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 2 of 7 · 132 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
berkley and jensen anti diarrheal	LOPERAMIDE HYDROCHLORIDE	BJWC	dc29a8e9-f916-49d2-b9a6-d2b4537d7b58	2026-05-08	Warnings	Name fallback generic name: LOPERAMIDE HYDROCHLORIDE
MEDIQUE Diamode	LOPERAMIDE HYDROCHLORIDE	Sportpharm LLC	ac674e5a-94df-4a35-9854-4e66cc17e509	2026-04-24	Warnings	Name fallback generic name: LOPERAMIDE HYDROCHLORIDE
Anti-Diarrheal	LOPERAMIDE HYDROCHLORIDE	IMO-GEN LABS LLC	1b5f2c7c-baf0-b213-e063-6394a90a25df	2026-04-21	Warnings	Name fallback generic name: LOPERAMIDE HYDROCHLORIDE
anti-diarrheal	LOPERAMIDE HYDROCHLORIDE	Amazon.com Services LLC	04a35525-ae8e-b41e-e063-6294a90ab10e	2026-04-20	Warnings	Name fallback generic name: LOPERAMIDE HYDROCHLORIDE
loperamide hydrochloride	LOPERAMIDE HCL	Meijer Distribution Inc	5f693cf6-dced-425f-b25e-37a9f8ec17d6	2026-04-06	Warnings	Name fallback brand name: loperamide hydrochloride
Loperamide Hydrochloride	LOPERAMIDE HYDROCHLORIDE	DOLGENCORP INC	4db35031-f765-39a6-e063-6394a90a40c9	2026-03-20	Warnings	Name fallback brand name: Loperamide Hydrochloride generic name: LOPERAMIDE HYDROCHLORIDE
Loperamide Hydrochloride	LOPERAMIDE HYDROCHLORIDE	Safecor Health LLC	8b0ac05b-90c1-476b-b001-5801dd21701d	2026-03-19	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Loperamide Hydrochloride generic name: LOPERAMIDE HYDROCHLORIDE
Anti-Diarrheal	LOPERAMIDE HYDROCHLORIDE	CVS Pharmacy, Inc.	60bc8f05-f35e-45e0-ba3b-c82a87d60f5b	2026-02-27	Warnings	Name fallback generic name: LOPERAMIDE HYDROCHLORIDE
Loperamide Hydrochloride	LOPERAMIDE HYDROCHLORIDE ORAL	Bionpharma Inc.	4bd0939e-c172-d962-e063-6394a90a44b5	2026-02-27	Warnings	Name fallback brand name: Loperamide Hydrochloride
Loperamide Hydrochloride	LOPERAMIDE HYDROCHLORIDE	Golden State Medical Supply, Inc.	396f7e13-b357-52be-e063-6394a90a92fc	2026-02-24	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Loperamide Hydrochloride generic name: LOPERAMIDE HYDROCHLORIDE
loperamide hydrochloride	LOPERAMIDE HCL	Major Pharmaceuticals	cf5dc855-f0cc-4d7e-8d15-472f7e654409	2026-02-13	Warnings	Name fallback brand name: loperamide hydrochloride
Good Sense anti diarrheal	LOPERAMIDE HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	803f492d-183d-423f-b05c-48f06dc9f2a5	2026-01-19	Warnings	Name fallback generic name: LOPERAMIDE HYDROCHLORIDE
anti diarrheal	LOPERAMIDE HYDROCHLORIDE	HyVee Inc	9434cefe-6b13-47c4-b2f7-b8d566c5a4ff	2026-01-13	Warnings	Name fallback generic name: LOPERAMIDE HYDROCHLORIDE
Loperamide Hydrochloride	LOPERAMIDE HYDROCHLORIDE	Advagen Pharma Ltd.,	03c907d5-87f8-47a6-9544-5a24f5272739	2026-01-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Loperamide Hydrochloride generic name: LOPERAMIDE HYDROCHLORIDE
Good Sense anti diarrheal	LOPERAMIDE HYDROCHLORIDE	Northwind Health Company, LLC	db47cc0a-e301-0310-e053-2a95a90a7f5d	2026-01-01	Warnings	Name fallback generic name: LOPERAMIDE HYDROCHLORIDE
anti diarrheal	LOPERAMIDE HYDROCHLORIDE	Publix Super Markets Inc	44773392-eac8-48b3-ae46-b27f5fe55d8d	2025-12-28	Warnings	Name fallback generic name: LOPERAMIDE HYDROCHLORIDE
Imodium A-D	LOPERAMIDE HYDROCHLORIDE	Kenvue Brands LLC	31bfcbb4-c58c-4edc-ac68-356a448b7507	2025-12-22	Warnings	Name fallback generic name: LOPERAMIDE HYDROCHLORIDE
Loperamide Hydrochloride	LOPERAMIDE HYDROCHLORIDE	Edenbridge Pharmaceuticals LLC.	d92819f1-d02d-4959-a019-17d44df6ed2f	2025-12-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Loperamide Hydrochloride generic name: LOPERAMIDE HYDROCHLORIDE
Anti-Diarrheal	LOPERAMIDE HYDROCHLORIDE	WALGREENS	50814751-8bee-4768-bf6c-e9da3400090b	2025-12-15	Warnings	Name fallback generic name: LOPERAMIDE HYDROCHLORIDE
topcare anti diarrheal	LOPERAMIDE HYDROCHLORIDE	Topco Associates LLC	da347b47-d8a5-4cf9-9579-79e6fe57fed5	2025-12-13	Warnings	Name fallback generic name: LOPERAMIDE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

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