Application 091072

Type: ANDA
Sponsor: APOTEX INC

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	Approval date
A091072-001	RIVASTIGMINE TARTRATE	RIVASTIGMINE TARTRATE	EQ 1.5MG BASE	CAPSULE / ORAL	2013-05-16
A091072-002	RIVASTIGMINE TARTRATE	RIVASTIGMINE TARTRATE	EQ 3MG BASE	CAPSULE / ORAL	2013-05-16
A091072-003	RIVASTIGMINE TARTRATE	RIVASTIGMINE TARTRATE	EQ 4.5MG BASE	CAPSULE / ORAL	2013-05-16
A091072-004	RIVASTIGMINE TARTRATE	RIVASTIGMINE TARTRATE	EQ 6MG BASE	CAPSULE / ORAL	2013-05-16

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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A091072-001	RIVASTIGMINE TARTRATE	EQ 1.5MG BASE	CAPSULE / ORAL	2013-05-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091072-002	RIVASTIGMINE TARTRATE	EQ 3MG BASE	CAPSULE / ORAL	2013-05-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091072-003	RIVASTIGMINE TARTRATE	EQ 4.5MG BASE	CAPSULE / ORAL	2013-05-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091072-004	RIVASTIGMINE TARTRATE	EQ 6MG BASE	CAPSULE / ORAL	2013-05-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091072-001	RIVASTIGMINE TARTRATE	EQ 1.5MG BASE	CAPSULE / ORAL	2013-05-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091072-002	RIVASTIGMINE TARTRATE	EQ 3MG BASE	CAPSULE / ORAL	2013-05-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091072-003	RIVASTIGMINE TARTRATE	EQ 4.5MG BASE	CAPSULE / ORAL	2013-05-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091072-004	RIVASTIGMINE TARTRATE	EQ 6MG BASE	CAPSULE / ORAL	2013-05-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091072-001	RIVASTIGMINE TARTRATE	EQ 1.5MG BASE	CAPSULE / ORAL	2013-05-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091072-002	RIVASTIGMINE TARTRATE	EQ 3MG BASE	CAPSULE / ORAL	2013-05-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091072-003	RIVASTIGMINE TARTRATE	EQ 4.5MG BASE	CAPSULE / ORAL	2013-05-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091072-004	RIVASTIGMINE TARTRATE	EQ 6MG BASE	CAPSULE / ORAL	2013-05-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091072-001	RIVASTIGMINE TARTRATE	EQ 1.5MG BASE	CAPSULE / ORAL	2013-05-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091072-002	RIVASTIGMINE TARTRATE	EQ 3MG BASE	CAPSULE / ORAL	2013-05-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091072-003	RIVASTIGMINE TARTRATE	EQ 4.5MG BASE	CAPSULE / ORAL	2013-05-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091072-004	RIVASTIGMINE TARTRATE	EQ 6MG BASE	CAPSULE / ORAL	2013-05-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091072-001	RIVASTIGMINE TARTRATE	EQ 1.5MG BASE	CAPSULE / ORAL	2013-05-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091072-002	RIVASTIGMINE TARTRATE	EQ 3MG BASE	CAPSULE / ORAL	2013-05-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091072-003	RIVASTIGMINE TARTRATE	EQ 4.5MG BASE	CAPSULE / ORAL	2013-05-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091072-004	RIVASTIGMINE TARTRATE	EQ 6MG BASE	CAPSULE / ORAL	2013-05-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091072-001	RIVASTIGMINE TARTRATE	EQ 1.5MG BASE	CAPSULE / ORAL	2013-05-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091072-002	RIVASTIGMINE TARTRATE	EQ 3MG BASE	CAPSULE / ORAL	2013-05-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091072-003	RIVASTIGMINE TARTRATE	EQ 4.5MG BASE	CAPSULE / ORAL	2013-05-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091072-004	RIVASTIGMINE TARTRATE	EQ 6MG BASE	CAPSULE / ORAL	2013-05-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091072-001	RIVASTIGMINE TARTRATE	EQ 1.5MG BASE	CAPSULE / ORAL	2013-05-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091072-002	RIVASTIGMINE TARTRATE	EQ 3MG BASE	CAPSULE / ORAL	2013-05-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091072-003	RIVASTIGMINE TARTRATE	EQ 4.5MG BASE	CAPSULE / ORAL	2013-05-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091072-004	RIVASTIGMINE TARTRATE	EQ 6MG BASE	CAPSULE / ORAL	2013-05-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091072-001	RIVASTIGMINE TARTRATE	EQ 1.5MG BASE	CAPSULE / ORAL	2013-05-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091072-002	RIVASTIGMINE TARTRATE	EQ 3MG BASE	CAPSULE / ORAL	2013-05-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091072-003	RIVASTIGMINE TARTRATE	EQ 4.5MG BASE	CAPSULE / ORAL	2013-05-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091072-004	RIVASTIGMINE TARTRATE	EQ 6MG BASE	CAPSULE / ORAL	2013-05-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091072-001	RIVASTIGMINE TARTRATE	EQ 1.5MG BASE	CAPSULE / ORAL	2013-05-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091072-002	RIVASTIGMINE TARTRATE	EQ 3MG BASE	CAPSULE / ORAL	2013-05-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091072-003	RIVASTIGMINE TARTRATE	EQ 4.5MG BASE	CAPSULE / ORAL	2013-05-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091072-004	RIVASTIGMINE TARTRATE	EQ 6MG BASE	CAPSULE / ORAL	2013-05-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091072-001	RIVASTIGMINE TARTRATE	EQ 1.5MG BASE	CAPSULE / ORAL	2013-05-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091072-002	RIVASTIGMINE TARTRATE	EQ 3MG BASE	CAPSULE / ORAL	2013-05-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091072-003	RIVASTIGMINE TARTRATE	EQ 4.5MG BASE	CAPSULE / ORAL	2013-05-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091072-004	RIVASTIGMINE TARTRATE	EQ 6MG BASE	CAPSULE / ORAL	2013-05-16	`d06236e962d9…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A091072-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A091072-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A091072-003	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A091072-004	AB	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A091072-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A091072-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A091072-003	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A091072-004	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091072-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A091072-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A091072-003	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A091072-004	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091072-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A091072-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A091072-003	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A091072-004	AB	1	`ea99ee380514…`

