Application 207605

Type: ANDA
Sponsor: APOTEX

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TOLVAPTAN	TOLVAPTAN	TABLET;ORAL	30MG	No	No
002	TOLVAPTAN	TOLVAPTAN	TABLET;ORAL	15MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A207605-001	TOLVAPTAN	TOLVAPTAN	30MG	TABLET / ORAL	AB1		2020-05-19
A207605-002	TOLVAPTAN	TOLVAPTAN	15MG	TABLET / ORAL	AB1		2022-09-06

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A207605-001	AB1
A207605-002	AB1

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 2 · 68 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	A207605-001	TOLVAPTAN	30MG	TABLET / ORAL	AB1	2020-05-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207605-002	TOLVAPTAN	15MG	TABLET / ORAL	AB1	2022-09-06	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A207605-001	TOLVAPTAN	30MG	TABLET / ORAL	AB1	2020-05-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207605-002	TOLVAPTAN	15MG	TABLET / ORAL	AB1	2022-09-06	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207605-001	TOLVAPTAN	30MG	TABLET / ORAL	AB1	2020-05-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207605-002	TOLVAPTAN	15MG	TABLET / ORAL	AB1	2022-09-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207605-001	TOLVAPTAN	30MG	TABLET / ORAL	AB1	2020-05-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207605-002	TOLVAPTAN	15MG	TABLET / ORAL	AB1	2022-09-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207605-001	TOLVAPTAN	30MG	TABLET / ORAL	AB1	2020-05-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207605-002	TOLVAPTAN	15MG	TABLET / ORAL	AB1	2022-09-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207605-001	TOLVAPTAN	30MG	TABLET / ORAL	AB	2020-05-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207605-002	TOLVAPTAN	15MG	TABLET / ORAL	AB	2022-09-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207605-001	TOLVAPTAN	30MG	TABLET / ORAL	AB	2020-05-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207605-002	TOLVAPTAN	15MG	TABLET / ORAL	AB	2022-09-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207605-001	TOLVAPTAN	30MG	TABLET / ORAL	AB	2020-05-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207605-002	TOLVAPTAN	15MG	TABLET / ORAL	AB	2022-09-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207605-001	TOLVAPTAN	30MG	TABLET / ORAL	AB	2020-05-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207605-002	TOLVAPTAN	15MG	TABLET / ORAL	AB	2022-09-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207605-001	TOLVAPTAN	30MG	TABLET / ORAL	AB	2020-05-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207605-002	TOLVAPTAN	15MG	TABLET / ORAL	AB	2022-09-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207605-001	TOLVAPTAN	30MG	TABLET / ORAL	AB	2020-05-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207605-002	TOLVAPTAN	15MG	TABLET / ORAL	AB	2022-09-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207605-001	TOLVAPTAN	30MG	TABLET / ORAL	AB	2020-05-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207605-002	TOLVAPTAN	15MG	TABLET / ORAL	AB	2022-09-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207605-001	TOLVAPTAN	30MG	TABLET / ORAL	AB	2020-05-19	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207605-002	TOLVAPTAN	15MG	TABLET / ORAL	AB	2022-09-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207605-001	TOLVAPTAN	30MG	TABLET / ORAL	AB	2020-05-19	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207605-002	TOLVAPTAN	15MG	TABLET / ORAL	AB	2022-09-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207605-001	TOLVAPTAN	30MG	TABLET / ORAL	AB	2020-05-19	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207605-002	TOLVAPTAN	15MG	TABLET / ORAL	AB	2022-09-06	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207605-001	TOLVAPTAN	30MG	TABLET / ORAL	AB	2020-05-19	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A207605-002	TOLVAPTAN	15MG	TABLET / ORAL	AB	2022-09-06	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207605-001	TOLVAPTAN	30MG	TABLET / ORAL	AB	2020-05-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207605-001	TOLVAPTAN	30MG	TABLET / ORAL	AB	2020-05-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207605-001	TOLVAPTAN	30MG	TABLET / ORAL	AB	2020-05-19	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A207605-001	TOLVAPTAN	30MG	TABLET / ORAL	AB	2020-05-19	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207605-001	TOLVAPTAN	30MG	TABLET / ORAL	AB	2020-05-19	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207605-001	TOLVAPTAN	30MG	TABLET / ORAL		2020-05-19	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207605-001	TOLVAPTAN	30MG	TABLET / ORAL		2020-05-19	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A207605-001	TOLVAPTAN	30MG	TABLET / ORAL		2020-05-19	`8869cabd3fbd…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 65 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A207605-001	