Application 079028

Type: ANDA
Sponsor: WATSON LABS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	GALANTAMINE HYDROBROMIDE	GALANTAMINE HYDROBROMIDE	CAPSULE, EXTENDED RELEASE;ORAL	EQ 8MG BASE	No	No
002	GALANTAMINE HYDROBROMIDE	GALANTAMINE HYDROBROMIDE	CAPSULE, EXTENDED RELEASE;ORAL	EQ 16MG BASE	No	No
003	GALANTAMINE HYDROBROMIDE	GALANTAMINE HYDROBROMIDE	CAPSULE, EXTENDED RELEASE;ORAL	EQ 24MG 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	Approval date
A079028-001	GALANTAMINE HYDROBROMIDE	GALANTAMINE HYDROBROMIDE	EQ 8MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2008-12-15
A079028-002	GALANTAMINE HYDROBROMIDE	GALANTAMINE HYDROBROMIDE	EQ 16MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2008-12-15
A079028-003	GALANTAMINE HYDROBROMIDE	GALANTAMINE HYDROBROMIDE	EQ 24MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2008-12-15

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A079028-001	AB
A079028-002	AB
A079028-003	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.

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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A079028-001	GALANTAMINE HYDROBROMIDE	EQ 8MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2008-12-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079028-002	GALANTAMINE HYDROBROMIDE	EQ 16MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2008-12-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079028-003	GALANTAMINE HYDROBROMIDE	EQ 24MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2008-12-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079028-001	GALANTAMINE HYDROBROMIDE	EQ 8MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2008-12-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079028-002	GALANTAMINE HYDROBROMIDE	EQ 16MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2008-12-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079028-003	GALANTAMINE HYDROBROMIDE	EQ 24MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2008-12-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A079028-001	GALANTAMINE HYDROBROMIDE	EQ 8MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2008-12-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079028-002	GALANTAMINE HYDROBROMIDE	EQ 16MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2008-12-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079028-003	GALANTAMINE HYDROBROMIDE	EQ 24MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2008-12-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079028-001	GALANTAMINE HYDROBROMIDE	EQ 8MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2008-12-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079028-002	GALANTAMINE HYDROBROMIDE	EQ 16MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2008-12-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079028-003	GALANTAMINE HYDROBROMIDE	EQ 24MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2008-12-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079028-001	GALANTAMINE HYDROBROMIDE	EQ 8MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2008-12-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079028-002	GALANTAMINE HYDROBROMIDE	EQ 16MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2008-12-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079028-003	GALANTAMINE HYDROBROMIDE	EQ 24MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2008-12-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079028-001	GALANTAMINE HYDROBROMIDE	EQ 8MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2008-12-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079028-002	GALANTAMINE HYDROBROMIDE	EQ 16MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2008-12-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079028-003	GALANTAMINE HYDROBROMIDE	EQ 24MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2008-12-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079028-001	GALANTAMINE HYDROBROMIDE	EQ 8MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2008-12-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079028-002	GALANTAMINE HYDROBROMIDE	EQ 16MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2008-12-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079028-003	GALANTAMINE HYDROBROMIDE	EQ 24MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2008-12-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079028-001	GALANTAMINE HYDROBROMIDE	EQ 8MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2008-12-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079028-002	GALANTAMINE HYDROBROMIDE	EQ 16MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2008-12-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079028-003	GALANTAMINE HYDROBROMIDE	EQ 24MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2008-12-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079028-001	GALANTAMINE HYDROBROMIDE	EQ 8MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2008-12-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079028-002	GALANTAMINE HYDROBROMIDE	EQ 16MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2008-12-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079028-003	GALANTAMINE HYDROBROMIDE	EQ 24MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2008-12-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A079028-001	GALANTAMINE HYDROBROMIDE	EQ 8MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2008-12-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A079028-002	GALANTAMINE HYDROBROMIDE	EQ 16MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2008-12-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A079028-003	GALANTAMINE HYDROBROMIDE	EQ 24MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2008-12-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A079028-001	GALANTAMINE HYDROBROMIDE	EQ 8MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2008-12-15	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A079028-002	GALANTAMINE HYDROBROMIDE	EQ 16MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2008-12-15	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A079028-003	GALANTAMINE HYDROBROMIDE	EQ 24MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2008-12-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A079028-001	GALANTAMINE HYDROBROMIDE	EQ 8MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2008-12-15	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A079028-002	GALANTAMINE HYDROBROMIDE	EQ 16MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2008-12-15	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A079028-003	GALANTAMINE HYDROBROMIDE	EQ 24MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2008-12-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A079028-001	GALANTAMINE HYDROBROMIDE	EQ 8MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2008-12-15	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A079028-002	GALANTAMINE HYDROBROMIDE	EQ 16MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2008-12-15	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A079028-003	GALANTAMINE HYDROBROMIDE	EQ 24MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2008-12-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A079028-001	GALANTAMINE HYDROBROMIDE	EQ 8MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2008-12-15	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A079028-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079028-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079028-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079028-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079028-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079028-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A079028-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079028-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079028-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079028-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079028-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079028-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079028-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079028-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079028-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079028-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079028-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079028-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079028-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079028-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079028-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079028-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079028-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079028-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079028-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079028-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079028-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A079028-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A079028-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A079028-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A079028-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A079028-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A079028-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A079028-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A079028-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A079028-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A079028-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A079028-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A079028-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A079028-001	AB	1	`8072bd15b7f6…`

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 · 22 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0591-3496	Galantamine	Galantamine	Actavis Pharma, Inc.	ANDA	Current
0591-3496	Galantamine	Galantamine	Actavis Pharma, Inc.	ANDA	Current
0591-3496	Galantamine	Galantamine	Actavis Pharma, Inc.	ANDA	Current
0591-3496	Galantamine	Galantamine	Actavis Pharma, Inc.	ANDA	Current
0591-3496	Galantamine	Galantamine	Actavis Pharma, Inc.	ANDA	Current
0591-3496	Galantamine	Galantamine	Actavis Pharma, Inc.	ANDA	Current
0591-3496	Galantamine	Galantamine	Actavis Pharma, Inc.	ANDA	Current
0591-3497	Galantamine	Galantamine	Actavis Pharma, Inc.	ANDA	Current
0591-3497	Galantamine	Galantamine	Actavis Pharma, Inc.	ANDA	Current
0591-3497	Galantamine	Galantamine	Actavis Pharma, Inc.	ANDA	Current
0591-3497	Galantamine	Galantamine	Actavis Pharma, Inc.	ANDA	Current
0591-3497	Galantamine	Galantamine	Actavis Pharma, Inc.	ANDA	Current
0591-3497	Galantamine	Galantamine	Actavis Pharma, Inc.	ANDA	Current
0591-3497	Galantamine	Galantamine	Actavis Pharma, Inc.	ANDA	Current
0591-3498	Galantamine	Galantamine	Actavis Pharma, Inc.	ANDA	Current
0591-3498	Galantamine	Galantamine	Actavis Pharma, Inc.	ANDA	Current
0591-3498	Galantamine	Galantamine	Actavis Pharma, Inc.	ANDA	Current
0591-3498	Galantamine	Galantamine	Actavis Pharma, Inc.	ANDA	Current
0591-3498	Galantamine	Galantamine	Actavis Pharma, Inc.	ANDA	Current
0591-3498	Galantamine	Galantamine	Actavis Pharma, Inc.	ANDA	Current
0591-3498	Galantamine	Galantamine	Actavis Pharma, Inc.	ANDA	Current
43353-984	Galantamine hydrobromide	Galantamine hydrobromide	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current