Application 090957

Type: ANDA
Sponsor: AUROBINDO PHARMA LTD

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	Approval date
A090957-001	GALANTAMINE HYDROBROMIDE	GALANTAMINE HYDROBROMIDE	EQ 4MG BASE	TABLET / ORAL	AB	2011-03-29
A090957-002	GALANTAMINE HYDROBROMIDE	GALANTAMINE HYDROBROMIDE	EQ 8MG BASE	TABLET / ORAL	AB	2011-03-29
A090957-003	GALANTAMINE HYDROBROMIDE	GALANTAMINE HYDROBROMIDE	EQ 12MG BASE	TABLET / ORAL	AB	2011-03-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A090957-001	AB
A090957-002	AB
A090957-003	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	A090957-001	GALANTAMINE HYDROBROMIDE	EQ 4MG BASE	TABLET / ORAL	AB	2011-03-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090957-002	GALANTAMINE HYDROBROMIDE	EQ 8MG BASE	TABLET / ORAL	AB	2011-03-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090957-003	GALANTAMINE HYDROBROMIDE	EQ 12MG BASE	TABLET / ORAL	AB	2011-03-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090957-001	GALANTAMINE HYDROBROMIDE	EQ 4MG BASE	TABLET / ORAL	AB	2011-03-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090957-002	GALANTAMINE HYDROBROMIDE	EQ 8MG BASE	TABLET / ORAL	AB	2011-03-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090957-003	GALANTAMINE HYDROBROMIDE	EQ 12MG BASE	TABLET / ORAL	AB	2011-03-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090957-001	GALANTAMINE HYDROBROMIDE	EQ 4MG BASE	TABLET / ORAL	AB	2011-03-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090957-002	GALANTAMINE HYDROBROMIDE	EQ 8MG BASE	TABLET / ORAL	AB	2011-03-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090957-003	GALANTAMINE HYDROBROMIDE	EQ 12MG BASE	TABLET / ORAL	AB	2011-03-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090957-001	GALANTAMINE HYDROBROMIDE	EQ 4MG BASE	TABLET / ORAL	AB	2011-03-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090957-002	GALANTAMINE HYDROBROMIDE	EQ 8MG BASE	TABLET / ORAL	AB	2011-03-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090957-003	GALANTAMINE HYDROBROMIDE	EQ 12MG BASE	TABLET / ORAL	AB	2011-03-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090957-001	GALANTAMINE HYDROBROMIDE	EQ 4MG BASE	TABLET / ORAL	AB	2011-03-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090957-002	GALANTAMINE HYDROBROMIDE	EQ 8MG BASE	TABLET / ORAL	AB	2011-03-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090957-003	GALANTAMINE HYDROBROMIDE	EQ 12MG BASE	TABLET / ORAL	AB	2011-03-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090957-001	GALANTAMINE HYDROBROMIDE	EQ 4MG BASE	TABLET / ORAL	AB	2011-03-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090957-002	GALANTAMINE HYDROBROMIDE	EQ 8MG BASE	TABLET / ORAL	AB	2011-03-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090957-003	GALANTAMINE HYDROBROMIDE	EQ 12MG BASE	TABLET / ORAL	AB	2011-03-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090957-001	GALANTAMINE HYDROBROMIDE	EQ 4MG BASE	TABLET / ORAL	AB	2011-03-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090957-002	GALANTAMINE HYDROBROMIDE	EQ 8MG BASE	TABLET / ORAL	AB	2011-03-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090957-003	GALANTAMINE HYDROBROMIDE	EQ 12MG BASE	TABLET / ORAL	AB	2011-03-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090957-001	GALANTAMINE HYDROBROMIDE	EQ 4MG BASE	TABLET / ORAL	AB	2011-03-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090957-002	GALANTAMINE HYDROBROMIDE	EQ 8MG BASE	TABLET / ORAL	AB	2011-03-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090957-003	GALANTAMINE HYDROBROMIDE	EQ 12MG BASE	TABLET / ORAL	AB	2011-03-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090957-001	GALANTAMINE HYDROBROMIDE	EQ 4MG BASE	TABLET / ORAL	AB	2011-03-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090957-002	GALANTAMINE HYDROBROMIDE	EQ 8MG BASE	TABLET / ORAL	AB	2011-03-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090957-003	GALANTAMINE HYDROBROMIDE	EQ 12MG BASE	TABLET / ORAL	AB	2011-03-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090957-001	GALANTAMINE HYDROBROMIDE	EQ 4MG BASE	TABLET / ORAL	AB	2011-03-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090957-002	GALANTAMINE HYDROBROMIDE	EQ 8MG BASE	TABLET / ORAL	AB	2011-03-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090957-003	GALANTAMINE HYDROBROMIDE	EQ 12MG BASE	TABLET / ORAL	AB	2011-03-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090957-001	GALANTAMINE HYDROBROMIDE	EQ 4MG BASE	TABLET / ORAL	AB	2011-03-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090957-002	GALANTAMINE HYDROBROMIDE	EQ 8MG BASE	TABLET / ORAL	AB	2011-03-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090957-003	GALANTAMINE HYDROBROMIDE	EQ 12MG BASE	TABLET / ORAL	AB	2011-03-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090957-001	GALANTAMINE HYDROBROMIDE	EQ 4MG BASE	TABLET / ORAL	AB	2011-03-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090957-002	GALANTAMINE HYDROBROMIDE	EQ 8MG BASE	TABLET / ORAL	AB	2011-03-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090957-003	GALANTAMINE HYDROBROMIDE	EQ 12MG BASE	TABLET / ORAL	AB	2011-03-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090957-001	GALANTAMINE HYDROBROMIDE	EQ 4MG BASE	TABLET / ORAL	AB	2011-03-29	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090957-002	GALANTAMINE HYDROBROMIDE	EQ 8MG BASE	TABLET / ORAL	AB	2011-03-29	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090957-003	GALANTAMINE HYDROBROMIDE	EQ 12MG BASE	TABLET / ORAL	AB	2011-03-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090957-001	GALANTAMINE HYDROBROMIDE	EQ 4MG BASE	TABLET / ORAL	AB	2011-03-29	`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	A090957-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090957-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090957-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090957-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090957-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090957-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090957-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090957-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090957-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090957-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090957-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090957-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090957-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090957-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090957-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090957-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090957-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090957-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090957-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090957-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090957-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090957-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090957-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090957-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090957-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090957-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090957-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090957-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090957-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090957-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090957-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090957-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090957-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090957-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090957-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090957-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090957-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090957-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090957-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090957-001	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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Galantamine	GALANTAMINE	Bryant Ranch Prepack	261889d3-41c8-4655-98f7-41317778e7a1	2026-07-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090957 application number: ANDA090957
Galantamine	GALANTAMINE	Bryant Ranch Prepack	694ea1a5-153a-4145-9910-a0a1dc4ddbcc	2025-11-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090957 application number: ANDA090957
Galantamine	GALANTAMINE	American Health Packaging	e80ec152-3616-4a13-9266-715550a8c398	2024-12-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090957 application number: ANDA090957 ndc (product): 68084-729
Galantamine	GALANTAMINE	Aurobindo Pharma Limited	4e05d1da-0eb8-4fe0-8259-f1ebb170e0dc	2024-02-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090957 application number: ANDA090957 ndc (product): 65862-459 ndc (product): 65862-458 ndc (product): 65862-460
Galantamine	GALANTAMINE	Rising Pharma Holdings, Inc.	a0dc1a93-b7b8-4179-8ea7-ceecbe1ef243	2024-02-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090957 application number: ANDA090957 ndc (product): 57237-050 ndc (product): 57237-051 ndc (product): 57237-049

