Application 091689

Type: ANDA
Sponsor: ALEMBIC PHARMS 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
A091689-001	RIVASTIGMINE TARTRATE	RIVASTIGMINE TARTRATE	EQ 1.5MG BASE	CAPSULE / ORAL	AB	2012-06-12
A091689-002	RIVASTIGMINE TARTRATE	RIVASTIGMINE TARTRATE	EQ 3MG BASE	CAPSULE / ORAL	AB	2012-06-12
A091689-003	RIVASTIGMINE TARTRATE	RIVASTIGMINE TARTRATE	EQ 4.5MG BASE	CAPSULE / ORAL	AB	2012-06-12
A091689-004	RIVASTIGMINE TARTRATE	RIVASTIGMINE TARTRATE	EQ 6MG BASE	CAPSULE / ORAL	AB	2012-06-12

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A091689-001	AB
A091689-002	AB
A091689-003	AB
A091689-004	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	A091689-001	RIVASTIGMINE TARTRATE	EQ 1.5MG BASE	CAPSULE / ORAL	AB	2012-06-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091689-002	RIVASTIGMINE TARTRATE	EQ 3MG BASE	CAPSULE / ORAL	AB	2012-06-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091689-003	RIVASTIGMINE TARTRATE	EQ 4.5MG BASE	CAPSULE / ORAL	AB	2012-06-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091689-004	RIVASTIGMINE TARTRATE	EQ 6MG BASE	CAPSULE / ORAL	AB	2012-06-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091689-001	RIVASTIGMINE TARTRATE	EQ 1.5MG BASE	CAPSULE / ORAL	AB	2012-06-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091689-002	RIVASTIGMINE TARTRATE	EQ 3MG BASE	CAPSULE / ORAL	AB	2012-06-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091689-003	RIVASTIGMINE TARTRATE	EQ 4.5MG BASE	CAPSULE / ORAL	AB	2012-06-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091689-004	RIVASTIGMINE TARTRATE	EQ 6MG BASE	CAPSULE / ORAL	AB	2012-06-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091689-001	RIVASTIGMINE TARTRATE	EQ 1.5MG BASE	CAPSULE / ORAL	AB	2012-06-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091689-002	RIVASTIGMINE TARTRATE	EQ 3MG BASE	CAPSULE / ORAL	AB	2012-06-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091689-003	RIVASTIGMINE TARTRATE	EQ 4.5MG BASE	CAPSULE / ORAL	AB	2012-06-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091689-004	RIVASTIGMINE TARTRATE	EQ 6MG BASE	CAPSULE / ORAL	AB	2012-06-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091689-001	RIVASTIGMINE TARTRATE	EQ 1.5MG BASE	CAPSULE / ORAL	AB	2012-06-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091689-002	RIVASTIGMINE TARTRATE	EQ 3MG BASE	CAPSULE / ORAL	AB	2012-06-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091689-003	RIVASTIGMINE TARTRATE	EQ 4.5MG BASE	CAPSULE / ORAL	AB	2012-06-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091689-004	RIVASTIGMINE TARTRATE	EQ 6MG BASE	CAPSULE / ORAL	AB	2012-06-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091689-001	RIVASTIGMINE TARTRATE	EQ 1.5MG BASE	CAPSULE / ORAL	AB	2012-06-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091689-002	RIVASTIGMINE TARTRATE	EQ 3MG BASE	CAPSULE / ORAL	AB	2012-06-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091689-003	RIVASTIGMINE TARTRATE	EQ 4.5MG BASE	CAPSULE / ORAL	AB	2012-06-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091689-004	RIVASTIGMINE TARTRATE	EQ 6MG BASE	CAPSULE / ORAL	AB	2012-06-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091689-001	RIVASTIGMINE TARTRATE	EQ 1.5MG BASE	CAPSULE / ORAL	AB	2012-06-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091689-002	RIVASTIGMINE TARTRATE	EQ 3MG BASE	CAPSULE / ORAL	AB	2012-06-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091689-003	RIVASTIGMINE TARTRATE	EQ 4.5MG BASE	CAPSULE / ORAL	AB	2012-06-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091689-004	RIVASTIGMINE TARTRATE	EQ 6MG BASE	CAPSULE / ORAL	AB	2012-06-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091689-001	RIVASTIGMINE TARTRATE	EQ 1.5MG BASE	CAPSULE / ORAL	AB	2012-06-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091689-002	RIVASTIGMINE TARTRATE	EQ 3MG BASE	CAPSULE / ORAL	AB	2012-06-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091689-003	RIVASTIGMINE TARTRATE	