Application 206548

Type: ANDA
Sponsor: AUROBINDO PHARMA LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LOPERAMIDE HYDROCHLORIDE	LOPERAMIDE HYDROCHLORIDE	TABLET;ORAL	2MG	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
A206548-001	LOPERAMIDE HYDROCHLORIDE	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL			2015-12-15

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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A206548-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2015-12-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206548-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2015-12-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206548-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2015-12-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206548-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2015-12-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206548-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2015-12-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206548-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2015-12-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206548-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2015-12-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206548-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2015-12-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206548-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2015-12-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206548-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2015-12-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206548-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2015-12-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206548-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2015-12-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206548-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2015-12-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206548-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2015-12-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206548-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2015-12-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206548-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2015-12-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206548-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2015-12-15	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A206548-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2015-12-15	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A206548-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2015-12-15	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A206548-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2015-12-15	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A206548-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2015-12-15	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A206548-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2015-12-15	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A206548-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2015-12-15	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A206548-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2015-12-15	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A206548-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2015-12-15	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A206548-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2015-12-15	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A206548-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2015-12-15	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A206548-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2015-12-15	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A206548-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2015-12-15	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A206548-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2015-12-15	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A206548-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2015-12-15	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A206548-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2015-12-15	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A206548-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2015-12-15	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A206548-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2015-12-15	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A206548-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2015-12-15	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A206548-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2015-12-15	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A206548-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2015-12-15	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A206548-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2015-12-15	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A206548-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2015-12-15	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A206548-001	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET / ORAL	2015-12-15	`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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Loperamide Hydrochloride	LOPERAMIDE HYDROCHLORIDE	YYBA CORP	568064c9-139d-7233-e063-6294a90a10d4	2026-07-13	Warnings	Exact identifier application applno (ANDA): 206548 application number: ANDA206548
Loperamide Hydrochloride	LOPERAMIDE HYDROCHLORIDE	Aurobindo Pharma Limited	8e4004be-bf79-4631-9e38-c4e7b6726313	2026-06-03	Warnings	Exact identifier application applno (ANDA): 206548 application number: ANDA206548
AMAZON BASIC CARE LOPERAMIDE HYDROCHLORIDE	LOPERAMIDE HYDROCHLORIDE	Proficient Rx LP	5e1358fc-76de-486a-80dd-7f41e037d9a0	2026-06-01	Warnings	Exact identifier application applno (ANDA): 206548 application number: ANDA206548
Loperamide Hydrochloride	LOPERAMIDE HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	5b173bb9-3cca-44ce-9bcb-b9ecc93d3dcf	2026-05-28	Warnings	Exact identifier application applno (ANDA): 206548 application number: ANDA206548
Loperamide Hydrochloride	LOPERAMIDE HYDROCHLORIDE	Aurohealth LLC	f3ea8779-252e-4038-ae41-500e15c54825	2025-01-22	Warnings	Exact identifier application applno (ANDA): 206548 application number: ANDA206548 ndc (product): 58602-701
AMAZON BASIC CARE LOPERAMIDE HYDROCHLORIDE	LOPERAMIDE HYDROCHLORIDE	Amazon.com Services LLC	10edd7bc-fc35-abe3-e063-6394a90aeb3f	2024-05-15	Warnings	Exact identifier application applno (ANDA): 206548 application number: ANDA206548
Loperamide Hydrochloride	LOPERAMIDE HYDROCHLORIDE	Amerisource Bergen	6c15f077-9f90-4262-9c17-a1ac70e45f57	2024-03-29	Warnings	Exact identifier application applno (ANDA): 206548 application number: ANDA206548
Loperamide Hydrochloride	LOPERAMIDE HYDROCHLORIDE	Aurohealth LLC	93ebbb23-a9f0-4519-9793-c9056be39f23	2022-03-22	Warnings	Exact identifier application applno (ANDA): 206548 application number: ANDA206548 ndc (product): 58602-870

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 9 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
58602-701	Loperamide Hydrochloride	Loperamide Hydrochloride	Aurohealth LLC	ANDA	Current
58602-701	Loperamide Hydrochloride	Loperamide Hydrochloride	Aurohealth LLC	ANDA	Current
58602-701	Loperamide Hydrochloride	Loperamide Hydrochloride	Aurohealth LLC	ANDA	Current
58602-701	Loperamide Hydrochloride	Loperamide Hydrochloride	Aurohealth LLC	ANDA	Current
58602-701	Loperamide Hydrochloride	Loperamide Hydrochloride	Aurohealth LLC	ANDA	Current
58602-701	Loperamide Hydrochloride	Loperamide Hydrochloride	Aurohealth LLC	ANDA	Current
58602-701	Loperamide Hydrochloride	Loperamide Hydrochloride	Aurohealth LLC	ANDA	Current
58602-827	Loperamide Hydrochloride	Loperamide Hydrochloride	Aurohealth LLC	ANDA	Current
58602-870	Loperamide Hydrochloride	Loperamide Hydrochloride	Aurohealth LLC	ANDA	Current