Application 085372

Type: ANDA
Sponsor: LANNETT

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE	TABLET;ORAL	0.025MG;2.5MG	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
A085372-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE	0.025MG;2.5MG	TABLET / ORAL	AA	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
A085372-001	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 · 41 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
2026-02-19 14:30 UTC	2026-02	A085372-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG;2.5MG	TABLET / ORAL	AA	Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A085372-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG;2.5MG	TABLET / ORAL	AA	Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A085372-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG;2.5MG	TABLET / ORAL	AA	Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A085372-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG;2.5MG	TABLET / ORAL	AA	Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A085372-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG;2.5MG	TABLET / ORAL	AA	Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A085372-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG;2.5MG	TABLET / ORAL	AA	Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A085372-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG;2.5MG	TABLET / ORAL	AA	Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A085372-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG;2.5MG	TABLET / ORAL	AA	Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A085372-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG;2.5MG	TABLET / ORAL	AA	Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A085372-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG;2.5MG	TABLET / ORAL	AA	Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A085372-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG;2.5MG	TABLET / ORAL	AA	Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A085372-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG;2.5MG	TABLET / ORAL	AA	Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A085372-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG;2.5MG	TABLET / ORAL	AA	Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A085372-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG;2.5MG	TABLET / ORAL	AA	Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A085372-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG;2.5MG	TABLET / ORAL	AA	Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A085372-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG;2.5MG	TABLET / ORAL	AA	Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A085372-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG;2.5MG	TABLET / ORAL	AA	Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A085372-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG;2.5MG	TABLET / ORAL	AA	Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A085372-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG;2.5MG	TABLET / ORAL	AA	Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A085372-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG;2.5MG	TABLET / ORAL	AA	Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A085372-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG;2.5MG	TABLET / ORAL	AA	Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A085372-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG;2.5MG	TABLET / ORAL	AA	Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A085372-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG;2.5MG	TABLET / ORAL	AA	Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A085372-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG;2.5MG	TABLET / ORAL	AA	Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A085372-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG;2.5MG	TABLET / ORAL	AA	Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A085372-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG;2.5MG	TABLET / ORAL	AA	Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A085372-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG;2.5MG	TABLET / ORAL	AA	Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A085372-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG;2.5MG	TABLET / ORAL	AA	Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A085372-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG;2.5MG	TABLET / ORAL	AA	Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A085372-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG;2.5MG	TABLET / ORAL	AA	Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A085372-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG;2.5MG	TABLET / ORAL	AA	Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A085372-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG;2.5MG	TABLET / ORAL	AA	Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A085372-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG;2.5MG	TABLET / ORAL	AA	Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A085372-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG;2.5MG	TABLET / ORAL	AA	Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A085372-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG;2.5MG	TABLET / ORAL	AA	Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A085372-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG;2.5MG	TABLET / ORAL	AA	Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A085372-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG;2.5MG	TABLET / ORAL	AA	Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A085372-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG;2.5MG	TABLET / ORAL	AA	Approved before 1982	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A085372-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG;2.5MG	TABLET / ORAL	AA	Approved before 1982	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A085372-001	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	0.025MG;2.5MG	TABLET / ORAL	AA	Approved before 1982	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A085372-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A085372-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A085372-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A085372-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A085372-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A085372-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A085372-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A085372-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A085372-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A085372-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A085372-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A085372-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A085372-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A085372-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A085372-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A085372-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A085372-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A085372-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A085372-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A085372-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A085372-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A085372-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A085372-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A085372-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A085372-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A085372-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A085372-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A085372-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A085372-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A085372-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A085372-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A085372-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A085372-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A085372-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A085372-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A085372-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A085372-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A085372-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A085372-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A085372-001	