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 2 of 4 · 70 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sucralfate	SUCRALFATE	Northwind Health Company, LLC	f3095db3-fd02-873c-e053-2a95a90a5b1f	2026-01-01	Adverse reactions	Name fallback brand name: Sucralfate generic name: SUCRALFATE
Sucralfate	SUCRALFATE ORAL	Cardinal Health 107, LLC	a0c9f585-1007-4996-aef7-e17cd55d28cd	2025-12-31	Warnings, Adverse reactions	Name fallback brand name: Sucralfate
Sucralfate	SUCRALFATE ORAL	TruPharma, LLC	7d441128-45d2-4bf2-817b-665784992e90	2025-12-29	Warnings, Adverse reactions	Name fallback brand name: Sucralfate
Sucralfate	SUCRALFATE	Northwind Health Company, LLC	464bf611-4dbb-4707-b9dd-39ca178ed4bf	2025-12-26	Adverse reactions	Name fallback brand name: Sucralfate generic name: SUCRALFATE
Sucralfate	SUCRALFATE	Redpharm Drug	3251e156-4c52-63b3-e063-6294a90a9a95	2025-12-18	Adverse reactions	Name fallback brand name: Sucralfate generic name: SUCRALFATE
Sucralfate	SUCRALFATE ORAL	AvKARE	c019bf24-8273-8d2f-e053-2a95a90aec98	2025-12-03	Warnings, Adverse reactions	Name fallback brand name: Sucralfate
Sucralfate	SUCRALFATE ORAL	AvPAK	e78ef7d4-faa7-aebf-e053-2995a90a6f84	2025-12-03	Warnings, Adverse reactions	Name fallback brand name: Sucralfate
Sucralfate	SUCRALFATE	Torrent Pharmaceuticals Limited	dc361b46-fda4-4b0b-9950-e8885ba5b084	2025-08-21	Warnings, Adverse reactions	Name fallback brand name: Sucralfate generic name: SUCRALFATE
Sucralfate	SUCRALFATE	Mylan Institutional Inc.	989ca8a8-3ad6-4ee4-aa9c-eed731828753	2025-07-22	Adverse reactions	Name fallback brand name: Sucralfate generic name: SUCRALFATE
Sucralfate	SUCRALFATE	Kesin Pharma Corporation	36d940f2-207b-68c5-e063-6294a90a6b4a	2025-07-01	Warnings, Adverse reactions	Name fallback brand name: Sucralfate generic name: SUCRALFATE
Sucralfate	SUCRALFATE	NCS HealthCare of KY, LLC dba Vangard Labs	d67dcaad-56c1-4e77-a0c8-655970808414	2025-06-13	Adverse reactions	Name fallback brand name: Sucralfate generic name: SUCRALFATE
Sucralfate	SUCRALFATE	Bryant Ranch Prepack	a73010fb-960c-4567-8ab1-6d902fee2c14	2025-06-02	Adverse reactions	Name fallback brand name: Sucralfate generic name: SUCRALFATE
Sucralfate	SUCRALFATE	ATLANTIC BIOLOGICALS CORP.	e5073597-ac51-4e7c-a9dc-7695773a01f1	2025-05-27	Warnings, Adverse reactions	Name fallback brand name: Sucralfate generic name: SUCRALFATE
Sucralfate	SUCRALFATE	Richmond Pharmaceuticals, Inc.	7ac10c3f-9d50-4702-900c-41075ac6f896	2025-05-23	Warnings, Adverse reactions	Name fallback brand name: Sucralfate generic name: SUCRALFATE
sucralfate	SUCRALFATE	Bryant Ranch Prepack	abc44549-ac41-4aef-9b15-2ba536e1555f	2025-05-09	Warnings, Adverse reactions	Name fallback brand name: sucralfate generic name: SUCRALFATE
Sucralfate	SUCRALFATE	NuCare Pharmaceuticals, Inc.	31a7dcd0-e677-249a-e063-6294a90a75f6	2025-03-19	Adverse reactions	Name fallback brand name: Sucralfate generic name: SUCRALFATE
Sucralfate	SUCRALFATE	Coupler LLC	2d586736-73ae-9af0-e063-6294a90ad875	2025-02-04	Adverse reactions	Name fallback brand name: Sucralfate generic name: SUCRALFATE
Sucralfate	SUCRALFATE ORAL	Precision Dose, Inc.	0dc592e9-541c-4fac-8ab5-829d43521c01	2025-01-28	Warnings, Adverse reactions	Name fallback brand name: Sucralfate
Sucralfate	SUCRALFATE	Direct_Rx	f5f0fecb-949c-3998-e053-2a95a90aac8c	2025-01-22	Adverse reactions	Name fallback brand name: Sucralfate generic name: SUCRALFATE
SUCRALFATE	SUCRALFATE	DIRECT RX	c50b5044-31ed-672a-e053-2995a90a49fc	2025-01-20	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.