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207605-002	AB1	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A207605-001	AB1	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207605-002	AB1	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207605-001	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207605-002	AB1	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207605-001	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207605-002	AB1	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207605-001	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207605-002	AB1	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207605-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207605-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207605-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207605-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207605-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207605-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207605-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207605-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207605-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207605-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207605-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207605-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207605-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207605-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207605-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207605-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207605-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207605-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207605-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207605-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207605-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A207605-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207605-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207605-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207605-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A207605-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207605-001	AB	1	`782e0a99824c…`
2020-11-12 02:37 UTC	2020-11	A207605-001	AB	1	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207605-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207605-002	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 · 10 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tolvaptan	TOLVAPTAN	Ascend Laboratories, LLC	82ef58ef-ce46-434e-bf99-89fce51094f1	2026-08-26	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Tolvaptan generic name: TOLVAPTAN
Tolvaptan	TOLVAPTAN	Par Health USA, LLC	5b14ba2b-9f80-41d6-9613-f16d3cf37d25	2026-08-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Tolvaptan generic name: TOLVAPTAN
SAMSCA	TOLVAPTAN	Otsuka America Pharmaceutical, Inc.	5526617c-c7b9-4556-886d-729bbabbc566	2026-05-07	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: TOLVAPTAN
TOLVAPTAN	TOLVAPTAN	Northstar Rx LLC	c075d517-f4c8-469a-9f51-416ef61c6a83	2026-04-24	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: TOLVAPTAN generic name: TOLVAPTAN
Jynarque	TOLVAPTAN	Otsuka America Pharmaceutical, Inc.	3febc0a1-9e5a-4ce0-843d-210f21d862c4	2025-11-06	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: TOLVAPTAN
TOLVAPTAN	TOLVAPTAN	Lupin Pharmaceuticals, Inc.	9ba38e23-ca66-4406-92af-bbb8fad00e16	2025-05-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: TOLVAPTAN generic name: TOLVAPTAN
Tolvaptan	TOLVAPTAN	Teva Pharmaceuticals, Inc.	808a9a1f-2f58-4677-9127-e749ad007094	2025-03-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Tolvaptan generic name: TOLVAPTAN
TOLVAPTAN	TOLVAPTAN	Novadoz Pharmaceuticals LLC	92ce12f1-eae0-4c83-9a4e-a5181e08fa92	2023-06-14	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: TOLVAPTAN generic name: TOLVAPTAN
Tolvaptan	TOLVAPTAN	Ascend Laboratories, LLC	dd71ee70-9435-4715-bee5-edbb5a8d7d7b	2022-09-07	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Tolvaptan generic name: TOLVAPTAN
Tolvaptan	TOLVAPTAN	Camber Pharmaceuticals, Inc.	6f4c5679-8490-45ec-bd34-1a569e3af850	2022-09-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Tolvaptan generic name: TOLVAPTAN

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 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
60505-4317	tolvaptan	tolvaptan	Apotex Corp.	ANDA	Current
60505-4317	tolvaptan	tolvaptan	Apotex Corp.	ANDA	Current
60505-4318	tolvaptan	tolvaptan	Apotex Corp.	ANDA	Current
60505-4318	tolvaptan	tolvaptan	Apotex Corp.	ANDA	Current
60505-4318	tolvaptan	tolvaptan	Apotex Corp.	ANDA	Current
60505-4318	tolvaptan	tolvaptan	Apotex Corp.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
63415	ORIG	2020-06-04