Application 217840

Type: ANDA
Sponsor: JUBILANT CADISTA

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
A217840-001	LOPERAMIDE HYDROCHLORIDE	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB		2023-07-05

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A217840-001	AB

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	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A217840-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	2023-07-05	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A217840-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	2023-07-05	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A217840-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	2023-07-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217840-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	2023-07-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A217840-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	2023-07-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217840-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	2023-07-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217840-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	2023-07-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217840-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	2023-07-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217840-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	2023-07-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217840-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	2023-07-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217840-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	2023-07-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A217840-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	2023-07-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217840-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	2023-07-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A217840-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	2023-07-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A217840-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	2023-07-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A217840-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	2023-07-05	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A217840-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	2023-07-05	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A217840-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	2023-07-05	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A217840-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	2023-07-05	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A217840-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	2023-07-05	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A217840-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	2023-07-05	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A217840-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	2023-07-05	`a67488948f0b…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A217840-001	LOPERAMIDE HYDROCHLORIDE	2MG	CAPSULE / ORAL	AB	2023-07-05	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A217840-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A217840-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A217840-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217840-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A217840-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217840-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217840-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217840-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217840-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217840-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217840-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A217840-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217840-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A217840-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A217840-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A217840-001	AB	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A217840-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A217840-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A217840-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A217840-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A217840-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A217840-001	AB	1	`a67488948f0b…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A217840-001	AB	1	`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 5 of 7 · 132 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Loperamide Hydrochloride	LOPERAMIDE HYDROCHLORIDE	NuCare Pharmaceuticals, Inc.	3e898141-8d40-49f1-e054-00144ff88e88	2024-08-13	Warnings, Adverse reactions	Name fallback brand name: Loperamide Hydrochloride generic name: LOPERAMIDE HYDROCHLORIDE
Anti-Diarrheal	LOPERAMIDE HYDROCHLORIDE	Advanced Rx LLC	287bd6d9-aa29-4f56-9c7f-5cbacbf62537	2024-08-11	Warnings	Name fallback generic name: LOPERAMIDE HYDROCHLORIDE
Loperamide Hydrochloride	LOPERAMIDE HYDROCHLORIDE	NCS HealthCare of KY, LLC dba Vangard Labs	f245e8f4-e06e-492e-8c46-af1fce1633fc	2024-08-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Loperamide Hydrochloride generic name: LOPERAMIDE HYDROCHLORIDE
Loperamide Hydrochloride	LOPERAMIDE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	af0b886f-c065-26dc-e053-2995a90ac471	2024-07-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Loperamide Hydrochloride generic name: LOPERAMIDE HYDROCHLORIDE
loperamide hydrochloride	LOPERAMIDE HCL	Rite Aid Corporation	56334ed4-8cb0-4f5c-9051-6836f0e21337	2024-06-28	Warnings	Name fallback brand name: loperamide hydrochloride
anti diarrheal	LOPERAMIDE HYDROCHLORIDE	Meijer Distribution Inc	06a0530b-b06a-466b-b366-82a2a9f7c05c	2024-06-19	Warnings	Name fallback generic name: LOPERAMIDE HYDROCHLORIDE
Anti-Diarrheal	LOPERAMIDE HYDROCHLORIDE	CARDINAL HEALTH	bd58d6e9-628c-4c6b-b44c-da95e0417ba7	2024-05-31	Warnings	Name fallback generic name: LOPERAMIDE HYDROCHLORIDE
AMAZON BASIC CARE LOPERAMIDE HYDROCHLORIDE	LOPERAMIDE HYDROCHLORIDE	Amazon.com Services LLC	10edd7bc-fc35-abe3-e063-6394a90aeb3f	2024-05-15	Warnings	Name fallback generic name: LOPERAMIDE HYDROCHLORIDE
Loperamide Hydrochloride	LOPERAMIDE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	df4e7076-fd25-aeb8-e053-2995a90a2aa0	2024-05-07	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Loperamide Hydrochloride generic name: LOPERAMIDE HYDROCHLORIDE
Anti-Diarrheal	LOPERAMIDE HYDROCHLORIDE	SDA Laboratories, Inc.	d954ff63-f096-45e8-a0b6-f22e323b113f	2024-04-18	Warnings	Name fallback generic name: LOPERAMIDE HYDROCHLORIDE
Loperamide Hydrochloride	LOPERAMIDE HYDROCHLORIDE	Bryant Ranch Prepack	691c5dd6-b85d-482b-a8c1-8c4b48b48dc9	2024-04-03	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Loperamide Hydrochloride generic name: LOPERAMIDE HYDROCHLORIDE
Loperamide Hydrochloride	LOPERAMIDE HYDROCHLORIDE	Amerisource Bergen	6c15f077-9f90-4262-9c17-a1ac70e45f57	2024-03-29	Warnings	Name fallback brand name: Loperamide Hydrochloride generic name: LOPERAMIDE HYDROCHLORIDE
Loperamide Hydrochloride	LOPERAMIDE HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	c5322892-cb14-4a25-9b42-e62e491bc101	2024-02-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Loperamide Hydrochloride generic name: LOPERAMIDE HYDROCHLORIDE
Loperamide Hydrochloride	LOPERAMIDE HYDROCHLORIDE	Chain Drug Consortium, LLC	b070896b-1e22-41d4-a66d-8d3be1699217	2024-01-11	Warnings	Name fallback brand name: Loperamide Hydrochloride generic name: LOPERAMIDE HYDROCHLORIDE
Loperamide Hydrochloride	LOPERAMIDE HYDROCHLORIDE	Zee Medical Inc	07e1f89c-5bf6-4539-848a-4435e7deb0d2	2024-01-11	Warnings	Name fallback brand name: Loperamide Hydrochloride generic name: LOPERAMIDE HYDROCHLORIDE
Loperamide Hydrochloride	LOPERAMIDE HYDROCHLORIDE	Ohm Laboratories Inc.	c26c15a1-3a8a-4562-8c5e-ebbc8b81e0c6	2024-01-11	Warnings	Name fallback brand name: Loperamide Hydrochloride generic name: LOPERAMIDE HYDROCHLORIDE
Loperamide Hydrochloride	LOPERAMIDE HYDROCHLORIDE	Discount Drug Mart	6bc9771d-09f8-47ce-bbbd-8dd9aae97693	2024-01-11	Warnings	Name fallback brand name: Loperamide Hydrochloride generic name: LOPERAMIDE HYDROCHLORIDE
Loperamide Hydrochloride	LOPERAMIDE HYDROCHLORIDE	Marc Glassman, Inc.	01efdce1-25ce-45ff-aeb6-f6fba00e59aa	2024-01-11	Warnings	Name fallback brand name: Loperamide Hydrochloride generic name: LOPERAMIDE HYDROCHLORIDE
Loperamide Hydrochloride	LOPERAMIDE HYDROCHLORIDE	Valu Merchandisers Company	33335063-49a9-4e08-9d77-4cd80e94f021	2024-01-11	Warnings	Name fallback brand name: Loperamide Hydrochloride generic name: LOPERAMIDE HYDROCHLORIDE
Loperamide Hydrochloride	LOPERAMIDE HYDROCHLORIDE	Fred's Inc.	a3bf91ae-22f3-4402-b73c-de026f2d0475	2024-01-11	Warnings	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.