Application 070848

Type: ANDA
Sponsor: TEVA

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 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
A070848-001	SUCRALFATE	SUCRALFATE	1GM	TABLET / ORAL	AB		1996-03-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A070848-001	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	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A070848-001	SUCRALFATE	1GM	TABLET / ORAL	AB	1996-03-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A070848-001	SUCRALFATE	1GM	TABLET / ORAL	AB	1996-03-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070848-001	SUCRALFATE	1GM	TABLET / ORAL	AB	1996-03-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A070848-001	SUCRALFATE	1GM	TABLET / ORAL	AB	1996-03-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070848-001	SUCRALFATE	1GM	TABLET / ORAL	AB	1996-03-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070848-001	SUCRALFATE	1GM	TABLET / ORAL	AB	1996-03-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070848-001	SUCRALFATE	1GM	TABLET / ORAL	AB	1996-03-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A070848-001	SUCRALFATE	1GM	TABLET / ORAL	AB	1996-03-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A070848-001	SUCRALFATE	1GM	TABLET / ORAL	AB	1996-03-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A070848-001	SUCRALFATE	1GM	TABLET / ORAL	AB	1996-03-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A070848-001	SUCRALFATE	1GM	TABLET / ORAL	AB	1996-03-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A070848-001	SUCRALFATE	1GM	TABLET / ORAL	AB	1996-03-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A070848-001	SUCRALFATE	1GM	TABLET / ORAL	AB	1996-03-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A070848-001	SUCRALFATE	1GM	TABLET / ORAL	AB	1996-03-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A070848-001	SUCRALFATE	1GM	TABLET / ORAL	AB	1996-03-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A070848-001	SUCRALFATE	1GM	TABLET / ORAL	AB	1996-03-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A070848-001	SUCRALFATE	1GM	TABLET / ORAL	AB	1996-03-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A070848-001	SUCRALFATE	1GM	TABLET / ORAL	AB	1996-03-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A070848-001	SUCRALFATE	1GM	TABLET / ORAL	AB	1996-03-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A070848-001	SUCRALFATE	1GM	TABLET / ORAL	AB	1996-03-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A070848-001	SUCRALFATE	1GM	TABLET / ORAL	AB	1996-03-29	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A070848-001	SUCRALFATE	1GM	TABLET / ORAL	AB	1996-03-29	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A070848-001	SUCRALFATE	1GM	TABLET / ORAL	AB	1996-03-29	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A070848-001	SUCRALFATE	1GM	TABLET / ORAL	AB	1996-03-29	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A070848-001	SUCRALFATE	1GM	TABLET / ORAL	AB	1996-03-29	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A070848-001	SUCRALFATE	1GM	TABLET / ORAL	AB	1996-03-29	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A070848-001	SUCRALFATE	1GM	TABLET / ORAL	AB	1996-03-29	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A070848-001	SUCRALFATE	1GM	TABLET / ORAL	AB	1996-03-29	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A070848-001	SUCRALFATE	1GM	TABLET / ORAL	AB	1996-03-29	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A070848-001	SUCRALFATE	1GM	TABLET / ORAL	AB	1996-03-29	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A070848-001	SUCRALFATE	1GM	TABLET / ORAL	AB	1996-03-29	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A070848-001	SUCRALFATE	1GM	TABLET / ORAL	AB	1996-03-29	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A070848-001	SUCRALFATE	1GM	TABLET / ORAL	AB	1996-03-29	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A070848-001	SUCRALFATE	1GM	TABLET / ORAL	AB	1996-03-29	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A070848-001	SUCRALFATE	1GM	TABLET / ORAL	AB	1996-03-29	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A070848-001	SUCRALFATE	1GM	TABLET / ORAL	AB	1996-03-29	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A070848-001	SUCRALFATE	1GM	TABLET / ORAL	AB	1996-03-29	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A070848-001	SUCRALFATE	1GM	TABLET / ORAL	AB	1996-03-29	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A070848-001	SUCRALFATE	1GM	TABLET / ORAL	AB	1996-03-29	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A070848-001	SUCRALFATE	1GM	TABLET / ORAL	AB	1996-03-29	`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	