Application 018333

Type: NDA
Sponsor: ALLERGAN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CARAFATE	SUCRALFATE	TABLET;ORAL	1GM	Yes	Yes

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
N018333-001	CARAFATE	SUCRALFATE	1GM	TABLET / ORAL	AB	RLD, RS, Approved before 1982

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N018333-001	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.

Product history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Source SHA-256
2026-08-18 06:07:40	2026-07	N018333-001	CARAFATE	1GM	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N018333-001	CARAFATE	1GM	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018333-001	CARAFATE	1GM	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018333-001	CARAFATE	1GM	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018333-001	CARAFATE	1GM	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018333-001	CARAFATE	1GM	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018333-001	CARAFATE	1GM	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018333-001	CARAFATE	1GM	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018333-001	CARAFATE	1GM	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018333-001	CARAFATE	1GM	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N018333-001	CARAFATE	1GM	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018333-001	CARAFATE	1GM	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018333-001	CARAFATE	1GM	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018333-001	CARAFATE	1GM	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N018333-001	CARAFATE	1GM	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018333-001	CARAFATE	1GM	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N018333-001	CARAFATE	1GM	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N018333-001	CARAFATE	1GM	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N018333-001	CARAFATE	1GM	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N018333-001	CARAFATE	1GM	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N018333-001	CARAFATE	1GM	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N018333-001	CARAFATE	1GM	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N018333-001	CARAFATE	1GM	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N018333-001	CARAFATE	1GM	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N018333-001	CARAFATE	1GM	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N018333-001	CARAFATE	1GM	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N018333-001	CARAFATE	1GM	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N018333-001	CARAFATE	1GM	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N018333-001	CARAFATE	1GM	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N018333-001	CARAFATE	1GM	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N018333-001	CARAFATE	1GM	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N018333-001	CARAFATE	1GM	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N018333-001	CARAFATE	1GM	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N018333-001	CARAFATE	1GM	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N018333-001	CARAFATE	1GM	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N018333-001	CARAFATE	1GM	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N018333-001	CARAFATE	1GM	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N018333-001	CARAFATE	1GM	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N018333-001	CARAFATE	1GM	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N018333-001	CARAFATE	1GM	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	N018333-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N018333-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018333-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018333-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018333-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018333-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018333-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018333-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018333-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018333-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N018333-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018333-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018333-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018333-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N018333-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018333-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N018333-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N018333-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N018333-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N018333-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N018333-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N018333-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N018333-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N018333-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N018333-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N018333-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N018333-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N018333-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N018333-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N018333-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N018333-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N018333-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N018333-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N018333-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N018333-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N018333-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N018333-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N018333-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N018333-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N018333-001	AB	1	`e64feba35796…`

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 · 9 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	Exact identifier application applno (NDA): 018333 application number: NDA018333
Sucralfate	SUCRALFATE	Preferred Pharmaceuticals Inc.	536b8c00-13ab-4397-a754-63a1c92bf883	2025-09-24	Adverse reactions	Exact identifier application applno (NDA): 018333 application number: NDA018333 ndc (product): 68788-8316
Sucralfate	SUCRALFATE	Bryant Ranch Prepack	a73010fb-960c-4567-8ab1-6d902fee2c14	2025-06-02	Adverse reactions	Exact identifier application applno (NDA): 018333 application number: NDA018333
Sucralfate	SUCRALFATE	Advanced Rx Pharmacy of Tennessee, LLC	f15fbb45-4406-0d32-e053-2995a90a40c5	2024-12-31	Adverse reactions	Exact identifier application applno (NDA): 018333 application number: NDA018333 ndc (product): 80425-0213
Carafate	SUCRALFATE	Allergan, Inc.	c87c6b50-6977-4fa7-ae98-40c0753f7aee	2024-05-21	Adverse reactions	Exact identifier application applno (NDA): 018333 application number: NDA018333 ndc (product): 58914-171
Sucralfate	SUCRALFATE	Advanced Rx Pharmacy of Tennessee, LLC	138f0929-caad-56c6-e063-6294a90a55ef	2024-03-13	Adverse reactions	Exact identifier application applno (NDA): 018333 application number: NDA018333
Sucralfate	SUCRALFATE	A-S Medication Solutions	793d033d-d341-4910-8dda-d43d8fd03a4d	2023-06-29	Adverse reactions	Exact identifier application applno (NDA): 018333 application number: NDA018333 ndc (product): 50090-5287
Sucralfate	SUCRALFATE	Mylan Pharmaceuticals, Inc.	ae58c382-c1cf-4ebf-9c97-bdff0682df8b	2020-06-12	Adverse reactions	Exact identifier application applno (NDA): 018333 application number: NDA018333 ndc (product): 59762-0401
Sucralfate	SUCRALFATE	Aphena Pharma Solutions - Tennessee, LLC	84447e21-e311-4e9f-9065-53956e90135c	2019-04-22	Adverse reactions	Exact identifier application applno (NDA): 018333 application number: NDA018333 ndc (product): 71610-017

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 19 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0591-0780	Sucralfate	Sucralfate	Actavis Pharma, Inc.	NDA AUTHORIZED GENERIC	Current
43353-061	Sucralfate	Sucralfate	Aphena Pharma Solutions - Tennessee, LLC	NDA	Current
50090-5287	Sucralfate	Sucralfate	A-S Medication Solutions	NDA AUTHORIZED GENERIC	Current
53808-0593	Sucralfate	SUCRALFATE	State of Florida DOH Central Pharmacy	NDA	Current
55289-292	Sucralfate	Sucralfate	PD-Rx Pharmaceuticals, In	NDA AUTHORIZED	Current
55289-292	Sucralfate	Sucralfate	PD-Rx Pharmaceuticals, Inc.	NDA AUTHORIZED GENERIC	Current
58914-171	Carafate	Sucralfate	Allergan, Inc.	NDA	Current
58914-171	Carafate	Sucralfate	Allergan, Inc.	NDA	Current
58914-171	Carafate	Sucralfate	Allergan, Inc.	NDA	Current
59762-0401	Sucralfate	Sucralfate	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-0401	Sucralfate	Sucralfate	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-0401	Sucralfate	Sucralfate	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
63629-6535	Sucralfate	Sucralfate	Bryant Ranch Prepack	NDA AUTHORIZED GENERIC	Current
68788-8316	Sucralfate	Sucralfate	Preferred Pharmaceuticals Inc.	NDA AUTHORIZED GENERIC	Current
70934-446	Sucralfate	Sucralfate	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	NDA AUTHORIZED GENERIC	Current
70934-525	Sucralfate	Sucralfate	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	NDA AUTHORIZED GENERIC	Current
71610-017	Sucralfate	Sucralfate	Aphena Pharma Solutions - Tennessee, LLC	NDA AUTHORIZED GENERIC	Current
71610-017	Sucralfate	Sucralfate	Aphena Pharma Solutions - Tennessee, LLC	NDA AUTHORIZED GENERIC	Current
80425-0213	Sucralfate	Sucralfate	Advanced Rx Pharmacy of Tennessee, LLC	NDA AUTHORIZED GENERIC	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
11207	SUPPL	2013-03-08
14982	SUPPL	2013-03-05
14981	SUPPL	2007-05-01
11206	SUPPL	2007-05-01