Application 209356

Type: ANDA
Sponsor: AMNEAL PHARMS LLC

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 42.

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
A209356-001	SUCRALFATE	SUCRALFATE	1GM/10ML	SUSPENSION / ORAL	AB		2019-12-02

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A209356-001	AB

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	A209356-001	SUCRALFATE	1GM/10ML	SUSPENSION / ORAL	AB	2019-12-02	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209356-001	SUCRALFATE	1GM/10ML	SUSPENSION / ORAL	AB	2019-12-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209356-001	SUCRALFATE	1GM/10ML	SUSPENSION / ORAL	AB	2019-12-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209356-001	SUCRALFATE	1GM/10ML	SUSPENSION / ORAL	AB	2019-12-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209356-001	SUCRALFATE	1GM/10ML	SUSPENSION / ORAL	AB	2019-12-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209356-001	SUCRALFATE	1GM/10ML	SUSPENSION / ORAL	AB	2019-12-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209356-001	SUCRALFATE	1GM/10ML	SUSPENSION / ORAL	AB	2019-12-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209356-001	SUCRALFATE	1GM/10ML	SUSPENSION / ORAL	AB	2019-12-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209356-001	SUCRALFATE	1GM/10ML	SUSPENSION / ORAL	AB	2019-12-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209356-001	SUCRALFATE	1GM/10ML	SUSPENSION / ORAL	AB	2019-12-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209356-001	SUCRALFATE	1GM/10ML	SUSPENSION / ORAL	AB	2019-12-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209356-001	SUCRALFATE	1GM/10ML	SUSPENSION / ORAL	AB	2019-12-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209356-001	SUCRALFATE	1GM/10ML	SUSPENSION / ORAL	AB	2019-12-02	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209356-001	SUCRALFATE	1GM/10ML	SUSPENSION / ORAL	AB	2019-12-02	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209356-001	SUCRALFATE	1GM/10ML	SUSPENSION / ORAL	AB	2019-12-02	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209356-001	SUCRALFATE	1GM/10ML	SUSPENSION / ORAL	AB	2019-12-02	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209356-001	SUCRALFATE	1GM/10ML	SUSPENSION / ORAL	AB	2019-12-02	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209356-001	SUCRALFATE	1GM/10ML	SUSPENSION / ORAL	AB	2019-12-02	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A209356-001	SUCRALFATE	1GM/10ML	SUSPENSION / ORAL	AB	2019-12-02	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209356-001	SUCRALFATE	1GM/10ML	SUSPENSION / ORAL	AB	2019-12-02	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209356-001	SUCRALFATE	1GM/10ML	SUSPENSION / ORAL	AB	2019-12-02	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209356-001	SUCRALFATE	1GM/10ML	SUSPENSION / ORAL	AB	2019-12-02	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209356-001	SUCRALFATE	1GM/10ML	SUSPENSION / ORAL	AB	2019-12-02	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209356-001	SUCRALFATE	1GM/10ML	SUSPENSION / ORAL	AB	2019-12-02	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A209356-001	SUCRALFATE	1GM/10ML	SUSPENSION / ORAL	AB	2019-12-02	`3f01610625f2…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209356-001	SUCRALFATE	1GM/10ML	SUSPENSION / ORAL	AB	2019-12-02	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209356-001	SUCRALFATE	1GM/10ML	SUSPENSION / ORAL	AB	2019-12-02	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209356-001	SUCRALFATE	1GM/10ML	SUSPENSION / ORAL	AB	2019-12-02	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209356-001	SUCRALFATE	1GM/10ML	SUSPENSION / ORAL	AB	2019-12-02	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209356-001	SUCRALFATE	1GM/10ML	SUSPENSION / ORAL	AB	2019-12-02	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209356-001	SUCRALFATE	1GM/10ML	SUSPENSION / ORAL	AB	2019-12-02	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209356-001	SUCRALFATE	1GM/10ML	SUSPENSION / ORAL	AB	2019-12-02	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209356-001	SUCRALFATE	1GM/10ML	SUSPENSION / ORAL	AB	2019-12-02	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A209356-001	SUCRALFATE	1GM/10ML	SUSPENSION / ORAL	AB	2019-12-02	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209356-001	SUCRALFATE	1GM/10ML	SUSPENSION / ORAL	AB	2019-12-02	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A209356-001	SUCRALFATE	1GM/10ML	SUSPENSION / ORAL	AB	2019-12-02	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A209356-001	SUCRALFATE	1GM/10ML	SUSPENSION / ORAL	AB	2019-12-02	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A209356-001	SUCRALFATE	1GM/10ML	SUSPENSION / ORAL	AB	2019-12-02	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A209356-001	SUCRALFATE	1GM/10ML	SUSPENSION / ORAL	AB	2019-12-02	`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	A209356-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209356-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209356-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209356-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209356-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209356-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209356-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209356-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209356-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209356-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209356-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209356-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209356-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209356-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209356-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209356-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209356-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209356-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A209356-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209356-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209356-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209356-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209356-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209356-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A209356-001	AB	1	`3f01610625f2…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209356-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209356-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209356-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209356-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209356-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209356-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209356-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209356-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A209356-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209356-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A209356-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A209356-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A209356-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A209356-001	AB	1	`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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sucralfate	SUCRALFATE ORAL	Cardinal Health 107, LLC	a0c9f585-1007-4996-aef7-e17cd55d28cd	2025-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209356 application number: ANDA209356
Sucralfate	SUCRALFATE ORAL	AvKARE	c019bf24-8273-8d2f-e053-2a95a90aec98	2025-12-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209356 application number: ANDA209356 ndc (product): 42291-781
Sucralfate	SUCRALFATE ORAL	AvPAK	e78ef7d4-faa7-aebf-e053-2995a90a6f84	2025-12-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209356 application number: ANDA209356 ndc (product): 50268-745
Sucralfate	SUCRALFATE ORAL	Precision Dose, Inc.	0dc592e9-541c-4fac-8ab5-829d43521c01	2025-01-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209356 application number: ANDA209356
Sucralfate	SUCRALFATE ORAL	Amneal Pharmaceuticals LLC	4350b771-76a9-4e00-93f0-a18c71288f83	2024-10-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209356 application number: ANDA209356 ndc (product): 65162-062

