Application 215576

Type: ANDA
Sponsor: AMNEAL PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	SUCRALFATE	SUCRALFATE	TABLET;ORAL	1GM	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A215576-001	SUCRALFATE	SUCRALFATE	1GM	TABLET / ORAL	AB		2022-04-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A215576-001	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
2026-02-19 14:30 UTC	2026-02	A215576-001	SUCRALFATE	1GM	TABLET / ORAL	AB	2022-04-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215576-001	SUCRALFATE	1GM	TABLET / ORAL	AB	2022-04-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215576-001	SUCRALFATE	1GM	TABLET / ORAL	AB	2022-04-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215576-001	SUCRALFATE	1GM	TABLET / ORAL	AB	2022-04-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215576-001	SUCRALFATE	1GM	TABLET / ORAL	AB	2022-04-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215576-001	SUCRALFATE	1GM	TABLET / ORAL	AB	2022-04-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215576-001	SUCRALFATE	1GM	TABLET / ORAL	AB	2022-04-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215576-001	SUCRALFATE	1GM	TABLET / ORAL	AB	2022-04-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215576-001	SUCRALFATE	1GM	TABLET / ORAL	AB	2022-04-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215576-001	SUCRALFATE	1GM	TABLET / ORAL	AB	2022-04-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215576-001	SUCRALFATE	1GM	TABLET / ORAL	AB	2022-04-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215576-001	SUCRALFATE	1GM	TABLET / ORAL	AB	2022-04-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215576-001	SUCRALFATE	1GM	TABLET / ORAL	AB	2022-04-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A215576-001	SUCRALFATE	1GM	TABLET / ORAL	AB	2022-04-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A215576-001	SUCRALFATE	1GM	TABLET / ORAL	AB	2022-04-15	`5c6f7cd8ea54…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A215576-001	SUCRALFATE	1GM	TABLET / ORAL	AB	2022-04-15	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A215576-001	SUCRALFATE	1GM	TABLET / ORAL	AB	2022-04-15	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A215576-001	SUCRALFATE	1GM	TABLET / ORAL	AB	2022-04-15	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A215576-001	SUCRALFATE	1GM	TABLET / ORAL	AB	2022-04-15	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A215576-001	SUCRALFATE	1GM	TABLET / ORAL	AB	2022-04-15	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A215576-001	SUCRALFATE	1GM	TABLET / ORAL	AB	2022-04-15	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A215576-001	SUCRALFATE	1GM	TABLET / ORAL	AB	2022-04-15	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A215576-001	SUCRALFATE	1GM	TABLET / ORAL	AB	2022-04-15	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A215576-001	SUCRALFATE	1GM	TABLET / ORAL	AB	2022-04-15	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A215576-001	SUCRALFATE	1GM	TABLET / ORAL	AB	2022-04-15	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A215576-001	SUCRALFATE	1GM	TABLET / ORAL	AB	2022-04-15	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A215576-001	SUCRALFATE	1GM	TABLET / ORAL	AB	2022-04-15	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A215576-001	SUCRALFATE	1GM	TABLET / ORAL	AB	2022-04-15	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A215576-001	SUCRALFATE	1GM	TABLET / ORAL	AB	2022-04-15	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A215576-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215576-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215576-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215576-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215576-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215576-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215576-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215576-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215576-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215576-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215576-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215576-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215576-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A215576-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A215576-001	AB	1	`5c6f7cd8ea54…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A215576-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A215576-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A215576-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A215576-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A215576-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A215576-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A215576-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A215576-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A215576-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A215576-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A215576-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A215576-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A215576-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A215576-001	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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sucralfate	SUCRALFATE	AvKARE	0909acc5-c746-17fb-e063-6394a90a677f	2026-01-19	Adverse reactions	Exact identifier application applno (ANDA): 215576 application number: ANDA215576
Sucralfate	SUCRALFATE	Amneal Pharmaceuticals NY LLC	b2e07ac7-4a8a-4b68-bb65-167d1aa86883	2024-03-01	Adverse reactions	Exact identifier application applno (ANDA): 215576 application number: ANDA215576
Sucralfate	SUCRALFATE	Amneal Pharmaceuticals NY LLC	a4f722e7-2885-4f27-8358-9c662439600a	2023-12-30	Adverse reactions	Exact identifier application applno (ANDA): 215576 application number: ANDA215576 ndc (product): 69238-1656

NDC Listings For This Application#

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

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
69238-1656	Sucralfate	Sucralfate	Amneal Pharmaceuticals NY LLC	ANDA	Current