Application 012462

Type: NDA
Sponsor: GD SEARLE LLC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LOMOTIL	ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE	TABLET;ORAL	0.025MG;2.5MG	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
N012462-001	LOMOTIL	ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE	0.025MG;2.5MG	TABLET / ORAL	AA	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
N012462-001	AA

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	N012462-001	LOMOTIL	0.025MG;2.5MG	TABLET / ORAL	AA	RLD, RS, Approved before 1982	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N012462-001	LOMOTIL	0.025MG;2.5MG	TABLET / ORAL	AA	RLD, RS, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N012462-001	LOMOTIL	0.025MG;2.5MG	TABLET / ORAL	AA	RLD, RS, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N012462-001	LOMOTIL	0.025MG;2.5MG	TABLET / ORAL	AA	RLD, RS, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N012462-001	LOMOTIL	0.025MG;2.5MG	TABLET / ORAL	AA	RLD, RS, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N012462-001	LOMOTIL	0.025MG;2.5MG	TABLET / ORAL	AA	RLD, RS, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N012462-001	LOMOTIL	0.025MG;2.5MG	TABLET / ORAL	AA	RLD, RS, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N012462-001	LOMOTIL	0.025MG;2.5MG	TABLET / ORAL	AA	RLD, RS, Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N012462-001	LOMOTIL	0.025MG;2.5MG	TABLET / ORAL	AA	RLD, RS, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N012462-001	LOMOTIL	0.025MG;2.5MG	TABLET / ORAL	AA	RLD, RS, Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N012462-001	LOMOTIL	0.025MG;2.5MG	TABLET / ORAL	AA	RLD, RS, Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N012462-001	LOMOTIL	0.025MG;2.5MG	TABLET / ORAL	AA	RLD, RS, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N012462-001	LOMOTIL	0.025MG;2.5MG	TABLET / ORAL	AA	RLD, RS, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N012462-001	LOMOTIL	0.025MG;2.5MG	TABLET / ORAL	AA	RLD, RS, Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N012462-001	LOMOTIL	0.025MG;2.5MG	TABLET / ORAL	AA	RLD, RS, Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N012462-001	LOMOTIL	0.025MG;2.5MG	TABLET / ORAL	AA	RLD, RS, Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N012462-001	LOMOTIL	0.025MG;2.5MG	TABLET / ORAL	AA	RLD, RS, Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N012462-001	LOMOTIL	0.025MG;2.5MG	TABLET / ORAL	AA	RLD, RS, Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N012462-001	LOMOTIL	0.025MG;2.5MG	TABLET / ORAL	AA	RLD, RS, Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N012462-001	LOMOTIL	0.025MG;2.5MG	TABLET / ORAL	AA	RLD, RS, Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N012462-001	LOMOTIL	0.025MG;2.5MG	TABLET / ORAL	AA	RLD, RS, Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N012462-001	LOMOTIL	0.025MG;2.5MG	TABLET / ORAL	AA	RLD, RS, Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N012462-001	LOMOTIL	0.025MG;2.5MG	TABLET / ORAL	AA	RLD, RS, Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N012462-001	LOMOTIL	0.025MG;2.5MG	TABLET / ORAL	AA	RLD, RS, Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N012462-001	LOMOTIL	0.025MG;2.5MG	TABLET / ORAL	AA	RLD, RS, Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N012462-001	LOMOTIL	0.025MG;2.5MG	TABLET / ORAL	AA	RLD, RS, Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N012462-001	LOMOTIL	0.025MG;2.5MG	TABLET / ORAL	AA	RLD, RS, Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N012462-001	LOMOTIL	0.025MG;2.5MG	TABLET / ORAL	AA	RLD, RS, Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N012462-001	LOMOTIL	0.025MG;2.5MG	TABLET / ORAL	AA	RLD, RS, Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N012462-001	LOMOTIL	0.025MG;2.5MG	TABLET / ORAL	AA	RLD, RS, Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N012462-001	LOMOTIL	0.025MG;2.5MG	TABLET / ORAL	AA	RLD, RS, Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N012462-001	LOMOTIL	0.025MG;2.5MG	TABLET / ORAL	AA	RLD, RS, Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N012462-001	LOMOTIL	0.025MG;2.5MG	TABLET / ORAL	AA	RLD, RS, Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N012462-001	LOMOTIL	0.025MG;2.5MG	TABLET / ORAL	AA	RLD, RS, Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N012462-001	LOMOTIL	0.025MG;2.5MG	TABLET / ORAL	AA	RLD, RS, Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N012462-001	LOMOTIL	0.025MG;2.5MG	TABLET / ORAL	AA	RLD, RS, Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N012462-001	LOMOTIL	0.025MG;2.5MG	TABLET / ORAL	AA	RLD, RS, Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N012462-001	LOMOTIL	0.025MG;2.5MG	TABLET / ORAL	AA	RLD, RS, Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N012462-001	LOMOTIL	0.025MG;2.5MG	TABLET / ORAL	AA	RLD, RS, Approved before 1982	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N012462-001	LOMOTIL	0.025MG;2.5MG	TABLET / ORAL	AA	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	N012462-001	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N012462-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N012462-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N012462-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N012462-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N012462-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N012462-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N012462-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N012462-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N012462-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N012462-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N012462-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N012462-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N012462-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N012462-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N012462-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N012462-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N012462-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N012462-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N012462-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N012462-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N012462-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N012462-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N012462-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N012462-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N012462-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N012462-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N012462-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N012462-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N012462-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N012462-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N012462-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N012462-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N012462-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N012462-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N012462-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N012462-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N012462-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N012462-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N012462-001	AA	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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lomotil	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	Pfizer Laboratories Div Pfizer Inc	f170584a-1072-4fd7-b1dc-6756703483b9	2026-02-23	Warnings, Adverse reactions	Exact identifier application applno (NDA): 012462 application number: NDA012462 ndc (product): 0025-0061
Diphenoxylate Hydrochloride and Atropine Sulfate	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	Mylan Pharmaceuticals Inc.	83bcc2fb-6fb0-4f0e-8e66-592d327684ec	2026-02-23	Warnings, Adverse reactions	Exact identifier application applno (NDA): 012462 application number: NDA012462 ndc (product): 59762-1061
Diphenoxylate Hydrochloride and Atropine Sulfate	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	Aphena Pharma Solutions - Tennessee, LLC	59934cee-4e1f-4958-9e97-6de53b39daf3	2016-06-10	Warnings, Adverse reactions	Exact identifier application applno (NDA): 012462 application number: NDA012462 ndc (product): 43353-083

