Application 077131

Type: ANDA
Sponsor: SUN PHARM

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 43.

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
A077131-001	RIVASTIGMINE TARTRATE	RIVASTIGMINE TARTRATE	EQ 1.5MG BASE	CAPSULE / ORAL	2007-10-22
A077131-002	RIVASTIGMINE TARTRATE	RIVASTIGMINE TARTRATE	EQ 3MG BASE	CAPSULE / ORAL	2007-10-22
A077131-003	RIVASTIGMINE TARTRATE	RIVASTIGMINE TARTRATE	EQ 4.5MG BASE	CAPSULE / ORAL	2007-10-22
A077131-004	RIVASTIGMINE TARTRATE	RIVASTIGMINE TARTRATE	EQ 6MG BASE	CAPSULE / ORAL	2007-10-22

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 · 172 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
2026-09-14 22:38:34	2026-08	A077131-001	RIVASTIGMINE TARTRATE	EQ 1.5MG BASE	CAPSULE / ORAL		2007-10-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077131-002	RIVASTIGMINE TARTRATE	EQ 3MG BASE	CAPSULE / ORAL		2007-10-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077131-003	RIVASTIGMINE TARTRATE	EQ 4.5MG BASE	CAPSULE / ORAL		2007-10-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077131-004	RIVASTIGMINE TARTRATE	EQ 6MG BASE	CAPSULE / ORAL		2007-10-22	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077131-001	RIVASTIGMINE TARTRATE	EQ 1.5MG BASE	CAPSULE / ORAL		2007-10-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077131-002	RIVASTIGMINE TARTRATE	EQ 3MG BASE	CAPSULE / ORAL		2007-10-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077131-003	RIVASTIGMINE TARTRATE	EQ 4.5MG BASE	CAPSULE / ORAL		2007-10-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077131-004	RIVASTIGMINE TARTRATE	EQ 6MG BASE	CAPSULE / ORAL		2007-10-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077131-001	RIVASTIGMINE TARTRATE	EQ 1.5MG BASE	CAPSULE / ORAL		2007-10-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077131-002	RIVASTIGMINE TARTRATE	EQ 3MG BASE	CAPSULE / ORAL		2007-10-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077131-003	RIVASTIGMINE TARTRATE	EQ 4.5MG BASE	CAPSULE / ORAL		2007-10-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077131-004	RIVASTIGMINE TARTRATE	EQ 6MG BASE	CAPSULE / ORAL		2007-10-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077131-001	RIVASTIGMINE TARTRATE	EQ 1.5MG BASE	CAPSULE / ORAL		2007-10-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077131-002	RIVASTIGMINE TARTRATE	EQ 3MG BASE	CAPSULE / ORAL		2007-10-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077131-003	RIVASTIGMINE TARTRATE	EQ 4.5MG BASE	CAPSULE / ORAL		2007-10-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077131-004	RIVASTIGMINE TARTRATE	EQ 6MG BASE	CAPSULE / ORAL		2007-10-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077131-001	RIVASTIGMINE TARTRATE	EQ 1.5MG BASE	CAPSULE / ORAL		2007-10-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077131-002	RIVASTIGMINE TARTRATE	EQ 3MG BASE	CAPSULE / ORAL		2007-10-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077131-003	RIVASTIGMINE TARTRATE	EQ 4.5MG BASE	CAPSULE / ORAL		2007-10-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077131-004	RIVASTIGMINE TARTRATE	EQ 6MG BASE	CAPSULE / ORAL		2007-10-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077131-001	RIVASTIGMINE TARTRATE	EQ 1.5MG BASE	CAPSULE / ORAL		2007-10-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077131-002	RIVASTIGMINE TARTRATE	EQ 3MG BASE	CAPSULE / ORAL		2007-10-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077131-003	RIVASTIGMINE TARTRATE	EQ 4.5MG BASE	CAPSULE / ORAL		2007-10-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077131-004	RIVASTIGMINE TARTRATE	EQ 6MG BASE	CAPSULE / ORAL		2007-10-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077131-001	RIVASTIGMINE TARTRATE	EQ 1.5MG BASE	CAPSULE / ORAL		2007-10-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077131-002	RIVASTIGMINE TARTRATE	EQ 3MG BASE	CAPSULE / ORAL		2007-10-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077131-003	RIVASTIGMINE TARTRATE	EQ 4.5MG BASE	CAPSULE / ORAL		2007-10-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077131-004	RIVASTIGMINE TARTRATE	EQ 6MG BASE	CAPSULE / ORAL		2007-10-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077131-001	RIVASTIGMINE TARTRATE	EQ 1.5MG BASE	CAPSULE / ORAL		2007-10-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077131-002	RIVASTIGMINE TARTRATE	EQ 3MG BASE	CAPSULE / ORAL		2007-10-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077131-003	RIVASTIGMINE TARTRATE	EQ 4.5MG BASE	CAPSULE / ORAL		2007-10-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077131-004	RIVASTIGMINE TARTRATE	EQ 6MG BASE	CAPSULE / ORAL		2007-10-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077131-001	RIVASTIGMINE TARTRATE	EQ 1.5MG BASE	CAPSULE / ORAL		2007-10-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077131-002	RIVASTIGMINE TARTRATE	EQ 3MG BASE	CAPSULE / ORAL		2007-10-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077131-003	RIVASTIGMINE TARTRATE	EQ 4.5MG BASE	CAPSULE / ORAL		2007-10-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077131-004	RIVASTIGMINE TARTRATE	EQ 6MG BASE	CAPSULE / ORAL		2007-10-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077131-001	RIVASTIGMINE TARTRATE	EQ 1.5MG BASE	CAPSULE / ORAL	AB	2007-10-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077131-002	RIVASTIGMINE TARTRATE	EQ 3MG BASE	CAPSULE / ORAL	AB	2007-10-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077131-003	RIVASTIGMINE TARTRATE	EQ 4.5MG BASE	CAPSULE / ORAL	AB	2007-10-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077131-004	RIVASTIGMINE TARTRATE	EQ 6MG BASE	CAPSULE / ORAL	AB	2007-10-22	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 4 · 128 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-03-09 01:35 UTC	2022-03	A077131-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A077131-002	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A077131-003	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A077131-004	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077131-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A077131-002	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A077131-003	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A077131-004	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077131-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077131-002	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077131-003	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077131-004	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077131-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A077131-002	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A077131-003	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A077131-004	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077131-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A077131-002	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A077131-003	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A077131-004	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077131-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A077131-002	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A077131-003	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A077131-004	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077131-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A077131-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A077131-003	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A077131-004	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077131-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A077131-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A077131-003	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A077131-004	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077131-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A077131-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A077131-003	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A077131-004	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077131-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077131-002	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077131-003	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077131-004	AB	1	`6a51e52b5d6a…`

