Application 211438

Type: ANDA
Sponsor: HETERO LABS LTD V

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	LOPERAMIDE HYDROCHLORIDE; SIMETHICONE	TABLET;ORAL	2MG;125MG	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
A211438-001	LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	LOPERAMIDE HYDROCHLORIDE; SIMETHICONE	2MG;125MG	TABLET / ORAL			2021-06-17

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.

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	A211438-001	LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	2MG;125MG	TABLET / ORAL	2021-06-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211438-001	LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	2MG;125MG	TABLET / ORAL	2021-06-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211438-001	LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	2MG;125MG	TABLET / ORAL	2021-06-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211438-001	LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	2MG;125MG	TABLET / ORAL	2021-06-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211438-001	LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	2MG;125MG	TABLET / ORAL	2021-06-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211438-001	LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	2MG;125MG	TABLET / ORAL	2021-06-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211438-001	LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	2MG;125MG	TABLET / ORAL	2021-06-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211438-001	LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	2MG;125MG	TABLET / ORAL	2021-06-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211438-001	LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	2MG;125MG	TABLET / ORAL	2021-06-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211438-001	LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	2MG;125MG	TABLET / ORAL	2021-06-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211438-001	LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	2MG;125MG	TABLET / ORAL	2021-06-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211438-001	LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	2MG;125MG	TABLET / ORAL	2021-06-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211438-001	LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	2MG;125MG	TABLET / ORAL	2021-06-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211438-001	LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	2MG;125MG	TABLET / ORAL	2021-06-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211438-001	LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	2MG;125MG	TABLET / ORAL	2021-06-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211438-001	LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	2MG;125MG	TABLET / ORAL	2021-06-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211438-001	LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	2MG;125MG	TABLET / ORAL	2021-06-17	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A211438-001	LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	2MG;125MG	TABLET / ORAL	2021-06-17	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211438-001	LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	2MG;125MG	TABLET / ORAL	2021-06-17	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211438-001	LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	2MG;125MG	TABLET / ORAL	2021-06-17	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A211438-001	LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	2MG;125MG	TABLET / ORAL	2021-06-17	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A211438-001	LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	2MG;125MG	TABLET / ORAL	2021-06-17	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211438-001	LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	2MG;125MG	TABLET / ORAL	2021-06-17	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211438-001	LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	2MG;125MG	TABLET / ORAL	2021-06-17	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211438-001	LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	2MG;125MG	TABLET / ORAL	2021-06-17	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A211438-001	LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	2MG;125MG	TABLET / ORAL	2021-06-17	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A211438-001	LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	2MG;125MG	TABLET / ORAL	2021-06-17	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A211438-001	LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	2MG;125MG	TABLET / ORAL	2021-06-17	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211438-001	LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	2MG;125MG	TABLET / ORAL	2021-06-17	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A211438-001	LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	2MG;125MG	TABLET / ORAL	2021-06-17	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A211438-001	LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	2MG;125MG	TABLET / ORAL	2021-06-17	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A211438-001	LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	2MG;125MG	TABLET / ORAL	2021-06-17	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A211438-001	LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	2MG;125MG	TABLET / ORAL	2021-06-17	`a50c72e98297…`

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
Loperamide Hydrochloride and Simethicone	LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	IMO-GEN LABS LLC	41d6dba5-e411-c8d2-e063-6294a90ae8fa	2025-10-23	Warnings	Exact identifier application applno (ANDA): 211438 application number: ANDA211438
Loperamide Hydrochloride and Simethicone	LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	FSA store INC	0199a50f-f367-40e7-8af0-745a959d3fde	2025-04-05	Warnings	Exact identifier application applno (ANDA): 211438 application number: ANDA211438
Loperamide Hydrochloride and Simethicone	LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	Camber Consumer Care Inc	e2a4af66-1d05-408c-9f11-f2a9f325d75c	2022-09-12	Warnings	Exact identifier application applno (ANDA): 211438 application number: ANDA211438 ndc (product): 69230-325

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
69230-325	Loperamide Hydrochloride and Simethicone	Loperamide Hydrochloride and Simethicone	Camber Consumer Care Inc	ANDA	Current
69230-325	Loperamide Hydrochloride and Simethicone	Loperamide Hydrochloride and Simethicone	Camber Consumer Care Inc	ANDA	Current