Home Applications 078898 Application 078898
Type ANDA
Sponsor ZYDUS PHARMS USA INC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 GALANTAMINE HYDROBROMIDE GALANTAMINE HYDROBROMIDE TABLET;ORAL EQ 4MG BASE No No 002 GALANTAMINE HYDROBROMIDE GALANTAMINE HYDROBROMIDE TABLET;ORAL EQ 8MG BASE No No 003 GALANTAMINE HYDROBROMIDE GALANTAMINE HYDROBROMIDE TABLET;ORAL EQ 12MG BASE No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A078898-001 GALANTAMINE HYDROBROMIDE GALANTAMINE HYDROBROMIDE EQ 4MG BASE TABLET / ORAL AB 2011-02-17 A078898-002 GALANTAMINE HYDROBROMIDE GALANTAMINE HYDROBROMIDE EQ 8MG BASE TABLET / ORAL AB 2011-02-17 A078898-003 GALANTAMINE HYDROBROMIDE GALANTAMINE HYDROBROMIDE EQ 12MG BASE TABLET / ORAL AB 2011-02-17
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 matching rows.
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 4 · 123 observed 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 2026-02-19 14:30 UTC 2026-02 A078898-001 GALANTAMINE HYDROBROMIDE EQ 4MG BASE TABLET / ORAL AB 2011-02-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078898-002 GALANTAMINE HYDROBROMIDE EQ 8MG BASE TABLET / ORAL AB 2011-02-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078898-003 GALANTAMINE HYDROBROMIDE EQ 12MG BASE TABLET / ORAL AB 2011-02-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078898-001 GALANTAMINE HYDROBROMIDE EQ 4MG BASE TABLET / ORAL AB 2011-02-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078898-002 GALANTAMINE HYDROBROMIDE EQ 8MG BASE TABLET / ORAL AB 2011-02-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078898-003 GALANTAMINE HYDROBROMIDE EQ 12MG BASE TABLET / ORAL AB 2011-02-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A078898-001 GALANTAMINE HYDROBROMIDE EQ 4MG BASE TABLET / ORAL AB 2011-02-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078898-002 GALANTAMINE HYDROBROMIDE EQ 8MG BASE TABLET / ORAL AB 2011-02-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078898-003 GALANTAMINE HYDROBROMIDE EQ 12MG BASE TABLET / ORAL AB 2011-02-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078898-001 GALANTAMINE HYDROBROMIDE EQ 4MG BASE TABLET / ORAL AB 2011-02-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078898-002 GALANTAMINE HYDROBROMIDE EQ 8MG BASE TABLET / ORAL AB 2011-02-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078898-003 GALANTAMINE HYDROBROMIDE EQ 12MG BASE TABLET / ORAL AB 2011-02-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078898-001 GALANTAMINE HYDROBROMIDE EQ 4MG BASE TABLET / ORAL AB 2011-02-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078898-002 GALANTAMINE HYDROBROMIDE EQ 8MG BASE TABLET / ORAL AB 2011-02-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078898-003 GALANTAMINE HYDROBROMIDE EQ 12MG BASE TABLET / ORAL AB 2011-02-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078898-001 GALANTAMINE HYDROBROMIDE EQ 4MG BASE TABLET / ORAL AB 2011-02-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078898-002 GALANTAMINE HYDROBROMIDE EQ 8MG BASE TABLET / ORAL AB 2011-02-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078898-003 GALANTAMINE HYDROBROMIDE EQ 12MG BASE TABLET / ORAL AB 2011-02-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078898-001 GALANTAMINE HYDROBROMIDE EQ 4MG BASE TABLET / ORAL AB 2011-02-17 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078898-002 GALANTAMINE HYDROBROMIDE EQ 8MG BASE TABLET / ORAL AB 2011-02-17 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078898-003 GALANTAMINE HYDROBROMIDE EQ 12MG BASE TABLET / ORAL AB 2011-02-17 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078898-001 GALANTAMINE HYDROBROMIDE EQ 4MG BASE TABLET / ORAL AB 2011-02-17 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078898-002 GALANTAMINE HYDROBROMIDE EQ 8MG BASE TABLET / ORAL AB 2011-02-17 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078898-003 GALANTAMINE HYDROBROMIDE EQ 12MG BASE TABLET / ORAL AB 2011-02-17 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078898-001 GALANTAMINE HYDROBROMIDE EQ 4MG BASE TABLET / ORAL AB 2011-02-17 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078898-002 GALANTAMINE HYDROBROMIDE EQ 8MG BASE TABLET / ORAL AB 2011-02-17 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078898-003 GALANTAMINE HYDROBROMIDE EQ 12MG BASE TABLET / ORAL AB 2011-02-17 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A078898-001 GALANTAMINE HYDROBROMIDE EQ 4MG BASE TABLET / ORAL AB 2011-02-17 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A078898-002 GALANTAMINE HYDROBROMIDE EQ 8MG BASE TABLET / ORAL AB 2011-02-17 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A078898-003 GALANTAMINE HYDROBROMIDE EQ 12MG BASE TABLET / ORAL AB 2011-02-17 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078898-001 GALANTAMINE HYDROBROMIDE EQ 4MG BASE TABLET / ORAL AB 2011-02-17 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078898-002 GALANTAMINE HYDROBROMIDE EQ 8MG BASE TABLET / ORAL AB 2011-02-17 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078898-003 GALANTAMINE HYDROBROMIDE EQ 12MG BASE TABLET / ORAL AB 2011-02-17 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078898-001 GALANTAMINE HYDROBROMIDE EQ 4MG BASE TABLET / ORAL AB 2011-02-17 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078898-002 GALANTAMINE HYDROBROMIDE EQ 8MG BASE TABLET / ORAL AB 2011-02-17 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078898-003 GALANTAMINE HYDROBROMIDE EQ 12MG BASE TABLET / ORAL AB 2011-02-17 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078898-001 GALANTAMINE HYDROBROMIDE EQ 4MG BASE TABLET / ORAL AB 2011-02-17 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078898-002 GALANTAMINE HYDROBROMIDE EQ 8MG BASE TABLET / ORAL AB 2011-02-17 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078898-003 GALANTAMINE HYDROBROMIDE EQ 12MG BASE TABLET / ORAL AB 2011-02-17 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A078898-001 GALANTAMINE HYDROBROMIDE EQ 4MG BASE TABLET / ORAL AB 2011-02-17 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 123 observed states.