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 36 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
57237-049	Galantamine	Galantamine	Rising Health, LLC	ANDA	Current
57237-049	Galantamine	Galantamine	Rising Health, LLC	ANDA	Current
57237-049	Galantamine	Galantamine	Rising Health, LLC	ANDA	Current
57237-049	Galantamine	Galantamine	Rising Health, LLC	ANDA	Current
57237-050	Galantamine	Galantamine	Rising Health, LLC	ANDA	Current
57237-050	Galantamine	Galantamine	Rising Health, LLC	ANDA	Current
57237-050	Galantamine	Galantamine	Rising Health, LLC	ANDA	Current
57237-050	Galantamine	Galantamine	Rising Health, LLC	ANDA	Current
57237-051	Galantamine	Galantamine	Rising Health, LLC	ANDA	Current
57237-051	Galantamine	Galantamine	Rising Health, LLC	ANDA	Current
57237-051	Galantamine	Galantamine	Rising Health, LLC	ANDA	Current
57237-051	Galantamine	Galantamine	Rising Health, LLC	ANDA	Current
63739-708	Galantamine	Galantamine	McKesson Corporation	ANDA	Current
63739-708	Galantamine	Galantamine	McKesson Corporation dba SKY Packaging	ANDA	Current
63739-999	Galantamine	Galantamine	McKesson Corporation dba SKY Packaging	ANDA	Current
63739-999	Galantamine	Galantamine	McKesson Corporation	ANDA	Current
63739-999	Galantamine	Galantamine	McKesson Corporation dba SKY Packaging	ANDA	Current
65862-458	Galantamine	Galantamine	Aurobindo Pharma Limited	ANDA	Current
65862-458	Galantamine	Galantamine	Aurobindo Pharma Limited	ANDA	Current
65862-458	Galantamine	Galantamine	Aurobindo Pharma Limited	ANDA	Current
65862-458	Galantamine	Galantamine	Aurobindo Pharma Limited	ANDA	Current
65862-458	Galantamine	Galantamine	Aurobindo Pharma Limited	ANDA	Current
65862-459	Galantamine	Galantamine	Aurobindo Pharma Limited	ANDA	Current
65862-459	Galantamine	Galantamine	Aurobindo Pharma Limited	ANDA	Current
65862-459	Galantamine	Galantamine	Aurobindo Pharma Limited	ANDA	Current
65862-459	Galantamine	Galantamine	Aurobindo Pharma Limited	ANDA	Current
65862-459	Galantamine	Galantamine	Aurobindo Pharma Limited	ANDA	Current
65862-460	Galantamine	Galantamine	Aurobindo Pharma Limited	ANDA	Current
65862-460	Galantamine	Galantamine	Aurobindo Pharma Limited	ANDA	Current
65862-460	Galantamine	Galantamine	Aurobindo Pharma Limited	ANDA	Current
65862-460	Galantamine	Galantamine	Aurobindo Pharma Limited	ANDA	Current
65862-460	Galantamine	Galantamine	Aurobindo Pharma Limited	ANDA	Current
68084-729	Galantamine	Galantamine	American Health Packaging	ANDA	Current
68084-729	Galantamine	Galantamine	American Health Packaging	ANDA	Current
68084-729	Galantamine	Galantamine	American Health Packaging	ANDA	Current
68084-729	Galantamine	Galantamine	American Health Packaging	ANDA	Current