Application 204572

Type: ANDA
Sponsor: AUROBINDO PHARMA LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	RIVASTIGMINE TARTRATE	RIVASTIGMINE TARTRATE	CAPSULE;ORAL	EQ 1.5MG BASE	No	No
002	RIVASTIGMINE TARTRATE	RIVASTIGMINE TARTRATE	CAPSULE;ORAL	EQ 3MG BASE	No	No
003	RIVASTIGMINE TARTRATE	RIVASTIGMINE TARTRATE	CAPSULE;ORAL	EQ 4.5MG BASE	No	No
004	RIVASTIGMINE TARTRATE	RIVASTIGMINE TARTRATE	CAPSULE;ORAL	EQ 6MG 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 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A204572-001	RIVASTIGMINE TARTRATE	RIVASTIGMINE TARTRATE	EQ 1.5MG BASE	CAPSULE / ORAL	AB	2016-03-25
A204572-002	RIVASTIGMINE TARTRATE	RIVASTIGMINE TARTRATE	EQ 3MG BASE	CAPSULE / ORAL	AB	2016-03-25
A204572-003	RIVASTIGMINE TARTRATE	RIVASTIGMINE TARTRATE	EQ 4.5MG BASE	CAPSULE / ORAL	AB	2016-03-25
A204572-004	RIVASTIGMINE TARTRATE	RIVASTIGMINE TARTRATE	EQ 6MG BASE	CAPSULE / ORAL	AB	2016-03-25

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
A204572-001	AB
A204572-002	AB
A204572-003	AB
A204572-004	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 5 · 164 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	A204572-001	RIVASTIGMINE TARTRATE	EQ 1.5MG BASE	CAPSULE / ORAL	AB	2016-03-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204572-002	RIVASTIGMINE TARTRATE	EQ 3MG BASE	CAPSULE / ORAL	AB	2016-03-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204572-003	RIVASTIGMINE TARTRATE	EQ 4.5MG BASE	CAPSULE / ORAL	AB	2016-03-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204572-004	RIVASTIGMINE TARTRATE	EQ 6MG BASE	CAPSULE / ORAL	AB	2016-03-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204572-001	RIVASTIGMINE TARTRATE	EQ 1.5MG BASE	CAPSULE / ORAL	AB	2016-03-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204572-002	RIVASTIGMINE TARTRATE	EQ 3MG BASE	CAPSULE / ORAL	AB	2016-03-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204572-003	RIVASTIGMINE TARTRATE	EQ 4.5MG BASE	CAPSULE / ORAL	AB	2016-03-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204572-004	RIVASTIGMINE TARTRATE	EQ 6MG BASE	CAPSULE / ORAL	AB	2016-03-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204572-001	RIVASTIGMINE TARTRATE	EQ 1.5MG BASE	CAPSULE / ORAL	AB	2016-03-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204572-002	RIVASTIGMINE TARTRATE	EQ 3MG BASE	CAPSULE / ORAL	AB	2016-03-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204572-003	RIVASTIGMINE TARTRATE	EQ 4.5MG BASE	CAPSULE / ORAL	AB	2016-03-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204572-004	RIVASTIGMINE TARTRATE	EQ 6MG BASE	CAPSULE / ORAL	AB	2016-03-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204572-001	RIVASTIGMINE TARTRATE	EQ 1.5MG BASE	CAPSULE / ORAL	AB	2016-03-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204572-002	RIVASTIGMINE TARTRATE	EQ 3MG BASE	CAPSULE / ORAL	AB	2016-03-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204572-003	RIVASTIGMINE TARTRATE	EQ 4.5MG BASE	CAPSULE / ORAL	AB	2016-03-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204572-004	RIVASTIGMINE TARTRATE	EQ 6MG BASE	CAPSULE / ORAL	AB	2016-03-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204572-001	RIVASTIGMINE TARTRATE	EQ 1.5MG BASE	CAPSULE / ORAL	AB	2016-03-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204572-002	RIVASTIGMINE TARTRATE	EQ 3MG BASE	CAPSULE / ORAL	AB	2016-03-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204572-003	RIVASTIGMINE TARTRATE	EQ 4.5MG BASE	CAPSULE / ORAL	AB	2016-03-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204572-004	RIVASTIGMINE TARTRATE	EQ 6MG BASE	CAPSULE / ORAL	AB	2016-03-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204572-001	RIVASTIGMINE TARTRATE	EQ 1.5MG BASE	CAPSULE / ORAL	AB	2016-03-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204572-002	RIVASTIGMINE TARTRATE	EQ 3MG BASE	CAPSULE / ORAL	AB	2016-03-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204572-003	RIVASTIGMINE TARTRATE	EQ 4.5MG BASE	CAPSULE / ORAL	AB	2016-03-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204572-004	RIVASTIGMINE TARTRATE	EQ 6MG BASE	CAPSULE / ORAL	AB	2016-03-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204572-001	RIVASTIGMINE TARTRATE	EQ 1.5MG BASE	CAPSULE / ORAL	AB	2016-03-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204572-002	RIVASTIGMINE TARTRATE	EQ 3MG BASE	CAPSULE / ORAL	AB	2016-03-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204572-003	RIVASTIGMINE TARTRATE	EQ 4.5MG BASE	CAPSULE / ORAL	AB	2016-03-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204572-004	RIVASTIGMINE TARTRATE	EQ 6MG BASE	CAPSULE / ORAL	AB	2016-03-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204572-001	RIVASTIGMINE TARTRATE	EQ 1.5MG BASE	CAPSULE / ORAL	AB	2016-03-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204572-002	RIVASTIGMINE TARTRATE	EQ 3MG BASE	CAPSULE / ORAL	AB	2016-03-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204572-003	RIVASTIGMINE TARTRATE	EQ 4.5MG BASE	CAPSULE / ORAL	AB	2016-03-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204572-004	RIVASTIGMINE TARTRATE	EQ 6MG BASE	CAPSULE / ORAL	AB	2016-03-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204572-001	RIVASTIGMINE TARTRATE	EQ 1.5MG BASE	CAPSULE / ORAL	AB	2016-03-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204572-002	RIVASTIGMINE TARTRATE	EQ 3MG BASE	CAPSULE / ORAL	AB	2016-03-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204572-003	RIVASTIGMINE TARTRATE	EQ 4.5MG BASE	CAPSULE / ORAL	AB	2016-03-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204572-004	RIVASTIGMINE TARTRATE	EQ 6MG BASE	CAPSULE / ORAL	AB	2016-03-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204572-001	RIVASTIGMINE TARTRATE	EQ 1.5MG BASE	CAPSULE / ORAL	AB	2016-03-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204572-002	RIVASTIGMINE TARTRATE	EQ 3MG BASE	CAPSULE / ORAL	AB	2016-03-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204572-003	RIVASTIGMINE TARTRATE	EQ 4.5MG BASE	CAPSULE / ORAL	AB	2016-03-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204572-004	RIVASTIGMINE TARTRATE	EQ 6MG BASE	CAPSULE / ORAL	AB	2016-03-25	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 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	A204572-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204572-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204572-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204572-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204572-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204572-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204572-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204572-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204572-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204572-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204572-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204572-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204572-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204572-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204572-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204572-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204572-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204572-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204572-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204572-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204572-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204572-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204572-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204572-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204572-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204572-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204572-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204572-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204572-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204572-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204572-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204572-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204572-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204572-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204572-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204572-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204572-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204572-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204572-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204572-004	AB	1	`d06236e962d9…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Rivastigmine Tartrate	RIVASTIGMINE TARTRATE	Major Pharmaceuticals	39aadc39-0f4f-44f7-88de-83a0ea2ac332	2025-03-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204572 application number: ANDA204572 ndc (product): 0904-7107
Rivastigmine Tartrate	RIVASTIGMINE TARTRATE	Aurobindo Pharma Limited	c246a0e5-1e77-41ee-a7b3-384f21f2f2e0	2024-06-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204572 application number: ANDA204572 ndc (product): 65862-651 ndc (product): 65862-650 ndc (product): 65862-649 ndc (product): 65862-648