EQ 4.5MG BASE	CAPSULE / ORAL	AB	2012-06-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091689-004	RIVASTIGMINE TARTRATE	EQ 6MG BASE	CAPSULE / ORAL	AB	2012-06-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091689-001	RIVASTIGMINE TARTRATE	EQ 1.5MG BASE	CAPSULE / ORAL	AB	2012-06-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091689-002	RIVASTIGMINE TARTRATE	EQ 3MG BASE	CAPSULE / ORAL	AB	2012-06-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091689-003	RIVASTIGMINE TARTRATE	EQ 4.5MG BASE	CAPSULE / ORAL	AB	2012-06-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091689-004	RIVASTIGMINE TARTRATE	EQ 6MG BASE	CAPSULE / ORAL	AB	2012-06-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091689-001	RIVASTIGMINE TARTRATE	EQ 1.5MG BASE	CAPSULE / ORAL	AB	2012-06-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091689-002	RIVASTIGMINE TARTRATE	EQ 3MG BASE	CAPSULE / ORAL	AB	2012-06-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091689-003	RIVASTIGMINE TARTRATE	EQ 4.5MG BASE	CAPSULE / ORAL	AB	2012-06-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091689-004	RIVASTIGMINE TARTRATE	EQ 6MG BASE	CAPSULE / ORAL	AB	2012-06-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091689-001	RIVASTIGMINE TARTRATE	EQ 1.5MG BASE	CAPSULE / ORAL	AB	2012-06-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091689-002	RIVASTIGMINE TARTRATE	EQ 3MG BASE	CAPSULE / ORAL	AB	2012-06-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091689-003	RIVASTIGMINE TARTRATE	EQ 4.5MG BASE	CAPSULE / ORAL	AB	2012-06-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091689-004	RIVASTIGMINE TARTRATE	EQ 6MG BASE	CAPSULE / ORAL	AB	2012-06-12	`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	A091689-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091689-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091689-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091689-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091689-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091689-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091689-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091689-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091689-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091689-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091689-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091689-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091689-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091689-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091689-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091689-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091689-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091689-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091689-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091689-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091689-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091689-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091689-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091689-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091689-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091689-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091689-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091689-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091689-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091689-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091689-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091689-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091689-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091689-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091689-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091689-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091689-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091689-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091689-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091689-004	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	Alembic Pharmaceuticals Limited	33e6a772-382d-45f5-9d45-966c07759367	2023-01-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091689 application number: ANDA091689 ndc (product): 46708-065 ndc (product): 46708-066 ndc (product): 46708-063 ndc (product): 46708-064
