Application 019183

Type: NDA
Sponsor: ALLERGAN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CARAFATE	SUCRALFATE	SUSPENSION;ORAL	1GM/10ML	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
N019183-001	CARAFATE	SUCRALFATE	1GM/10ML	SUSPENSION / ORAL		RLD	1993-12-16

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	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N019183-001	CARAFATE	1GM/10ML	SUSPENSION / ORAL		RLD	1993-12-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N019183-001	CARAFATE	1GM/10ML	SUSPENSION / ORAL	AB	RLD, RS	1993-12-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019183-001	CARAFATE	1GM/10ML	SUSPENSION / ORAL	AB	RLD, RS	1993-12-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019183-001	CARAFATE	1GM/10ML	SUSPENSION / ORAL	AB	RLD, RS	1993-12-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019183-001	CARAFATE	1GM/10ML	SUSPENSION / ORAL	AB	RLD, RS	1993-12-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019183-001	CARAFATE	1GM/10ML	SUSPENSION / ORAL	AB	RLD, RS	1993-12-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019183-001	CARAFATE	1GM/10ML	SUSPENSION / ORAL	AB	RLD, RS	1993-12-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019183-001	CARAFATE	1GM/10ML	SUSPENSION / ORAL	AB	RLD, RS	1993-12-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019183-001	CARAFATE	1GM/10ML	SUSPENSION / ORAL	AB	RLD, RS	1993-12-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019183-001	CARAFATE	1GM/10ML	SUSPENSION / ORAL	AB	RLD, RS	1993-12-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N019183-001	CARAFATE	1GM/10ML	SUSPENSION / ORAL	AB	RLD, RS	1993-12-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019183-001	CARAFATE	1GM/10ML	SUSPENSION / ORAL	AB	RLD, RS	1993-12-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019183-001	CARAFATE	1GM/10ML	SUSPENSION / ORAL	AB	RLD, RS	1993-12-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019183-001	CARAFATE	1GM/10ML	SUSPENSION / ORAL	AB	RLD, RS	1993-12-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N019183-001	CARAFATE	1GM/10ML	SUSPENSION / ORAL	AB	RLD, RS	1993-12-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019183-001	CARAFATE	1GM/10ML	SUSPENSION / ORAL	AB	RLD, RS	1993-12-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N019183-001	CARAFATE	1GM/10ML	SUSPENSION / ORAL	AB	RLD, RS	1993-12-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N019183-001	CARAFATE	1GM/10ML	SUSPENSION / ORAL	AB	RLD, RS	1993-12-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N019183-001	CARAFATE	1GM/10ML	SUSPENSION / ORAL		RLD, RS	1993-12-16	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N019183-001	CARAFATE	1GM/10ML	SUSPENSION / ORAL	AB	RLD, RS	1993-12-16	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N019183-001	CARAFATE	1GM/10ML	SUSPENSION / ORAL	AB	RLD, RS	1993-12-16	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N019183-001	CARAFATE	1GM/10ML	SUSPENSION / ORAL	AB	RLD, RS	1993-12-16	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N019183-001	CARAFATE	1GM/10ML	SUSPENSION / ORAL	AB	RLD, RS	1993-12-16	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N019183-001	CARAFATE	1GM/10ML	SUSPENSION / ORAL	AB	RLD, RS	1993-12-16	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N019183-001	CARAFATE	1GM/10ML	SUSPENSION / ORAL	AB	RLD, RS	1993-12-16	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N019183-001	CARAFATE	1GM/10ML	SUSPENSION / ORAL	AB	RLD, RS	1993-12-16	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N019183-001	CARAFATE	1GM/10ML	SUSPENSION / ORAL		RLD, RS	1993-12-16	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N019183-001	CARAFATE	1GM/10ML	SUSPENSION / ORAL		RLD, RS	1993-12-16	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N019183-001	CARAFATE	1GM/10ML	SUSPENSION / ORAL	AB	RLD, RS	1993-12-16	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N019183-001	CARAFATE	1GM/10ML	SUSPENSION / ORAL	AB	RLD, RS	1993-12-16	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N019183-001	CARAFATE	1GM/10ML	SUSPENSION / ORAL	AB	RLD, RS	1993-12-16	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N019183-001	CARAFATE	1GM/10ML	SUSPENSION / ORAL	AB	RLD, RS	1993-12-16	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N019183-001	CARAFATE	1GM/10ML	SUSPENSION / ORAL	AB	RLD, RS	1993-12-16	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N019183-001	CARAFATE	1GM/10ML	SUSPENSION / ORAL	AB	RLD, RS	1993-12-16	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N019183-001	CARAFATE	1GM/10ML	SUSPENSION / ORAL	AB	RLD, RS	1993-12-16	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N019183-001	CARAFATE	1GM/10ML	SUSPENSION / ORAL	AB	RLD, RS	1993-12-16	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N019183-001	CARAFATE	1GM/10ML	SUSPENSION / ORAL	AB	RLD, RS	1993-12-16	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N019183-001	CARAFATE	1GM/10ML	SUSPENSION / ORAL	AB	RLD, RS	1993-12-16	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N019183-001	CARAFATE	1GM/10ML	SUSPENSION / ORAL	AB	RLD, RS	1993-12-16	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N019183-001	CARAFATE	1GM/10ML	SUSPENSION / ORAL	AB	RLD, RS	1993-12-16	`e64feba35796…`

