Home Applications 217840 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 RLD / RS 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# 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 6 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 Chain Drug Marketing Association Inc. 237b845b-0f02-410d-9750-c95123e6142d 2024-01-11 Warnings Name fallback brand name: Loperamide Hydrochloride generic name: LOPERAMIDE HYDROCHLORIDE Loperamide Hydrochloride LOPERAMIDE HYDROCHLORIDE Bionpharma Inc. 6e60cb25-6af9-4f17-b740-a5e7b5bb2a09 2023-12-27 Boxed warning, Warnings, Adverse reactions Name fallback brand name: Loperamide Hydrochloride generic name: LOPERAMIDE HYDROCHLORIDE anti-diarrheal LOPERAMIDE HYDROCHLORIDE Bionpharma Inc. a14bd404-cc79-06e0-e053-2a95a90a6841 2023-12-26 Warnings Name fallback generic name: LOPERAMIDE HYDROCHLORIDE anti-diarrheal LOPERAMIDE HYDROCHLORIDE VALU MERCHANDISERS COMPANY fed347ad-cfbb-9ee8-e053-6394a90ad275 2023-10-10 Warnings Name fallback generic name: LOPERAMIDE HYDROCHLORIDE LOPERAMIDE HYDROCHLORIDE LOPERAMIDE HYDROCHLORIDE Aurobindo Pharma Limited 8d142533-4e87-4030-8fe9-4fc7473b0442 2023-09-11 Boxed warning, Warnings, Adverse reactions Name fallback brand name: LOPERAMIDE HYDROCHLORIDE generic name: LOPERAMIDE HYDROCHLORIDE Loperamide Hydrochloride LOPERAMIDE HYDROCHLORIDE Dr. Reddy's Laboratories Inc. 6fe91ddc-06b6-3a51-2b48-f6f11361ab73 2023-06-25 Warnings Name fallback brand name: Loperamide Hydrochloride generic name: LOPERAMIDE HYDROCHLORIDE Loperamide Hydrochloride LOPERAMIDE HYDROCHLORIDE Dr. Reddy's Laboratories Inc. 356d9432-d948-4b88-b297-9161b845f86b 2023-06-25 Warnings Name fallback brand name: Loperamide Hydrochloride generic name: LOPERAMIDE HYDROCHLORIDE Loperamide hydrochloride LOPERAMIDE HYDROCHLORIDE Viona Pharmaceuticals Inc 330677ff-5426-40bd-af45-e3836cb77893 2023-06-19 Boxed warning, Warnings, Adverse reactions Name fallback brand name: Loperamide hydrochloride generic name: LOPERAMIDE HYDROCHLORIDE Loperamide hydrochloride LOPERAMIDE HYDROCHLORIDE Zydus Lifesciences Limited 5d13405c-8fd7-454f-9b49-3d8b9ef672b8 2023-06-19 Name fallback brand name: Loperamide hydrochloride generic name: LOPERAMIDE HYDROCHLORIDE Loperamide Hydrochloride LOPERAMIDE HYDROCHLORIDE Bryant Ranch Prepack f092b8a5-80b0-40ba-af45-2ac9edaa7704 2023-05-24 Boxed warning, Warnings, Adverse reactions Name fallback brand name: Loperamide Hydrochloride generic name: LOPERAMIDE HYDROCHLORIDE Anti-Diarrheal LOPERAMIDE HYDROCHLORIDE STRATEGIC SOURCING SERVICES f9e03d2b-2ec0-322b-e053-6394a90a1599 2023-04-21 Warnings Name fallback generic name: LOPERAMIDE HYDROCHLORIDE Handy Solutions Anti-Diarrheal LOPERAMIDE HYDROCHLORIDE Navajo Manufacturing Company Inc. 76e32e66-4af5-47a5-83ff-cbba206975d6 2023-03-15 Warnings Name fallback generic name: LOPERAMIDE HYDROCHLORIDE Loperamide Hydrochloride LOPERAMIDE HYDROCHLORIDE allphamed Pharbil Arzneimittel GmbH a8c8d1d2-a8c7-462a-b620-729a9baa93c4 2023-02-22 Boxed warning, Warnings, Adverse reactions Name fallback brand name: Loperamide Hydrochloride generic name: LOPERAMIDE HYDROCHLORIDE Anti-Diarrheal LOPERAMIDE HYDROCHLORIDE TOP CARE (Topco Associates LLC) c62bc8d4-0857-16fc-e053-2a95a90a0c41 2022-12-30 Warnings Name fallback generic name: LOPERAMIDE HYDROCHLORIDE ANTI-DIARRHEAL LOPERAMIDE HYDROCHLORIDE Northeast Pharma c2db4155-68d4-71be-e053-2a95a90a7f35 2022-12-30 Warnings Name fallback generic name: LOPERAMIDE HYDROCHLORIDE Anti-Diarrheal LOPERAMIDE HYDROCHLORIDE Premier Value Alliance LLC 0dd97bfb-67ce-472f-9b23-15f613bb3135 2022-12-29 Warnings Name fallback generic name: LOPERAMIDE HYDROCHLORIDE Anti-Diarrheal LOPERAMIDE HYDROCHLORIDE Wal-Mart Stores, Inc. 507acd63-b2b4-465e-bb94-2d66724de20a 2022-12-29 Warnings Name fallback generic name: LOPERAMIDE HYDROCHLORIDE Anti-Diarrheal LOPERAMIDE HYDROCHLORIDE CHAIN DRUG MARKETING ASSOCIATION INC. edae1ea7-7a6a-4971-8a21-c2b508e96f4e 2022-12-21 Warnings Name fallback generic name: LOPERAMIDE HYDROCHLORIDE WELMATE Anti Diarrheal Loperamide HCl Softgels LOPERAMIDE HYDROCHLORIDE YYBA CORP ae2e15e9-1707-296d-e053-2995a90a1b95 2022-11-01 Warnings Name fallback generic name: LOPERAMIDE HYDROCHLORIDE Loperamide Hydrochloride LOPERAMIDE HYDROCHLORIDE Mylan Pharmaceuticals Inc. 72a7ae47-cdf3-4949-b9f8-f29b153f787f 2022-09-30 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.