Application 073080

Type: ANDA
Sponsor: ROXANE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LOPERAMIDE HYDROCHLORIDE	LOPERAMIDE HYDROCHLORIDE	CAPSULE;ORAL	2MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A073080-001	LOPERAMIDE HYDROCHLORIDE	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL			1991-11-27

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 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A073080-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	1991-11-27	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A073080-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	1991-11-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A073080-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	1991-11-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A073080-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	1991-11-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A073080-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	1991-11-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A073080-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	1991-11-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A073080-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	1991-11-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A073080-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	1991-11-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A073080-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	1991-11-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A073080-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	1991-11-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A073080-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	1991-11-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A073080-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	1991-11-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A073080-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	1991-11-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A073080-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	1991-11-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A073080-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	1991-11-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A073080-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	1991-11-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A073080-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	1991-11-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A073080-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	1991-11-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A073080-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	1991-11-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A073080-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	1991-11-27	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A073080-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	1991-11-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A073080-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	1991-11-27	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A073080-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	1991-11-27	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A073080-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	1991-11-27	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A073080-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	1991-11-27	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A073080-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	1991-11-27	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A073080-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	1991-11-27	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A073080-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	1991-11-27	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A073080-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	1991-11-27	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A073080-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	1991-11-27	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A073080-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	1991-11-27	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A073080-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	1991-11-27	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A073080-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	1991-11-27	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A073080-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	1991-11-27	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A073080-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	1991-11-27	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A073080-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	1991-11-27	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A073080-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	1991-11-27	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A073080-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	1991-11-27	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A073080-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	1991-11-27	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A073080-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	1991-11-27	`f41ea6bd6efb…`

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 4 of 7 · 132 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Anti-Diarrheal	LOPERAMIDE HYDROCHLORIDE	CHAIN DRUG MARKETING ASSOCIATION INC.	35a938af-decf-5b5d-e063-6294a90a9ab0	2025-05-21	Warnings	Name fallback generic name: LOPERAMIDE HYDROCHLORIDE
Anti-Diarrheal	LOPERAMIDE HYDROCHLORIDE	CHAIN DRUG MARKETING ASSOCIATION INC.	35aa2daf-3486-7ee2-e063-6394a90ad473	2025-05-21	Warnings	Name fallback generic name: LOPERAMIDE HYDROCHLORIDE
loperamide hydrochloride	LOPERAMIDE HCL	ATLANTIC BIOLOGICALS CORP.	7030f4ed-3cd1-428e-9cae-3b14933d41f5	2025-05-12	Warnings	Name fallback brand name: loperamide hydrochloride
Loperamide hydrochloride	LOPERAMIDE HCL	CVS Pharmacy	4c620875-1d8d-4170-be93-8649d9d99f4a	2025-04-11	Warnings	Name fallback brand name: Loperamide hydrochloride
anti-diarrheal	LOPERAMIDE HYDROCHLORIDE	Albertsons Companies	1d4ec76d-ff0d-a55d-e063-6294a90ae22c	2025-04-07	Warnings	Name fallback generic name: LOPERAMIDE HYDROCHLORIDE
LOPERAMIDE HYDROCHLORIDE	LOPERAMIDE HYDROCHLORIDE	Bryant Ranch Prepack	86d94804-ad01-4106-8f23-033f3a6bab9e	2025-02-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: LOPERAMIDE HYDROCHLORIDE generic name: LOPERAMIDE HYDROCHLORIDE
anti diarrheal	LOPERAMIDE HYDROCHLORIDE	Redpharm Drug Inc	f4c23673-056e-7608-e053-2995a90a9276	2025-01-23	Warnings	Name fallback generic name: LOPERAMIDE HYDROCHLORIDE
Loperamide Hydrochloride	LOPERAMIDE HYDROCHLORIDE	Aurohealth LLC	f3ea8779-252e-4038-ae41-500e15c54825	2025-01-22	Warnings	Name fallback brand name: Loperamide Hydrochloride generic name: LOPERAMIDE HYDROCHLORIDE
Loperamide Hydrochloride	LOPERAMIDE HYDROCHLORIDE	AvPAK	f8992723-dd9a-bcf6-e053-6294a90aa65c	2025-01-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Loperamide Hydrochloride generic name: LOPERAMIDE HYDROCHLORIDE
Loperamide Hydrochloride	LOPERAMIDE HYDROCHLORIDE	Medline Industries, LP	03d68bcf-6413-4fe3-8263-39cc315452d2	2024-12-29	Warnings	Name fallback brand name: Loperamide Hydrochloride generic name: LOPERAMIDE HYDROCHLORIDE
Anti-Diarrheal	LOPERAMIDE HYDROCHLORIDE	DISCOUNT DRUG MART, INC.	ed28814d-9733-46ff-930f-b148e31f2f51	2024-12-23	Warnings	Name fallback generic name: LOPERAMIDE HYDROCHLORIDE
Anti-Diarrheal	LOPERAMIDE HYDROCHLORIDE	KROGER COMPANY	ff5dcb48-318c-4f2a-8df2-73ff6dd2a49e	2024-12-23	Warnings	Name fallback generic name: LOPERAMIDE HYDROCHLORIDE
Lil Drug Store Anti-Diarrheal	LOPERAMIDE HYDROCHLORIDE	Lil' Drug Store Products, Inc.	fc23b13e-3005-4f23-aec2-b02a0e48ea11	2024-11-27	Warnings	Name fallback generic name: LOPERAMIDE HYDROCHLORIDE
dg health anti diarrheal	LOPERAMIDE HYDROCHLORIDE	Dolgencorp, LLC	cac9e7e9-fb3a-497e-866d-347530ba4dfd	2024-11-11	Warnings	Name fallback generic name: LOPERAMIDE HYDROCHLORIDE
LOPERAMIDE HYDROCHLORIDE	LOPERAMIDE HYDROCHLORIDE	A-S Medication Solutions	d572ecf7-ddc3-46fb-80a6-80b7b1b90a1b	2024-10-25	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: LOPERAMIDE HYDROCHLORIDE generic name: LOPERAMIDE HYDROCHLORIDE
anti-diarrheal	LOPERAMIDE HYDROCHLORIDE	Safeway	9d0c565f-64a2-4300-b1e2-5dee9546ea14	2024-10-22	Warnings	Name fallback generic name: LOPERAMIDE HYDROCHLORIDE
LOPERAMIDE HYDROCHLORIDE	LOPERAMIDE HYDROCHLORIDE	NorthStar Rx LLC	858c2b62-98e6-46d7-9253-9b3a00040a4e	2024-10-21	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: LOPERAMIDE HYDROCHLORIDE generic name: LOPERAMIDE HYDROCHLORIDE
anti-diarrheal	LOPERAMIDE HYDROCHLORIDE	PUBLIX SUPER MARKETS INC	17035ff7-8ba8-131c-e063-6394a90af5ea	2024-10-03	Warnings	Name fallback generic name: LOPERAMIDE HYDROCHLORIDE
Loperamide Hydrochloride	LOPERAMIDE HYDROCHLORIDE	Bryant Ranch Prepack	865cf4c7-f643-451b-b0d4-d30bda621f7d	2024-08-20	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Loperamide Hydrochloride generic name: LOPERAMIDE HYDROCHLORIDE
LOPERAMIDE HYDROCHLORIDE	LOPERAMIDE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	1adb7a28-9dc6-3f8b-e063-6394a90a9335	2024-08-19	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: LOPERAMIDE HYDROCHLORIDE generic name: LOPERAMIDE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.