Application 206318

Type: ANDA
Sponsor: ZYDUS NOVELTECH INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	RIVASTIGMINE	RIVASTIGMINE	FILM, EXTENDED RELEASE;TRANSDERMAL	4.6MG/24HR	No	No
002	RIVASTIGMINE	RIVASTIGMINE	FILM, EXTENDED RELEASE;TRANSDERMAL	9.5MG/24HR	No	No
003	RIVASTIGMINE	RIVASTIGMINE	FILM, EXTENDED RELEASE;TRANSDERMAL	13.3MG/24HR	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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	Approval date
A206318-001	RIVASTIGMINE	RIVASTIGMINE	4.6MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2019-03-04
A206318-002	RIVASTIGMINE	RIVASTIGMINE	9.5MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2019-03-04
A206318-003	RIVASTIGMINE	RIVASTIGMINE	13.3MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2019-03-04

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A206318-001	AB
A206318-002	AB
A206318-003	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 · 123 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	A206318-001	RIVASTIGMINE	4.6MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2019-03-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206318-002	RIVASTIGMINE	9.5MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2019-03-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206318-003	RIVASTIGMINE	13.3MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2019-03-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206318-001	RIVASTIGMINE	4.6MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2019-03-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206318-002	RIVASTIGMINE	9.5MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2019-03-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206318-003	RIVASTIGMINE	13.3MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2019-03-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206318-001	RIVASTIGMINE	4.6MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2019-03-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206318-002	RIVASTIGMINE	9.5MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2019-03-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206318-003	RIVASTIGMINE	13.3MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2019-03-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206318-001	RIVASTIGMINE	4.6MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2019-03-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206318-002	RIVASTIGMINE	9.5MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2019-03-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206318-003	RIVASTIGMINE	13.3MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2019-03-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206318-001	RIVASTIGMINE	4.6MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2019-03-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206318-002	RIVASTIGMINE	9.5MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2019-03-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206318-003	RIVASTIGMINE	13.3MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2019-03-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206318-001	RIVASTIGMINE	4.6MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2019-03-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206318-002	RIVASTIGMINE	9.5MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2019-03-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206318-003	RIVASTIGMINE	13.3MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2019-03-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206318-001	RIVASTIGMINE	4.6MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2019-03-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206318-002	RIVASTIGMINE	9.5MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2019-03-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206318-003	RIVASTIGMINE	13.3MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2019-03-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206318-001	RIVASTIGMINE	4.6MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2019-03-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206318-002	RIVASTIGMINE	9.5MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2019-03-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206318-003	RIVASTIGMINE	13.3MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2019-03-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206318-001	RIVASTIGMINE	4.6MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2019-03-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206318-002	RIVASTIGMINE	9.5MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2019-03-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206318-003	RIVASTIGMINE	13.3MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2019-03-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206318-001	RIVASTIGMINE	4.6MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2019-03-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206318-002	RIVASTIGMINE	9.5MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2019-03-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206318-003	RIVASTIGMINE	13.3MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2019-03-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206318-001	RIVASTIGMINE	4.6MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2019-03-04	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206318-002	RIVASTIGMINE	9.5MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2019-03-04	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206318-003	RIVASTIGMINE	13.3MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2019-03-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206318-001	RIVASTIGMINE	4.6MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2019-03-04	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206318-002	RIVASTIGMINE	9.5MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2019-03-04	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206318-003	RIVASTIGMINE	13.3MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2019-03-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206318-001	RIVASTIGMINE	4.6MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2019-03-04	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206318-002	RIVASTIGMINE	9.5MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2019-03-04	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206318-003	RIVASTIGMINE	13.3MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2019-03-04	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206318-001	RIVASTIGMINE	4.6MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2019-03-04	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 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	A206318-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206318-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206318-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206318-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206318-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206318-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206318-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206318-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206318-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206318-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206318-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206318-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206318-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206318-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206318-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206318-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206318-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206318-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206318-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206318-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206318-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206318-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206318-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206318-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206318-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206318-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206318-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206318-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206318-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206318-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206318-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206318-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206318-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206318-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206318-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206318-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206318-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206318-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206318-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206318-001	AB	1	`8072bd15b7f6…`

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Rivastigmine	RIVASTIGMINE	Zydus Lifesciences Limited	966d59ea-5cea-4fef-8b96-e0efe885caf4	2025-11-17		Exact identifier application applno (ANDA): 206318 application number: ANDA206318
Rivastigmine	RIVASTIGMINE	Northstar Rx LLC.	8b809739-8381-4cc1-ab4a-5b17ab902a3d	2025-11-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206318 application number: ANDA206318 ndc (product): 16714-115 ndc (product): 16714-116 ndc (product): 16714-117
Rivastigmine	RIVASTIGMINE	Zydus Pharmaceuticals USA Inc.	64dad603-2389-456b-8c18-d1d40b7e7419	2024-05-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206318 application number: ANDA206318 ndc (product): 70710-1196 ndc (product): 70710-1197 ndc (product): 70710-1198

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 27 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
16714-115	Rivastigmine	Rivastigmine	Northstar Rx LLC.	ANDA	Current
16714-115	Rivastigmine	Rivastigmine	Northstar Rx LLC.	ANDA	Current
16714-115	Rivastigmine	Rivastigmine	Northstar Rx LLC.	ANDA	Current
16714-116	Rivastigmine	Rivastigmine	Northstar Rx LLC.	ANDA	Current
16714-116	Rivastigmine	Rivastigmine	Northstar Rx LLC.	ANDA	Current
16714-116	Rivastigmine	Rivastigmine	Northstar Rx LLC.	ANDA	Current
16714-117	Rivastigmine	Rivastigmine	Northstar Rx LLC.	ANDA	Current
16714-117	Rivastigmine	Rivastigmine	Northstar Rx LLC.	ANDA	Current
16714-117	Rivastigmine	Rivastigmine	Northstar Rx LLC.	ANDA	Current
51956-0001	Rivastigmine	Rivastigmine	Zydus Lifesciences Limited	ANDA	Current
51956-0001	Rivastigmine	Rivastigmine	Cadila Healthcare Limited	ANDA	Current
51956-0001	Rivastigmine	Rivastigmine	Zydus Technologies Limited	ANDA	Current
51956-0002	Rivastigmine	Rivastigmine	Zydus Lifesciences Limited	ANDA	Current
51956-0002	Rivastigmine	Rivastigmine	Cadila Healthcare Limited	ANDA	Current
51956-0002	Rivastigmine	Rivastigmine	Zydus Technologies Limited	ANDA	Current
51956-0003	Rivastigmine	Rivastigmine	Zydus Lifesciences Limited	ANDA	Current
51956-0003	Rivastigmine	Rivastigmine	Cadila Healthcare Limited	ANDA	Current
51956-0003	Rivastigmine	Rivastigmine	Zydus Technologies Limited	ANDA	Current
70710-1196	Rivastigmine	Rivastigmine	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70710-1196	Rivastigmine	Rivastigmine	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70710-1196	Rivastigmine	Rivastigmine	Zydus Pharmaceuticals USA Inc.	ANDA	Current
70710-1197	Rivastigmine	Rivastigmine	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70710-1197	Rivastigmine	Rivastigmine	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70710-1197	Rivastigmine	Rivastigmine	Zydus Pharmaceuticals USA Inc.	ANDA	Current
70710-1198	Rivastigmine	Rivastigmine	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70710-1198	Rivastigmine	Rivastigmine	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70710-1198	Rivastigmine	Rivastigmine	Zydus Pharmaceuticals USA Inc.	ANDA	Current