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 · 12 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Rivastigmine Tartrate	RIVASTIGMINE TARTRATE	American Health Packaging	52781229-ee82-43f9-a113-4419a611978d	2025-11-11	Warnings, Adverse reactions	Name fallback brand name: Rivastigmine Tartrate generic name: RIVASTIGMINE TARTRATE
Rivastigmine Tartrate	RIVASTIGMINE TARTRATE	Major Pharmaceuticals	39aadc39-0f4f-44f7-88de-83a0ea2ac332	2025-03-03	Warnings, Adverse reactions	Name fallback brand name: Rivastigmine Tartrate generic name: RIVASTIGMINE TARTRATE
Rivastigmine Tartrate	RIVASTIGMINE TARTRATE	Aurobindo Pharma Limited	c246a0e5-1e77-41ee-a7b3-384f21f2f2e0	2024-06-19	Warnings, Adverse reactions	Name fallback brand name: Rivastigmine Tartrate generic name: RIVASTIGMINE TARTRATE
Rivastigmine Tartrate	RIVASTIGMINE TARTRATE	Chartwell RX, LLC	2bb5e0d6-f677-4021-9888-3ff90979ef7d	2023-10-06	Warnings, Adverse reactions	Name fallback brand name: Rivastigmine Tartrate generic name: RIVASTIGMINE TARTRATE
Rivastigmine Tartrate	RIVASTIGMINE TARTRATE	Alembic Pharmaceuticals Limited	33e6a772-382d-45f5-9d45-966c07759367	2023-01-16	Warnings, Adverse reactions	Name fallback brand name: Rivastigmine Tartrate generic name: RIVASTIGMINE TARTRATE
Rivastigmine Tartrate	RIVASTIGMINE TARTRATE	Cadila Pharmaceuticals Limited	e7e641fe-39bd-4681-a430-6dedeb6d6af5	2022-12-29	Warnings, Adverse reactions	Name fallback brand name: Rivastigmine Tartrate generic name: RIVASTIGMINE TARTRATE
Rivastigmine Tartrate	RIVASTIGMINE TARTRATE	Modavar Pharmaceuticals LLC	209f3b02-0acf-46e9-b355-91c918a20eb3	2022-12-28	Warnings, Adverse reactions	Name fallback brand name: Rivastigmine Tartrate generic name: RIVASTIGMINE TARTRATE
RIVASTIGMINE TARTRATE	RIVASTIGMINE TARTRATE	Macleods Pharmaceuticals Limited	4364f6ef-a8da-4805-be0d-aabbe8ca2d21	2022-08-24	Warnings, Adverse reactions	Name fallback brand name: RIVASTIGMINE TARTRATE generic name: RIVASTIGMINE TARTRATE
Rivastigmine Tartrate	RIVASTIGMINE TARTRATE	Alembic Pharmaceuticals Inc.	0044f1d7-613c-4611-8481-13032c8cb390	2022-03-21	Warnings, Adverse reactions	Name fallback brand name: Rivastigmine Tartrate generic name: RIVASTIGMINE TARTRATE
RIVASTIGMINE TARTRATE	RIVASTIGMINE TARTRATE	Nivagen Pharmaceuticals, Inc.	83bd2ff6-1d8b-4cac-a37b-fd01dc3f34a1	2022-02-16	Warnings, Adverse reactions	Name fallback brand name: RIVASTIGMINE TARTRATE generic name: RIVASTIGMINE TARTRATE
Rivastigmine Tartrate	RIVASTIGMINE TARTRATE	Sun Pharmaceutical Industries, Inc.	bac9ca81-db70-41aa-82af-6c5bb8496846	2019-01-31	Warnings, Adverse reactions	Name fallback brand name: Rivastigmine Tartrate generic name: RIVASTIGMINE TARTRATE
Rivastigmine Tartrate	RIVASTIGMINE TARTRATE	Dr. Reddy's Laboratories Limited	0e20124c-725a-0145-996c-2ff908703162	2019-01-23	Warnings, Adverse reactions	Name fallback brand name: Rivastigmine Tartrate generic name: RIVASTIGMINE TARTRATE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
60429-393	Rivastigmine Tartrate	Rivastigmine Tartrate	Golden State Medical Supply, Inc.	ANDA	Current
60429-394	Rivastigmine Tartrate	Rivastigmine Tartrate	Golden State Medical Supply, Inc.	ANDA	Current
60429-395	Rivastigmine Tartrate	Rivastigmine Tartrate	Golden State Medical Supply, Inc.	ANDA	Current
60429-396	Rivastigmine Tartrate	Rivastigmine Tartrate	Golden State Medical Supply, Inc.	ANDA	Current
60505-3220	Rivastigmine Tartrate	Rivastigmine Tartrate	Apotex Corp.	ANDA	Current
60505-3221	Rivastigmine Tartrate	Rivastigmine Tartrate	Apotex Corp.	ANDA	Current
60505-3222	Rivastigmine Tartrate	Rivastigmine Tartrate	Apotex Corp.	ANDA	Current
60505-3223	Rivastigmine Tartrate	Rivastigmine Tartrate	Apotex Corp.	ANDA	Current