A070848-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A070848-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070848-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A070848-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070848-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070848-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070848-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A070848-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A070848-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A070848-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A070848-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A070848-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A070848-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A070848-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A070848-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A070848-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A070848-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A070848-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A070848-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A070848-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A070848-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A070848-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A070848-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A070848-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A070848-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A070848-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A070848-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A070848-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A070848-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A070848-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A070848-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A070848-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A070848-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A070848-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A070848-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A070848-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A070848-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A070848-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A070848-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A070848-001	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 · 14 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sucralfate	SUCRALFATE	Cardinal Health 107, LLC	444a743a-4843-4b33-bad5-3dfc1fb2d004	2026-07-29	Adverse reactions	Exact identifier application applno (ANDA): 070848 application number: ANDA070848 ndc (product): 55154-4379
Sucralfate	SUCRALFATE	Cardinal Health 107, LLC	1eb38f64-4d5a-46e6-a030-057beece5e44	2026-07-10	Adverse reactions	Exact identifier application applno (ANDA): 070848 application number: ANDA070848
Sucralfate	SUCRALFATE	ASCLEMED USA INC.	cd25eb96-29ea-48b2-bdee-c2ea98f216b8	2026-05-18	Adverse reactions	Exact identifier application applno (ANDA): 070848 application number: ANDA070848
Sucralfate	SUCRALFATE	Safecor Health LLC	1a6d96f2-fe1f-4aaf-8520-616973c224aa	2026-04-07	Adverse reactions	Exact identifier application applno (ANDA): 070848 application number: ANDA070848
Sucralfate	SUCRALFATE	Northwind Health Company, LLC	464bf611-4dbb-4707-b9dd-39ca178ed4bf	2025-12-26	Adverse reactions	Exact identifier application applno (ANDA): 070848 application number: ANDA070848 ndc (product): 51655-031
Sucralfate	SUCRALFATE	Preferred Pharmaceuticals Inc.	5ec71444-cc55-47bd-8abc-b3cfc3b47d8e	2025-09-24	Adverse reactions	Exact identifier application applno (ANDA): 070848 application number: ANDA070848 ndc (product): 68788-8946
Sucralfate	SUCRALFATE	Mylan Institutional Inc.	989ca8a8-3ad6-4ee4-aa9c-eed731828753	2025-07-22	Adverse reactions	Exact identifier application applno (ANDA): 070848 application number: ANDA070848 ndc (product): 51079-753
Sucralfate	SUCRALFATE	NCS HealthCare of KY, LLC dba Vangard Labs	d67dcaad-56c1-4e77-a0c8-655970808414	2025-06-13	Adverse reactions	Exact identifier application applno (ANDA): 070848 application number: ANDA070848 ndc (product): 0615-4517
SUCRALFATE	SUCRALFATE	DIRECT RX	c50b5044-31ed-672a-e053-2995a90a49fc	2025-01-20	Adverse reactions	Exact identifier application applno (ANDA): 070848 application number: ANDA070848 ndc (product): 72189-234
Sucralfate	SUCRALFATE	Advanced Rx of Tennessee, LLC	b39f22c8-f224-451a-e053-2995a90aaad7	2024-12-31	Adverse reactions	Exact identifier application applno (ANDA): 070848 application number: ANDA070848 ndc (product): 80425-0091
Sucralfate	SUCRALFATE	NuCare Pharmaceuticals,Inc.	a40e43d4-9240-34ad-e053-2995a90a98e1	2024-07-15	Adverse reactions	Exact identifier application applno (ANDA): 070848 application number: ANDA070848 ndc (product): 68071-1749
Sucralfate	SUCRALFATE	Proficient Rx LP	a42c5f3d-85f1-485b-91e6-58c25b3ddc71	2024-01-01	Adverse reactions	Exact identifier application applno (ANDA): 070848 application number: ANDA070848
