Application 204895

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	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 42.

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
A204895-001	GALANTAMINE HYDROBROMIDE	GALANTAMINE HYDROBROMIDE	EQ 8MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2016-08-05
A204895-002	GALANTAMINE HYDROBROMIDE	GALANTAMINE HYDROBROMIDE	EQ 16MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB		2016-08-05
A204895-003	GALANTAMINE HYDROBROMIDE	GALANTAMINE HYDROBROMIDE	EQ 24MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB		2016-08-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A204895-001	AB
A204895-002	AB
A204895-003	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 · 126 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
2026-08-18 06:07:40	2026-07	A204895-001	GALANTAMINE HYDROBROMIDE	EQ 8MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2016-08-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204895-002	GALANTAMINE HYDROBROMIDE	EQ 16MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB		2016-08-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204895-003	GALANTAMINE HYDROBROMIDE	EQ 24MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB		2016-08-05	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204895-001	GALANTAMINE HYDROBROMIDE	EQ 8MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2016-08-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204895-002	GALANTAMINE HYDROBROMIDE	EQ 16MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB		2016-08-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204895-003	GALANTAMINE HYDROBROMIDE	EQ 24MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB		2016-08-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204895-001	GALANTAMINE HYDROBROMIDE	EQ 8MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2016-08-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204895-002	GALANTAMINE HYDROBROMIDE	EQ 16MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB		2016-08-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204895-003	GALANTAMINE HYDROBROMIDE	EQ 24MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB		2016-08-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204895-001	GALANTAMINE HYDROBROMIDE	EQ 8MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2016-08-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204895-002	GALANTAMINE HYDROBROMIDE	EQ 16MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB		2016-08-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204895-003	GALANTAMINE HYDROBROMIDE	EQ 24MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB		2016-08-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204895-001	GALANTAMINE HYDROBROMIDE	EQ 8MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2016-08-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204895-002	GALANTAMINE HYDROBROMIDE	EQ 16MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB		2016-08-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204895-003	GALANTAMINE HYDROBROMIDE	EQ 24MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB		2016-08-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204895-001	GALANTAMINE HYDROBROMIDE	EQ 8MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2016-08-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204895-002	GALANTAMINE HYDROBROMIDE	EQ 16MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB		2016-08-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204895-003	GALANTAMINE HYDROBROMIDE	EQ 24MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB		2016-08-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204895-001	GALANTAMINE HYDROBROMIDE	EQ 8MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2016-08-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204895-002	GALANTAMINE HYDROBROMIDE	EQ 16MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB		2016-08-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204895-003	GALANTAMINE HYDROBROMIDE	EQ 24MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB		2016-08-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204895-001	GALANTAMINE HYDROBROMIDE	EQ 8MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2016-08-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204895-002	GALANTAMINE HYDROBROMIDE	EQ 16MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB		2016-08-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204895-003	GALANTAMINE HYDROBROMIDE	EQ 24MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB		2016-08-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204895-001	GALANTAMINE HYDROBROMIDE	EQ 8MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2016-08-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204895-002	GALANTAMINE HYDROBROMIDE	EQ 16MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB		2016-08-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204895-003	GALANTAMINE HYDROBROMIDE	EQ 24MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB		2016-08-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204895-001	GALANTAMINE HYDROBROMIDE	EQ 8MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2016-08-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204895-002	GALANTAMINE HYDROBROMIDE	EQ 16MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB		2016-08-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204895-003	GALANTAMINE HYDROBROMIDE	EQ 24MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB		2016-08-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204895-001	GALANTAMINE HYDROBROMIDE	EQ 8MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2016-08-05	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204895-002	GALANTAMINE HYDROBROMIDE	EQ 16MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB		2016-08-05	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204895-003	GALANTAMINE HYDROBROMIDE	EQ 24MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB		2016-08-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204895-001	GALANTAMINE HYDROBROMIDE	EQ 8MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2016-08-05	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204895-002	GALANTAMINE HYDROBROMIDE	EQ 16MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB		2016-08-05	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204895-003	GALANTAMINE HYDROBROMIDE	EQ 24MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB		2016-08-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204895-001	GALANTAMINE HYDROBROMIDE	EQ 8MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2016-08-05	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204895-002	GALANTAMINE HYDROBROMIDE	EQ 16MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB		2016-08-05	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204895-003	GALANTAMINE HYDROBROMIDE	EQ 24MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB		2016-08-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204895-001	GALANTAMINE HYDROBROMIDE	EQ 8MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2016-08-05	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A204895-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204895-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204895-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204895-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204895-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204895-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204895-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204895-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204895-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204895-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204895-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204895-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204895-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204895-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204895-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204895-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204895-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204895-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204895-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204895-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204895-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204895-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204895-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204895-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204895-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204895-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204895-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204895-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204895-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204895-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204895-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204895-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204895-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204895-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204895-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204895-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204895-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204895-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204895-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204895-001	AB	1	`1e350fbaab3a…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Galantamine	GALANTAMINE	Aurobindo Pharma Limited	d0b75970-8d3d-408b-9e17-9cbad0f776b1	2024-01-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204895 application number: ANDA204895 ndc (product): 65862-744 ndc (product): 65862-745 ndc (product): 65862-746

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 21 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
65862-744	Galantamine	Galantamine	Aurobindo Pharma Limited	ANDA	Current
65862-744	Galantamine	Galantamine	Aurobindo Pharma Limited	ANDA	Current
65862-744	Galantamine	Galantamine	Aurobindo Pharma Limited	ANDA	Current
65862-744	Galantamine	Galantamine	Aurobindo Pharma Limited	ANDA	Current
65862-744	Galantamine	Galantamine	Aurobindo Pharma Limited	ANDA	Current
65862-744	Galantamine	Galantamine	Aurobindo Pharma Limited	ANDA	Current
65862-744	Galantamine	Galantamine	Aurobindo Pharma Limited	ANDA	Current
65862-745	Galantamine	Galantamine	Aurobindo Pharma Limited	ANDA	Current
65862-745	Galantamine	Galantamine	Aurobindo Pharma Limited	ANDA	Current
65862-745	Galantamine	Galantamine	Aurobindo Pharma Limited	ANDA	Current
65862-745	Galantamine	Galantamine	Aurobindo Pharma Limited	ANDA	Current
65862-745	Galantamine	Galantamine	Aurobindo Pharma Limited	ANDA	Current
65862-745	Galantamine	Galantamine	Aurobindo Pharma Limited	ANDA	Current
65862-745	Galantamine	Galantamine	Aurobindo Pharma Limited	ANDA	Current
65862-746	Galantamine	Galantamine	Aurobindo Pharma Limited	ANDA	Current
65862-746	Galantamine	Galantamine	Aurobindo Pharma Limited	ANDA	Current
65862-746	Galantamine	Galantamine	Aurobindo Pharma Limited	ANDA	Current
65862-746	Galantamine	Galantamine	Aurobindo Pharma Limited	ANDA	Current
65862-746	Galantamine	Galantamine	Aurobindo Pharma Limited	ANDA	Current
65862-746	Galantamine	Galantamine	Aurobindo Pharma Limited	ANDA	Current
65862-746	Galantamine	Galantamine	Aurobindo Pharma Limited	ANDA	Current