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 25 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0025-0061	Lomotil	diphenoxylate hydrochloride and atropine sulfate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0025-0061	Lomotil	diphenoxylate hydrochloride and atropine sulfate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0025-0061	Lomotil	diphenoxylate hydrochloride and atropine sulfate	G.D. Searle LLC Division of Pfizer Inc	NDA	Current
0025-0061	Lomotil	diphenoxylate hydrochloride and atropine sulfate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0025-0061	Lomotil	diphenoxylate hydrochloride and atropine sulfate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
17856-1061	Diphenoxylate Hydrochloride and Atropine Sulfate	Diphenoxylate Hydrochloride and Atropine Sulfate	Atlantic Biologicals Corps	NDA AUTHORIZED GENERIC	Current
43353-083	Diphenoxylate Hydrochloride and Atropine Sulfate	DIPHENOXYLATE HYDROCHLORIDE and ATROPINE SULFATE	Aphena Pharma Solutions - Tennessee, LLC	NDA AUTHORIZED GENERIC	Current
50090-2641	Diphenoxylate Hydrochloride and Atropine Sulfate	Diphenoxylate Hydrochloride and Atropine Sulfate	A-S Medication Solutions	NDA AUTHORIZED GENERIC	Current
50090-2641	Diphenoxylate Hydrochloride and Atropine Sulfate	Diphenoxylate Hydrochloride and Atropine Sulfate	A-S Medication Solutions	NDA AUTHORIZED GENERIC	Current
50090-2872	Diphenoxylate Hydrochloride and Atropine Sulfate	Diphenoxylate Hydrochloride and Atropine Sulfate	A-S Medication Solutions	NDA AUTHORIZED GENERIC	Current
50090-2872	Diphenoxylate Hydrochloride and Atropine Sulfate	Diphenoxylate Hydrochloride and Atropine Sulfate	A-S Medication Solutions	NDA AUTHORIZED GENERIC	Current
55700-255	Diphenoxylate Hydrochloride and Atropine Sulfate	Diphenoxylate Hydrochloride and Atropine Sulfate	Lake Erie Medical DBA Quality Care Products LLC	NDA AUTHORIZED GENERIC	Current
59762-1061	Diphenoxylate Hydrochloride and Atropine Sulfate	Diphenoxylate Hydrochloride and Atropine Sulfate	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-1061	Diphenoxylate Hydrochloride and Atropine Sulfate	Diphenoxylate Hydrochloride and Atropine Sulfate	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
61919-080	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	Direct Rx	NDA AUTHORIZED GENERIC	Current
67296-1210	Lomotil	Lomotil	RedPharm Drug, Inc.	NDA	Current
67296-1210	Lomotil	Lomotil	RedPharm Drug, Inc.	NDA	Current
67296-1210	Lomotil	Lomotil	RedPharm Drug, Inc.	NDA	Current
67296-1241	Diphenoxylate Hydrochloride and Atropine Sulfate	Diphenoxylate Hydrochloride and Atropine Sulfate	RedPharm Drug, Inc.	NDA AUTHORIZED GENERIC	Current
67296-1241	Diphenoxylate Hydrochloride and Atropine Sulfate	Diphenoxylate Hydrochloride and Atropine Sulfate	RedPharm Drug, Inc.	NDA AUTHORIZED GENERIC	Current
67296-1241	Diphenoxylate Hydrochloride and Atropine Sulfate	Diphenoxylate Hydrochloride and Atropine Sulfate	RedPharm Drug, Inc.	NDA AUTHORIZED GENERIC	Current
70518-2135	Diphenoxylate Hydrochloride and Atropine Sulfate	Diphenoxylate Hydrochloride and Atropine Sulfate	REMEDYREPACK INC.	NDA AUTHORIZED GENERIC	Current
70518-2135	Diphenoxylate Hydrochloride and Atropine Sulfate	Diphenoxylate Hydrochloride and Atropine Sulfate	REMEDYREPACK INC.	NDA AUTHORIZED GENERIC	Current
70518-2135	Diphenoxylate Hydrochloride and Atropine Sulfate	Diphenoxylate Hydrochloride and Atropine Sulfate	REMEDYREPACK INC.	NDA AUTHORIZED GENERIC	Current
70518-2135	Diphenoxylate Hydrochloride and Atropine Sulfate	Diphenoxylate Hydrochloride and Atropine Sulfate	REMEDYREPACK INC.	NDA AUTHORIZED GENERIC	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
52638	SUPPL	2018-02-14
52627	SUPPL	2018-02-14
49979	SUPPL	2017-10-06
49965	SUPPL	2017-10-06
335	SUPPL	2006-05-02