AA	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 2 · 27 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Diphenoxylate Hydrochloride and Atropine Sulfate	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	A-S Medication Solutions	f94a0189-40d2-42e0-8d2b-c9dc433faad1	2026-07-29	Warnings, Adverse reactions	Name fallback brand name: Diphenoxylate Hydrochloride and Atropine Sulfate
Diphenoxylate Hydrochloride and Atropine Sulfate	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	REMEDYREPACK INC.	3d0e2877-7a74-433f-8a31-e3e54aa9dc9f	2026-06-10	Warnings, Adverse reactions	Name fallback brand name: Diphenoxylate Hydrochloride and Atropine Sulfate
Diphenoxylate Hydrochloride and Atropine Sulfate	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	Redpharm Drug	5342df5c-12bb-565c-e063-6294a90a4ade	2026-06-02	Warnings, Adverse reactions	Name fallback brand name: Diphenoxylate Hydrochloride and Atropine Sulfate
Diphenoxylate Hydrochloride and Atropine Sulfate	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	Bryant Ranch Prepack	bd08ed90-dd26-4629-83c0-0f75af6ebb95	2026-05-21	Warnings, Adverse reactions	Name fallback brand name: Diphenoxylate Hydrochloride and Atropine Sulfate
Diphenoxylate Hydrochloride and Atropine Sulfate	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	Preferred Pharmaceuticals Inc.	46d5b27b-a710-4767-b308-4f673ddb354c	2026-04-06	Warnings, Adverse reactions	Name fallback brand name: Diphenoxylate Hydrochloride and Atropine Sulfate
Diphenoxylate Hydrochloride and Atropine Sulfate	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	Mylan Pharmaceuticals Inc.	83bcc2fb-6fb0-4f0e-8e66-592d327684ec	2026-02-23	Warnings, Adverse reactions	Name fallback brand name: Diphenoxylate Hydrochloride and Atropine Sulfate
Diphenoxylate Hydrochloride and Atropine Sulfate	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	ANI Pharmaceuticals, Inc.	73dc5f91-d562-44c5-a556-66c96ed1dd82	2025-12-22	Warnings, Adverse reactions	Name fallback brand name: Diphenoxylate Hydrochloride and Atropine Sulfate
Diphenoxylate Hydrochloride and Atropine Sulfate	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	Unichem Pharmaceuticals (USA), Inc.	5117f26c-488f-4ba6-b115-22baf12557f3	2025-12-11	Warnings, Adverse reactions	Name fallback brand name: Diphenoxylate Hydrochloride and Atropine Sulfate
Diphenoxylate hydrochloride and atropine sulfate	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	Chartwell RX, LLC	240b537e-ff9b-45e3-9398-584372bd707a	2025-12-10	Warnings, Adverse reactions	Name fallback brand name: Diphenoxylate hydrochloride and atropine sulfate
Diphenoxylate Hydrochloride and Atropine Sulfate	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	American Health Packaging	d0a1c80d-6aae-4886-8c25-e2d29ca0836b	2025-07-30	Warnings, Adverse reactions	Name fallback brand name: Diphenoxylate Hydrochloride and Atropine Sulfate
Diphenoxylate Hydrochloride and Atropine Sulfate	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	Hikma Pharmaceuticals USA Inc.	88ed4ccf-9e35-4142-a5eb-d2b5edd36956	2025-06-26	Warnings, Adverse reactions	Name fallback brand name: Diphenoxylate Hydrochloride and Atropine Sulfate
Diphenoxylate Hydrochloride and Atropine Sulfate	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	PD-Rx Pharmaceuticals, Inc.	700aad61-fa8c-4ded-87b8-da966093075a	2025-04-17	Warnings, Adverse reactions	Name fallback brand name: Diphenoxylate Hydrochloride and Atropine Sulfate
Diphenoxylate Hydrochloride and Atropine Sulfate	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	Redpharm Drug Inc.	f4c35a82-5927-5bc2-e053-2a95a90aea4d	2025-01-23	Warnings, Adverse reactions	Name fallback brand name: Diphenoxylate Hydrochloride and Atropine Sulfate
DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	Direct Rx	d9a36478-4788-4107-e053-2a95a90ad6da	2025-01-21	Adverse reactions	Name fallback brand name: DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE
Diphenoxylate Hydrochloride and Atropine Sulfate	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	A-S Medication Solutions	1be4dd7d-766c-4b3c-8b86-4f219ab44726	2024-11-13	Warnings, Adverse reactions	Name fallback brand name: Diphenoxylate Hydrochloride and Atropine Sulfate
Diphenoxylate Hydrochloride and Atropine Sulfate	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	Bryant Ranch Prepack	b3f58de9-1cc8-4bc5-842f-010cc48d3582	2024-08-23	Warnings, Adverse reactions	Name fallback brand name: Diphenoxylate Hydrochloride and Atropine Sulfate
Diphenoxylate Hydrochloride and Atropine Sulfate	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	NuCare Pharmaceuticals,Inc.	575c38b4-7ec0-6d25-e053-2a91aa0a80fc	2024-07-18	Warnings, Adverse reactions	Name fallback brand name: Diphenoxylate Hydrochloride and Atropine Sulfate
Diphenoxylate Hydrochloride and Atropine Sulfate	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	Aphena Pharma Solutions - Tennessee, LLC	14bf7191-580f-76dc-e063-6294a90aed2a	2024-04-08	Warnings, Adverse reactions	Name fallback brand name: Diphenoxylate Hydrochloride and Atropine Sulfate
Diphenoxylate Hydrochloride and Atropine Sulfate	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	SpecGx LLC	24915aa0-1600-44bb-99fc-46529a794124	2023-06-27	Warnings, Adverse reactions	Name fallback brand name: Diphenoxylate Hydrochloride and Atropine Sulfate
Diphenoxylate Hydrochloride and Atropine Sulfate	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	Aphena Pharma Solutions - Tennessee, LLC	c11574c7-8344-4987-85ef-f2404daa0885	2023-06-13	Warnings, Adverse reactions	Name fallback brand name: Diphenoxylate Hydrochloride and Atropine Sulfate

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0527-1170	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	Lannett Company, Inc.	ANDA	Current
0527-1170	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	Lannett Company, Inc.	ANDA	Current
0527-1170	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	Lannett Company, Inc.	ANDA	Current
60687-569	Diphenoxylate Hydrochloride and Atropine Sulfate	Diphenoxylate Hydrochloride and Atropine Sulfate	American Health Packaging	ANDA	Current
60687-569	Diphenoxylate Hydrochloride and Atropine Sulfate	Diphenoxylate Hydrochloride and Atropine Sulfate	American Health Packaging	ANDA	Current
67296-1675	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	RedPharm Drug, Inc.	ANDA	Current