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 19 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0904-7107	Rivastigmine Tartrate	Rivastigmine Tartrate	Major Pharmaceuticals	ANDA	Current
0904-7107	Rivastigmine Tartrate	Rivastigmine Tartrate	Major Pharmaceuticals	ANDA	Current
65862-648	Rivastigmine Tartrate	Rivastigmine Tartrate	Aurobindo Pharma Limited	ANDA	Current
65862-648	Rivastigmine Tartrate	Rivastigmine Tartrate	Aurobindo Pharma Limited	ANDA	Current
65862-648	Rivastigmine Tartrate	Rivastigmine Tartrate	Aurobindo Pharma Limited	ANDA	Current
65862-648	Rivastigmine Tartrate	Rivastigmine Tartrate	Aurobindo Pharma Limited	ANDA	Current
65862-649	Rivastigmine Tartrate	Rivastigmine Tartrate	Aurobindo Pharma Limited	ANDA	Current
65862-649	Rivastigmine Tartrate	Rivastigmine Tartrate	Aurobindo Pharma Limited	ANDA	Current
65862-649	Rivastigmine Tartrate	Rivastigmine Tartrate	Aurobindo Pharma Limited	ANDA	Current
65862-649	Rivastigmine Tartrate	Rivastigmine Tartrate	Aurobindo Pharma Limited	ANDA	Current
65862-650	Rivastigmine Tartrate	Rivastigmine Tartrate	Aurobindo Pharma Limited	ANDA	Current
65862-650	Rivastigmine Tartrate	Rivastigmine Tartrate	Aurobindo Pharma Limited	ANDA	Current
65862-650	Rivastigmine Tartrate	Rivastigmine Tartrate	Aurobindo Pharma Limited	ANDA	Current
65862-650	Rivastigmine Tartrate	Rivastigmine Tartrate	Aurobindo Pharma Limited	ANDA	Current
65862-651	Rivastigmine Tartrate	Rivastigmine Tartrate	Aurobindo Pharma Limited	ANDA	Current
65862-651	Rivastigmine Tartrate	Rivastigmine Tartrate	Aurobindo Pharma Limited	ANDA	Current
65862-651	Rivastigmine Tartrate	Rivastigmine Tartrate	Aurobindo Pharma Limited	ANDA	Current
65862-651	Rivastigmine Tartrate	Rivastigmine Tartrate	Aurobindo Pharma Limited	ANDA	Current
70518-3012	Rivastigmine Tartrate	Rivastigmine Tartrate	REMEDYREPACK INC.	ANDA	Current