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 · 8 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Galantamine Hydrobromide GALANTAMINE HYDROBROMIDE Bryant Ranch Prepack 0f74a146-f6ee-4910-82a3-177153526dd0 2025-09-12 Warnings, Adverse reactions Name fallback brand name: Galantamine Hydrobromide generic name: GALANTAMINE HYDROBROMIDE Galantamine Hydrobromide GALANTAMINE HYDROBROMIDE Bryant Ranch Prepack 3059d10f-fb3d-4cbd-b936-104608889b67 2024-08-12 Warnings, Adverse reactions Name fallback brand name: Galantamine Hydrobromide generic name: GALANTAMINE HYDROBROMIDE Galantamine Hydrobromide GALANTAMINE HYDROBROMIDE Bryant Ranch Prepack db5b6c1e-449b-413f-b0cc-ca2133aa4986 2024-08-12 Warnings, Adverse reactions Name fallback brand name: Galantamine Hydrobromide generic name: GALANTAMINE HYDROBROMIDE Galantamine Hydrobromide GALANTAMINE HYDROBROMIDE Bryant Ranch Prepack 3e7e2839-a834-4464-a82a-7554e10ad004 2024-08-12 Warnings, Adverse reactions Name fallback brand name: Galantamine Hydrobromide generic name: GALANTAMINE HYDROBROMIDE Galantamine Hydrobromide GALANTAMINE HYDROBROMIDE Bryant Ranch Prepack 5cd99bc0-0f18-4800-a0f5-a94eebf0eead 2024-04-08 Warnings, Adverse reactions Name fallback brand name: Galantamine Hydrobromide generic name: GALANTAMINE HYDROBROMIDE Galantamine Hydrobromide GALANTAMINE HYDROBROMIDE Bryant Ranch Prepack c44108aa-bf20-4d45-b36f-d117320a675b 2024-04-08 Warnings, Adverse reactions Name fallback brand name: Galantamine Hydrobromide generic name: GALANTAMINE HYDROBROMIDE Galantamine Hydrobromide GALANTAMINE HYDROBROMIDE Sun Pharmaceutical Industries, Inc. d1697161-ebe8-42b0-83e7-c9de4412546c 2023-10-26 Warnings, Adverse reactions Name fallback brand name: Galantamine Hydrobromide generic name: GALANTAMINE HYDROBROMIDE Galantamine Hydrobromide GALANTAMINE HYDROBROMIDE Hikma Pharmaceuticals USA Inc. d5b0e225-e94d-4324-afb2-b6e51c949dd0 2023-10-25 Warnings, Adverse reactions Name fallback brand name: Galantamine Hydrobromide generic name: GALANTAMINE HYDROBROMIDE
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 24 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 65841-755 Galantamine Galantamine Zydus Lifesciences Limited ANDA Current 65841-755 Galantamine Galantamine Cadila Healthcare Limited ANDA Current 65841-755 Galantamine Galantamine Cadila Healthcare Limited ANDA Current 65841-755 Galantamine Galantamine Cadila Healthcare Limited ANDA Current 65841-756 Galantamine Galantamine Zydus Lifesciences Limited ANDA Current 65841-756 Galantamine Galantamine Cadila Healthcare Limited ANDA Current 65841-756 Galantamine Galantamine Cadila Healthcare Limited ANDA Current 65841-756 Galantamine Galantamine Cadila Healthcare Limited ANDA Current 65841-757 Galantamine Galantamine Zydus Lifesciences Limited ANDA Current 65841-757 Galantamine Galantamine Cadila Healthcare Limited ANDA Current 65841-757 Galantamine Galantamine Cadila Healthcare Limited ANDA Current 65841-757 Galantamine Galantamine Cadila Healthcare Limited ANDA Current 68382-177 galantamine galantamine Zydus Pharmaceuticals (USA) Inc. ANDA Current 68382-177 galantamine galantamine Zydus Pharmaceuticals (USA) Inc. ANDA Current 68382-177 galantamine galantamine Zydus Pharmaceuticals USA Inc. ANDA Current 68382-177 galantamine galantamine Zydus Pharmaceuticals (USA) Inc. ANDA Current 68382-178 galantamine galantamine Zydus Pharmaceuticals (USA) Inc. ANDA Current 68382-178 galantamine galantamine Zydus Pharmaceuticals (USA) Inc. ANDA Current 68382-178 galantamine galantamine Zydus Pharmaceuticals USA Inc. ANDA Current 68382-178 galantamine galantamine Zydus Pharmaceuticals (USA) Inc. ANDA Current 68382-179 galantamine galantamine Zydus Pharmaceuticals (USA) Inc. ANDA Current 68382-179 galantamine galantamine Zydus Pharmaceuticals (USA) Inc. ANDA Current 68382-179 galantamine galantamine Zydus Pharmaceuticals USA Inc. ANDA Current 68382-179 galantamine galantamine Zydus Pharmaceuticals (USA) Inc. ANDA Current