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	N019183-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019183-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019183-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019183-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019183-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019183-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019183-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019183-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019183-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N019183-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019183-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019183-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019183-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N019183-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019183-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N019183-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N019183-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N019183-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N019183-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N019183-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N019183-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N019183-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N019183-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N019183-001	AB	1	`3f01610625f2…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N019183-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N019183-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N019183-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N019183-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N019183-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N019183-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N019183-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N019183-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N019183-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N019183-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N019183-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N019183-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N019183-001	AB	1	`cb3db0bc1861…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sucralfate	SUCRALFATE	Pacific Pharma, Inc.	7407c58e-766f-4e93-a1bb-c77892ae0174	2024-02-10	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019183 application number: NDA019183
Carafate	SUCRALFATE	Allergan, Inc.	0fb67b1c-b4c0-46f2-8a81-df1510e006aa	2023-06-08	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019183 application number: NDA019183 ndc (product): 58914-170

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 40 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0121-0747	Sucralfate	Sucralfate	Pharmaceutical Associates, Inc.	NDA	Current
0121-0747	Sucralfate	Sucralfate	Pharmaceutical Associates, Inc.	NDA	Current
0121-0747	Sucralfate	Sucralfate	Pharmaceutical Associates, Inc.	NDA	Current
0254-1011	Sucralfate	Sucralfate	Par Pharmaceutical Inc.	NDA AUTHORIZED GENERIC	Current
0254-1011	Sucralfate	Sucralfate	Par Pharmaceutical Inc.	NDA AUTHORIZED GENERIC	Current
17856-0170	Carafate	Sucralfate	Atlantic Biologicals Corps	NDA	Current
17856-0170	Carafate	Sucralfate	Atlantic Biologicals Corps	NDA	Current
17856-0170	Carafate	Sucralfate	ATLANTIC BIOLOGICALS CORP.	NDA	Current
17856-1011	Sucralfate	Sucralfate	ATLANTIC BIOLOGICALS CORP.	NDA AUTHORIZED GENERIC	Current
17856-1011	Sucralfate	Sucralfate	ATLANTIC BIOLOGICALS CORP.	NDA AUTHORIZED GENERIC	Current
55154-4057	Sucralfate	Sucralfate	Cardinal Health	NDA	Current
55154-5778	Sucralfate	Sucralfate	Cardinal Health 107, LLC	NDA	Current
55154-5778	Sucralfate	Sucralfate	Cardinal Health	NDA	Current
55154-5778	Sucralfate	Sucralfate	Cardinal Health	NDA	Current
55154-5778	Sucralfate	Sucralfate	Cardinal Health	NDA	Current
55154-5778	Sucralfate	Sucralfate	Cardinal Health	NDA	Current
55154-5778	Sucralfate	Sucralfate	Cardinal Health	NDA	Current
55154-5778	Sucralfate	Sucralfate	Cardinal Health	NDA	Current
55154-5778	Sucralfate	Sucralfate	Cardinal Health	NDA	Current
58914-170	Carafate	Sucralfate	Allergan, Inc.	NDA	Current
58914-170	Carafate	Sucralfate	Allergan, Inc.	NDA	Current
58914-170	Carafate	Sucralfate	Allergan, Inc.	NDA	Current
66689-790	Sucralfate	Sucralfate	VistaPharm, Inc.	NDA	Current
66689-790	Sucralfate	Sucralfate	VistaPharm, Inc.	NDA	Current
66689-790	Sucralfate	Sucralfate	VistaPharm, Inc.	NDA	Current
66689-790	Sucralfate	Sucralfate	VistaPharm, Inc.	NDA	Current
66689-790	Sucralfate	Sucralfate	VistaPharm, Inc.	NDA	Current
66689-790	Sucralfate	Sucralfate	VistaPharm, Inc.	NDA	Current
68094-043	Sucralfate	Sucralfate	Precision Dose, Inc.	NDA AUTHORIZED GENERIC	Current
68094-043	Sucralfate	Sucralfate	Precision Dose, Inc.	NDA AUTHORIZED GENERIC	Current
68094-043	Sucralfate	Sucralfate	Precision Dose, Inc.	NDA AUTHORIZED GENERIC	Current
68094-171	Sucralfate	Sucralfate	Precision Dose Inc.	NDA	Current
68094-171	Sucralfate	Sucralfate	Precision Dose Inc.	NDA	Current
68094-171	Sucralfate	Sucralfate	Precision Dose Inc.	NDA	Current
69339-148	Sucralfate	Sucralfate	Dash Pharmaceuticals LLC	NDA AUTHORIZED GENERIC	Current
69339-148	Sucralfate	Sucralfate	Dash Pharmaceuticals LLC	NDA AUTHORIZED GENERIC	Current
69339-148	Sucralfate	Sucralfate	Dash Pharmaceuticals LLC	NDA	Current
81646-101	Sucralfate	Sucralfate	PINNACLE PHARMA LLC	NDA AUTHORIZED GENERIC	Current
81646-101	Sucralfate	Sucralfate	PINNACLE PHARMA LLC	NDA AUTHORIZED GENERIC	Current
81646-1011	Sucralfate	Sucralfate	PINNACLE PHARMA LLC	NDA AUTHORIZED GENERIC	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
74238	SUPPL	2023-05-15
74237	SUPPL	2023-05-15
49489	SUPPL	2017-08-21
49428	SUPPL	2017-08-16
11446	SUPPL	2013-03-08
1246	SUPPL	2013-03-05
40878	ORIG	2011-02-15
16210	SUPPL	2010-12-28
11445	SUPPL	2010-12-26
16209	SUPPL	2007-05-01
11444	SUPPL	2007-05-01
16208	SUPPL	2006-02-22