Application 077500

Type: ANDA
Sponsor: SUN PHARM INDS LTD

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
A077500-001	LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	LOPERAMIDE HYDROCHLORIDE; SIMETHICONE	2MG;125MG	TABLET / ORAL			2006-09-06

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	A077500-001	LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	2MG;125MG	TABLET / ORAL	2006-09-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077500-001	LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	2MG;125MG	TABLET / ORAL	2006-09-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077500-001	LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	2MG;125MG	TABLET / ORAL	2006-09-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077500-001	LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	2MG;125MG	TABLET / ORAL	2006-09-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077500-001	LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	2MG;125MG	TABLET / ORAL	2006-09-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077500-001	LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	2MG;125MG	TABLET / ORAL	2006-09-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077500-001	LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	2MG;125MG	TABLET / ORAL	2006-09-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077500-001	LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	2MG;125MG	TABLET / ORAL	2006-09-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077500-001	LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	2MG;125MG	TABLET / ORAL	2006-09-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077500-001	LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	2MG;125MG	TABLET / ORAL	2006-09-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077500-001	LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	2MG;125MG	TABLET / ORAL	2006-09-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077500-001	LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	2MG;125MG	TABLET / ORAL	2006-09-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077500-001	LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	2MG;125MG	TABLET / ORAL	2006-09-06	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077500-001	LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	2MG;125MG	TABLET / ORAL	2006-09-06	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077500-001	LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	2MG;125MG	TABLET / ORAL	2006-09-06	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077500-001	LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	2MG;125MG	TABLET / ORAL	2006-09-06	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077500-001	LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	2MG;125MG	TABLET / ORAL	2006-09-06	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077500-001	LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	2MG;125MG	TABLET / ORAL	2006-09-06	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077500-001	LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	2MG;125MG	TABLET / ORAL	2006-09-06	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077500-001	LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	2MG;125MG	TABLET / ORAL	2006-09-06	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077500-001	LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	2MG;125MG	TABLET / ORAL	2006-09-06	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077500-001	LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	2MG;125MG	TABLET / ORAL	2006-09-06	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077500-001	LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	2MG;125MG	TABLET / ORAL	2006-09-06	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077500-001	LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	2MG;125MG	TABLET / ORAL	2006-09-06	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077500-001	LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	2MG;125MG	TABLET / ORAL	2006-09-06	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077500-001	LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	2MG;125MG	TABLET / ORAL	2006-09-06	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077500-001	LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	2MG;125MG	TABLET / ORAL	2006-09-06	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077500-001	LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	2MG;125MG	TABLET / ORAL	2006-09-06	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A077500-001	LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	2MG;125MG	TABLET / ORAL	2006-09-06	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A077500-001	LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	2MG;125MG	TABLET / ORAL	2006-09-06	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077500-001	LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	2MG;125MG	TABLET / ORAL	2006-09-06	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077500-001	LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	2MG;125MG	TABLET / ORAL	2006-09-06	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077500-001	LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	2MG;125MG	TABLET / ORAL	2006-09-06	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077500-001	LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	2MG;125MG	TABLET / ORAL	2006-09-06	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A077500-001	LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	2MG;125MG	TABLET / ORAL	2006-09-06	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A077500-001	LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	2MG;125MG	TABLET / ORAL	2006-09-06	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077500-001	LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	2MG;125MG	TABLET / ORAL	2006-09-06	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A077500-001	LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	2MG;125MG	TABLET / ORAL	2006-09-06	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A077500-001	LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	2MG;125MG	TABLET / ORAL	2006-09-06	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A077500-001	LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	2MG;125MG	TABLET / ORAL	2006-09-06	`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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Loperamide HCl and Simethicone	LOPERAMIDE HCL AND SIMETHICONE	Ohm Laboratories Inc.	06f99f59-e702-49f1-bb1d-e7cf58c54c30	2022-08-30	Warnings	Exact identifier application applno (ANDA): 077500 application number: ANDA077500 ndc (product): 51660-069

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
51660-069	Loperamide HCl and Simethicone	Loperamide HCl and Simethicone	Ohm Laboratories Inc.	ANDA	Current
51660-069	Loperamide HCl and Simethicone	Loperamide HCl and Simethicone	Ohm Laboratories Inc.	ANDA	Current
51660-069	Loperamide HCl and Simethicone	Loperamide HCl and Simethicone	Ohm Laboratories Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
9054	ORIG	2006-09-15