Home Applications 077605 Application 077605
Type ANDA
Sponsor BARR 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 43 .
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 A077605-001 GALANTAMINE HYDROBROMIDE GALANTAMINE HYDROBROMIDE EQ 4MG BASE TABLET / ORAL AB 2008-08-28 A077605-002 GALANTAMINE HYDROBROMIDE GALANTAMINE HYDROBROMIDE EQ 8MG BASE TABLET / ORAL AB 2008-08-28 A077605-003 GALANTAMINE HYDROBROMIDE GALANTAMINE HYDROBROMIDE EQ 12MG BASE TABLET / ORAL AB 2008-08-28
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 · 129 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 2026-09-14 22:38:34 2026-08 A077605-001 GALANTAMINE HYDROBROMIDE EQ 4MG BASE TABLET / ORAL AB 2008-08-28 84e616aacf4f…2026-09-14 22:38:34 2026-08 A077605-002 GALANTAMINE HYDROBROMIDE EQ 8MG BASE TABLET / ORAL AB 2008-08-28 84e616aacf4f…2026-09-14 22:38:34 2026-08 A077605-003 GALANTAMINE HYDROBROMIDE EQ 12MG BASE TABLET / ORAL AB 2008-08-28 84e616aacf4f…2026-08-18 06:07:40 2026-07 A077605-001 GALANTAMINE HYDROBROMIDE EQ 4MG BASE TABLET / ORAL AB 2008-08-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077605-002 GALANTAMINE HYDROBROMIDE EQ 8MG BASE TABLET / ORAL AB 2008-08-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077605-003 GALANTAMINE HYDROBROMIDE EQ 12MG BASE TABLET / ORAL AB 2008-08-28 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A077605-001 GALANTAMINE HYDROBROMIDE EQ 4MG BASE TABLET / ORAL AB 2008-08-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077605-002 GALANTAMINE HYDROBROMIDE EQ 8MG BASE TABLET / ORAL AB 2008-08-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077605-003 GALANTAMINE HYDROBROMIDE EQ 12MG BASE TABLET / ORAL AB 2008-08-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077605-001 GALANTAMINE HYDROBROMIDE EQ 4MG BASE TABLET / ORAL AB 2008-08-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077605-002 GALANTAMINE HYDROBROMIDE EQ 8MG BASE TABLET / ORAL AB 2008-08-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077605-003 GALANTAMINE HYDROBROMIDE EQ 12MG BASE TABLET / ORAL AB 2008-08-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A077605-001 GALANTAMINE HYDROBROMIDE EQ 4MG BASE TABLET / ORAL AB 2008-08-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077605-002 GALANTAMINE HYDROBROMIDE EQ 8MG BASE TABLET / ORAL AB 2008-08-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077605-003 GALANTAMINE HYDROBROMIDE EQ 12MG BASE TABLET / ORAL AB 2008-08-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077605-001 GALANTAMINE HYDROBROMIDE EQ 4MG BASE TABLET / ORAL AB 2008-08-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077605-002 GALANTAMINE HYDROBROMIDE EQ 8MG BASE TABLET / ORAL AB 2008-08-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077605-003 GALANTAMINE HYDROBROMIDE EQ 12MG BASE TABLET / ORAL AB 2008-08-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077605-001 GALANTAMINE HYDROBROMIDE EQ 4MG BASE TABLET / ORAL AB 2008-08-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077605-002 GALANTAMINE HYDROBROMIDE EQ 8MG BASE TABLET / ORAL AB 2008-08-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077605-003 GALANTAMINE HYDROBROMIDE EQ 12MG BASE TABLET / ORAL AB 2008-08-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077605-001 GALANTAMINE HYDROBROMIDE EQ 4MG BASE TABLET / ORAL AB 2008-08-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077605-002 GALANTAMINE HYDROBROMIDE EQ 8MG BASE TABLET / ORAL AB 2008-08-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077605-003 GALANTAMINE HYDROBROMIDE EQ 12MG BASE TABLET / ORAL AB 2008-08-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077605-001 GALANTAMINE HYDROBROMIDE EQ 4MG BASE TABLET / ORAL AB 2008-08-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077605-002 GALANTAMINE HYDROBROMIDE EQ 8MG BASE TABLET / ORAL AB 2008-08-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077605-003 GALANTAMINE HYDROBROMIDE EQ 12MG BASE TABLET / ORAL AB 2008-08-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077605-001 GALANTAMINE HYDROBROMIDE EQ 4MG BASE TABLET / ORAL AB 2008-08-28 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077605-002 GALANTAMINE HYDROBROMIDE EQ 8MG BASE TABLET / ORAL AB 2008-08-28 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077605-003 GALANTAMINE HYDROBROMIDE EQ 12MG BASE TABLET / ORAL AB 2008-08-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077605-001 GALANTAMINE HYDROBROMIDE EQ 4MG BASE TABLET / ORAL AB 2008-08-28 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077605-002 GALANTAMINE HYDROBROMIDE EQ 8MG BASE TABLET / ORAL AB 2008-08-28 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077605-003 GALANTAMINE HYDROBROMIDE EQ 12MG BASE TABLET / ORAL AB 2008-08-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A077605-001 GALANTAMINE HYDROBROMIDE EQ 4MG BASE TABLET / ORAL AB 2008-08-28 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A077605-002 GALANTAMINE HYDROBROMIDE EQ 8MG BASE TABLET / ORAL AB 2008-08-28 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A077605-003 GALANTAMINE HYDROBROMIDE EQ 12MG BASE TABLET / ORAL AB 2008-08-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077605-001 GALANTAMINE HYDROBROMIDE EQ 4MG BASE TABLET / ORAL AB 2008-08-28 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077605-002 GALANTAMINE HYDROBROMIDE EQ 8MG BASE TABLET / ORAL AB 2008-08-28 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077605-003 GALANTAMINE HYDROBROMIDE EQ 12MG BASE TABLET / ORAL AB 2008-08-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077605-001 GALANTAMINE HYDROBROMIDE EQ 4MG BASE TABLET / ORAL AB 2008-08-28 301d65b070ca…
Observed Orange Book normalized TE history# Normalized TE history page 2 of 4 · 129 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
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Documents# Document, Submission type, Date table Document Submission type Date 39535 ORIG 2008-11-20 23876 ORIG 2008-09-19 31264 ORIG 2008-08-29