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 7 of 7 · 132 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Anti-Diarrheal	LOPERAMIDE HYDROCHLORIDE	DOLGENCORP, LLC	d1fd9a92-9d96-4921-b789-c1f710ee2351	2022-06-03	Warnings	Name fallback generic name: LOPERAMIDE HYDROCHLORIDE
Anti-Diarrheal	LOPERAMIDE HYDROCHLORIDE	Rite Aid Corporation	9cee17ca-bd11-3d40-e053-2995a90ac8fe	2022-05-24	Warnings	Name fallback generic name: LOPERAMIDE HYDROCHLORIDE
Anti-Diarrheal	LOPERAMIDE HYDROCHLORIDE	Strategic Sourcing Services LLC	1537febf-2816-438b-979a-8c8f16f06de5	2022-05-24	Warnings	Name fallback generic name: LOPERAMIDE HYDROCHLORIDE
Anti-Diarrheal	LOPERAMIDE HYDROCHLORIDE	HEB	3ea49be2-1744-4d14-bc43-09d35fd4b3c7	2022-05-19	Warnings	Name fallback generic name: LOPERAMIDE HYDROCHLORIDE
Loperamide Hydrochloride	LOPERAMIDE HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	4d69532c-c71a-4880-9f74-4b37d912cabd	2022-05-11	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Loperamide Hydrochloride generic name: LOPERAMIDE HYDROCHLORIDE
Loperamide Hydrochloride	LOPERAMIDE HYDROCHLORIDE	Proficient Rx LP	82e65393-25b7-4114-9c71-5840ee8bad84	2022-05-02	Warnings	Name fallback brand name: Loperamide Hydrochloride generic name: LOPERAMIDE HYDROCHLORIDE
Loperamide Hydrochloride	LOPERAMIDE HYDROCHLORIDE	Aurohealth LLC	93ebbb23-a9f0-4519-9793-c9056be39f23	2022-03-22	Warnings	Name fallback brand name: Loperamide Hydrochloride generic name: LOPERAMIDE HYDROCHLORIDE
Anti-Diarrheal	LOPERAMIDE HYDROCHLORIDE	AMERISOURCE BERGEN	1a8f6a42-e74f-4725-b12e-b85c2d015191	2022-03-16	Warnings	Name fallback generic name: LOPERAMIDE HYDROCHLORIDE
WELMATE Anti Diarrheal Loperamide HCl	LOPERAMIDE HYDROCHLORIDE	YYBA CORP	ae2e006c-0347-6c35-e053-2a95a90ab7b1	2020-08-31	Warnings	Name fallback generic name: LOPERAMIDE HYDROCHLORIDE
Good Sense anti diarrheal	LOPERAMIDE HYDROCHLORIDE	Proficient Rx LP	345be8d9-4fc9-40a2-a9f3-775d48beb85b	2019-10-01	Warnings	Name fallback generic name: LOPERAMIDE HYDROCHLORIDE
anti-diarrheal	LOPERAMIDE HYDROCHLORIDE	Bionpharma Inc.	8f1ee652-a4f7-4e5b-874f-46aa641cd43f	2019-09-09	Warnings	Name fallback generic name: LOPERAMIDE HYDROCHLORIDE
Loperamide Hydrochloride	LOPERAMIDE HYDROCHLORIDE	Teva Pharmaceuticals USA, Inc.	8bf47ac3-746f-47c3-82b2-32ac979ff963	2016-11-30	Boxed warning, Warnings, Adverse reactions	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.