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 3 of 4 · 70 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sucralfate	SUCRALFATE	NuCare Pharmaceuticals,Inc.	0206d7fa-a1d5-35d9-e063-6294a90a5eb3	2025-01-03	Adverse reactions	Name fallback brand name: Sucralfate generic name: SUCRALFATE
Sucralfate	SUCRALFATE	Advanced Rx of Tennessee, LLC	b39f22c8-f224-451a-e053-2995a90aaad7	2024-12-31	Adverse reactions	Name fallback brand name: Sucralfate generic name: SUCRALFATE
Sucralfate	SUCRALFATE	Advanced Rx Pharmacy of Tennessee, LLC	d3c41720-7e1a-08c1-e053-2a95a90aba03	2024-12-31	Adverse reactions	Name fallback brand name: Sucralfate generic name: SUCRALFATE
Sucralfate	SUCRALFATE	Advanced Rx Pharmacy of Tennessee, LLC	f15fbb45-4406-0d32-e053-2995a90a40c5	2024-12-31	Adverse reactions	Name fallback brand name: Sucralfate generic name: SUCRALFATE
Sucralfate	SUCRALFATE	Cosette Pharmaceuticals, Inc.	3054ce94-78a2-4da4-8b14-95311b412ab2	2024-11-25	Warnings, Adverse reactions	Name fallback brand name: Sucralfate generic name: SUCRALFATE
Sucralfate	SUCRALFATE ORAL	Amneal Pharmaceuticals LLC	4350b771-76a9-4e00-93f0-a18c71288f83	2024-10-30	Warnings, Adverse reactions	Name fallback brand name: Sucralfate
Sucralfate	SUCRALFATE	Bryant Ranch Prepack	a068e818-8da3-4f0d-88e0-acc88e76f3aa	2024-08-22	Adverse reactions	Name fallback brand name: Sucralfate generic name: SUCRALFATE
Sucralfate	SUCRALFATE	NuCare Pharmaceuticals,Inc.	a40e43d4-9240-34ad-e053-2995a90a98e1	2024-07-15	Adverse reactions	Name fallback brand name: Sucralfate generic name: SUCRALFATE
Carafate	SUCRALFATE	Allergan, Inc.	c87c6b50-6977-4fa7-ae98-40c0753f7aee	2024-05-21	Adverse reactions	Name fallback generic name: SUCRALFATE
Sucralfate	SUCRALFATE	Proficient Rx LP	51459cdb-a04a-49c2-8ee4-8f234f522476	2024-05-01	Adverse reactions	Name fallback brand name: Sucralfate generic name: SUCRALFATE
Sucralfate	SUCRALFATE	Golden State Medical Supply, Inc.	15ad28fa-81ac-66d1-e063-6394a90aa3ea	2024-04-09	Adverse reactions	Name fallback brand name: Sucralfate generic name: SUCRALFATE
Sucralfate	SUCRALFATE	Advanced Rx Pharmacy of Tennessee, LLC	138f0929-caad-56c6-e063-6294a90a55ef	2024-03-13	Adverse reactions	Name fallback brand name: Sucralfate generic name: SUCRALFATE
Sucralfate	SUCRALFATE	Amneal Pharmaceuticals NY LLC	b2e07ac7-4a8a-4b68-bb65-167d1aa86883	2024-03-01	Adverse reactions	Name fallback brand name: Sucralfate generic name: SUCRALFATE
Sucralfate	SUCRALFATE	Bryant Ranch Prepack	28d7d257-8545-4b9f-8412-8ba144502400	2024-02-23	Adverse reactions	Name fallback brand name: Sucralfate generic name: SUCRALFATE
Sucralfate	SUCRALFATE	Pacific Pharma, Inc.	7407c58e-766f-4e93-a1bb-c77892ae0174	2024-02-10	Warnings, Adverse reactions	Name fallback brand name: Sucralfate generic name: SUCRALFATE
Sucralfate	SUCRALFATE	Bryant Ranch Prepack	7b05323d-4695-41d7-8236-1e7b4e8f2a1e	2024-01-11	Adverse reactions	Name fallback brand name: Sucralfate generic name: SUCRALFATE
Sucralfate	SUCRALFATE	Bryant Ranch Prepack	25ae2ebc-a7e0-4fc9-a8d1-07f7dd7138e5	2024-01-11	Adverse reactions	Name fallback brand name: Sucralfate generic name: SUCRALFATE
Sucralfate	SUCRALFATE	Proficient Rx LP	a42c5f3d-85f1-485b-91e6-58c25b3ddc71	2024-01-01	Adverse reactions	Name fallback brand name: Sucralfate generic name: SUCRALFATE
Sucralfate	SUCRALFATE	Amneal Pharmaceuticals NY LLC	a4f722e7-2885-4f27-8358-9c662439600a	2023-12-30	Adverse reactions	Name fallback brand name: Sucralfate generic name: SUCRALFATE
Sucralfate	SUCRALFATE	American Health Packaging	e4761fb2-6a1a-44de-9d27-f6addabc24c8	2023-08-10	Warnings, 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.