Sucralfate	SUCRALFATE	Bryant Ranch Prepack	2687d670-8af6-42a2-9081-fee112e80fc0	2023-05-24	Adverse reactions	Exact identifier application applno (ANDA): 070848 application number: ANDA070848 ndc (product): 63629-1307
Sucralfate	SUCRALFATE	Teva Pharmaceuticals USA, Inc.	c7a43df7-eb37-4273-9250-87953b1fd270	2015-09-01	Adverse reactions	Exact identifier application applno (ANDA): 070848 application number: ANDA070848 ndc (product): 0093-2210

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 57 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0093-2210	Sucralfate	Sucralfate	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-2210	Sucralfate	Sucralfate	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-2210	Sucralfate	Sucralfate	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-2210	Sucralfate	Sucralfate	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0591-3892	Sucralfate	Sucralfate	Actavis Pharma, Inc.	ANDA	Current
0615-4517	Sucralfate	Sucralfate	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
42291-757	Sucralfate	Sucralfate	AvKARE, Inc.	ANDA	Current
42291-757	Sucralfate	Sucralfate	AvKARE	ANDA	Current
45865-845	Sucralfate	Sucralfate	Medsource Pharmaceuticals	ANDA	Current
50090-0582	Sucralfate	Sucralfate	A-S Medication Solutions	ANDA	Current
50090-0582	Sucralfate	Sucralfate	A-S Medication Solutions	ANDA	Current
50090-3019	Sucralfate	Sucralfate	A-S Medication Solutions	ANDA	Current
51079-753	Sucralfate	Sucralfate	Mylan Institutional Inc.	ANDA	Current
51079-753	Sucralfate	Sucralfate	Mylan Institutional Inc.	ANDA	Current
51079-753	Sucralfate	Sucralfate	Mylan Institutional Inc.	ANDA	Current
51655-031	SUCRALFATE	SUCRALFATE	Northwind Pharmaceuticals, LLC	ANDA	Current
53002-4930	Sucralfate	Sucralfate	RPK Pharmaceuticals, Inc.	ANDA	Current
53002-4930	Sucralfate	Sucralfate	RPK Pharmaceuticals, Inc.	ANDA	Current
53808-0797	Sucralfate	SUCRALFATE	State of Florida DOH Central Pharmacy	ANDA	Current
55154-4379	Sucralfate	Sucralfate	Cardinal Health 107, LLC	ANDA	Current
55154-4379	Sucralfate	Sucralfate	Cardinal Health	ANDA	Current
55154-4379	Sucralfate	Sucralfate	Cardinal Health	ANDA	Current
55154-4379	Sucralfate	Sucralfate	Cardinal Health	ANDA	Current
55154-8133	Sucralfate	Sucralfate	Cardinal Health	ANDA	Current
55154-8133	Sucralfate	Sucralfate	Cardinal Health	ANDA	Current
55154-8133	Sucralfate	Sucralfate	Cardinal Health	ANDA	Current
63629-1307	Sucralfate	Sucralfate	Bryant Ranch Prepack	ANDA	Current
63629-1307	Sucralfate	Sucralfate	Bryant Ranch Prepack	ANDA	Current
63629-1307	Sucralfate	Sucralfate	Bryant Ranch Prepack	ANDA	Current
63629-1307	Sucralfate	Sucralfate	Bryant Ranch Prepack	ANDA	Current
63629-7957	Sucralfate	Sucralfate	Bryant Ranch Prepack	ANDA	Current
63739-943	Sucralfate	Sucralfate	McKesson Corporation dba SKY Packaging	ANDA	Current
63739-943	Sucralfate	Sucralfate	McKesson Corporation	ANDA	Current
63739-943	Sucralfate	Sucralfate	McKesson Corporation dba SKY Packaging	ANDA	Current
63739-943	Sucralfate	Sucralfate	McKesson Corporation dba SKY Packaging	ANDA	Current
63739-943	Sucralfate	Sucralfate	McKesson Corporation dba SKY Packaging	ANDA	Current
66267-596	Sucralfate	Sucralfate	NuCare Pharmaceuticals, Inc.	ANDA	Current
66267-596	Sucralfate	Sucralfate	NuCare Pharmaceuticals, Inc.	ANDA	Current
66267-596	Sucralfate	Sucralfate	NuCare Pharmaceuticals, Inc.	ANDA	Current
68071-1749	Sucralfate	Sucralfate	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-1749	Sucralfate	Sucralfate	NuCare Pharmaceuticals,Inc.	ANDA	Current
68788-8946	Sucralfate	Sucralfate	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-8946	Sucralfate	Sucralfate	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-8946	Sucralfate	Sucralfate	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-8946	Sucralfate	Sucralfate	Preferred Pharmaceuticals Inc.	ANDA	Current
70518-0775	Sucralfate	Sucralfate	REMEDYREPACK INC.	ANDA	Current
70518-0775	Sucralfate	Sucralfate	REMEDYREPACK INC.	ANDA	Current
70518-0775	Sucralfate	Sucralfate	REMEDYREPACK INC.	ANDA	Current
70518-0775	Sucralfate	Sucralfate	REMEDYREPACK INC.	ANDA	Current
70518-0775	Sucralfate	Sucralfate	REMEDYREPACK INC.	ANDA	Current
71610-244	Sucralfate	Sucralfate	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
72189-234	SUCRALFATE	SUCRALFATE	DIRECT RX	ANDA	Current
72189-234	SUCRALFATE	SUCRALFATE	DIRECT RX	ANDA	Current
76519-1025	SUCRALFATE	SUCRALFATE	H.J. Harkins Company, Inc.	ANDA	Current
80425-0091	Carafate	Sucralfate 1gm	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current
80425-0091	Sucralfate	Sucralfate	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current
80425-0091	Sucralfate	Sucralfate	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
22321	ORIG	2005-07-15