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 13 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
17856-0062	Sucralfate	Sucralfate Oral	ATLANTIC BIOLOGICALS CORP.	ANDA	Current
17856-0062	Sucralfate	Sucralfate Oral	ATLANTIC BIOLOGICALS CORP.	ANDA	Current
42291-781	Sucralfate	Sucralfate Oral	AvKARE	ANDA	Current
42291-781	Sucralfate	Sucralfate Oral	AvKARE	ANDA	Current
50268-732	Sucralfate	Sucralfate Oral	AvPAK	ANDA	Current
50268-732	Sucralfate	Sucralfate Oral	AvPAK	ANDA	Current
50268-745	Sucralfate	Sucralfate Oral	AvPAK	ANDA	Current
50268-745	Sucralfate	Sucralfate Oral	AvPAK	ANDA	Current
65162-062	Sucralfate	Sucralfate Oral	Amneal Pharmaceuticals LLC	ANDA	Current
65162-062	Sucralfate	Sucralfate Oral	Amneal Pharmaceuticals LLC	ANDA	Current
65162-062	Sucralfate	Sucralfate Oral	Amneal Pharmaceuticals LLC	ANDA	Current
65162-062	Sucralfate	Sucralfate Oral	Amneal Pharmaceuticals LLC	ANDA	Current
65162-062	Sucralfate	Sucralfate Oral	Amneal Pharmaceuticals LLC	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
61135	ORIG	2020-03-17
62330	ORIG	2019-12-02