769-001	SUCRALFATE	1GM/10ML	SUSPENSION / ORAL	AB	2024-07-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212769-001	SUCRALFATE	1GM/10ML	SUSPENSION / ORAL	AB	2024-07-23	`79d66fd596c7…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A212769-001	SUCRALFATE	1GM/10ML	SUSPENSION / ORAL		2024-07-23	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212769-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212769-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212769-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212769-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212769-001	AB	1	`79d66fd596c7…`

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 4 of 4 · 70 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sucralfate	SUCRALFATE	A-S Medication Solutions	793d033d-d341-4910-8dda-d43d8fd03a4d	2023-06-29	Adverse reactions	Name fallback brand name: Sucralfate generic name: SUCRALFATE
Carafate	SUCRALFATE	Allergan, Inc.	0fb67b1c-b4c0-46f2-8a81-df1510e006aa	2023-06-08	Warnings, Adverse reactions	Name fallback generic name: SUCRALFATE
Sucralfate	SUCRALFATE	Bryant Ranch Prepack	2687d670-8af6-42a2-9081-fee112e80fc0	2023-05-24	Adverse reactions	Name fallback brand name: Sucralfate generic name: SUCRALFATE
Sucralfate	SUCRALFATE	Bryant Ranch Prepack	370f5ac6-2c64-42ef-ab5d-075a473012f1	2023-05-22	Adverse reactions	Name fallback brand name: Sucralfate generic name: SUCRALFATE
Sucralfate	SUCRALFATE	A-S Medication Solutions	03b66f88-d346-4260-867c-c942c4c68a79	2023-05-02	Adverse reactions	Name fallback brand name: Sucralfate generic name: SUCRALFATE
Sucralfate	SUCRALFATE	Aphena Pharma Solutions - Tennessee, LLC	b414dc07-681c-4fde-965f-09df64c015e7	2021-05-19	Adverse reactions	Name fallback brand name: Sucralfate generic name: SUCRALFATE
Sucralfate	SUCRALFATE	Mylan Pharmaceuticals, Inc.	ae58c382-c1cf-4ebf-9c97-bdff0682df8b	2020-06-12	Adverse reactions	Name fallback brand name: Sucralfate generic name: SUCRALFATE
sucralfate	SUCRALFATE	Mylan Pharmaceuticals Inc.	1e781cc0-24ec-4028-8262-dcef9873ea1f	2020-01-14	Warnings, Adverse reactions	Name fallback brand name: sucralfate generic name: SUCRALFATE
Sucralfate	SUCRALFATE	Aphena Pharma Solutions - Tennessee, LLC	84447e21-e311-4e9f-9065-53956e90135c	2019-04-22	Adverse reactions	Name fallback brand name: Sucralfate generic name: SUCRALFATE
Sucralfate	SUCRALFATE	Teva Pharmaceuticals USA, Inc.	c7a43df7-eb37-4273-9250-87953b1fd270	2015-09-01	Adverse reactions	Name fallback brand name: Sucralfate generic name: SUCRALFATE

Reported adverse events (FAERS/openFDA)#

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