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
Rivastigmine Tartrate	RIVASTIGMINE TARTRATE	Sun Pharmaceutical Industries, Inc.	bac9ca81-db70-41aa-82af-6c5bb8496846	2019-01-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077131 application number: ANDA077131 ndc (product): 62756-148 ndc (product): 62756-146 ndc (product): 62756-147 ndc (product): 62756-145

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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
62756-145	Rivastigmine Tartrate	Rivastigmine Tartrate	Sun Pharmaceutical Industries, Inc.	ANDA	Current
62756-146	Rivastigmine Tartrate	Rivastigmine Tartrate	Sun Pharmaceutical Industries, Inc.	ANDA	Current
62756-147	Rivastigmine Tartrate	Rivastigmine Tartrate	Sun Pharmaceutical Industries, Inc.	ANDA	Current
62756-148	Rivastigmine Tartrate	Rivastigmine Tartrate	Sun Pharmaceutical Industries, Inc.	ANDA	Current
68084-550	Rivastigmine Tartrate	Rivastigmine Tartrate	American Health Packaging	ANDA	Current
68084-550	Rivastigmine Tartrate	Rivastigmine Tartrate	American Health Packaging	ANDA	Current
68084-550	Rivastigmine Tartrate	Rivastigmine Tartrate	American Health Packaging	ANDA	Current
68151-4134	Rivastigmine Tartrate	Rivastigmine Tartrate	Carilion Materials Management	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
31200	ORIG	2007-10-25