Rivastigmine Tartrate	RIVASTIGMINE TARTRATE	Alembic Pharmaceuticals Inc.	0044f1d7-613c-4611-8481-13032c8cb390	2022-03-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091689 application number: ANDA091689 ndc (product): 62332-066 ndc (product): 62332-064 ndc (product): 62332-065 ndc (product): 62332-063

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 31 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
46708-063	Rivastigmine Tartrate	Rivastigmine Tartrate	Alembic Pharmaceuticals Limited	ANDA	Current
46708-063	Rivastigmine Tartrate	Rivastigmine Tartrate	Alembic Pharmaceuticals Limited	ANDA	Current
46708-064	Rivastigmine Tartrate	Rivastigmine Tartrate	Alembic Pharmaceuticals Limited	ANDA	Current
46708-064	Rivastigmine Tartrate	Rivastigmine Tartrate	Alembic Pharmaceuticals Limited	ANDA	Current
46708-065	Rivastigmine Tartrate	Rivastigmine Tartrate	Alembic Pharmaceuticals Limited	ANDA	Current
46708-065	Rivastigmine Tartrate	Rivastigmine Tartrate	Alembic Pharmaceuticals Limited	ANDA	Current
46708-066	Rivastigmine Tartrate	Rivastigmine Tartrate	Alembic Pharmaceuticals Limited	ANDA	Current
46708-066	Rivastigmine Tartrate	Rivastigmine Tartrate	Alembic Pharmaceuticals Limited	ANDA	Current
51991-793	Rivastigmine Tartrate	Rivastigmine Tartrate	Breckenridge Pharmaceutical, Inc	ANDA	Current
51991-793	Rivastigmine Tartrate	Rivastigmine Tartrate	Breckenridge Pharmaceutical, Inc	ANDA	Current
51991-793	Rivastigmine Tartrate	Rivastigmine Tartrate	Breckenridge Pharmaceutical, Inc	ANDA	Current
51991-793	Rivastigmine Tartrate	Rivastigmine Tartrate	Breckenridge Pharmaceutical, Inc	ANDA	Current
51991-794	Rivastigmine Tartrate	Rivastigmine Tartrate	Breckenridge Pharmaceutical, Inc	ANDA	Current
51991-794	Rivastigmine Tartrate	Rivastigmine Tartrate	Breckenridge Pharmaceutical, Inc	ANDA	Current
51991-794	Rivastigmine Tartrate	Rivastigmine Tartrate	Breckenridge Pharmaceutical, Inc	ANDA	Current
51991-794	Rivastigmine Tartrate	Rivastigmine Tartrate	Breckenridge Pharmaceutical, Inc	ANDA	Current
51991-795	Rivastigmine Tartrate	Rivastigmine Tartrate	Breckenridge Pharmaceutical, Inc	ANDA	Current
51991-795	Rivastigmine Tartrate	Rivastigmine Tartrate	Breckenridge Pharmaceutical, Inc	ANDA	Current
51991-795	Rivastigmine Tartrate	Rivastigmine Tartrate	Breckenridge Pharmaceutical, Inc	ANDA	Current
51991-795	Rivastigmine Tartrate	Rivastigmine Tartrate	Breckenridge Pharmaceutical, Inc	ANDA	Current
51991-796	Rivastigmine Tartrate	Rivastigmine Tartrate	Breckenridge Pharmaceutical, Inc	ANDA	Current
51991-796	Rivastigmine Tartrate	Rivastigmine Tartrate	Breckenridge Pharmaceutical, Inc	ANDA	Current
51991-796	Rivastigmine Tartrate	Rivastigmine Tartrate	Breckenridge Pharmaceutical, Inc	ANDA	Current
51991-796	Rivastigmine Tartrate	Rivastigmine Tartrate	Breckenridge Pharmaceutical, Inc	ANDA	Current
60687-574	Rivastigmine Tartrate	Rivastigmine Tartrate	American Health Packaging	ANDA	Current
60687-574	Rivastigmine Tartrate	Rivastigmine Tartrate	American Health Packaging	ANDA	Current
60687-574	Rivastigmine Tartrate	Rivastigmine Tartrate	American Health Packaging	ANDA	Current
62332-063	Rivastigmine Tartrate	Rivastigmine Tartrate	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-064	Rivastigmine Tartrate	Rivastigmine Tartrate	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-065	Rivastigmine Tartrate	Rivastigmine Tartrate	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-066	Rivastigmine Tartrate	Rivastigmine Tartrate	Alembic Pharmaceuticals Inc.	ANDA	Current