Application 018285

Type: NDA
Sponsor: NOVARTIS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	VISKEN	PINDOLOL	TABLET;ORAL	5MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
002	VISKEN	PINDOLOL	TABLET;ORAL	10MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
N018285-001	VISKEN	PINDOLOL	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1982-09-03
N018285-002	VISKEN	PINDOLOL	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1982-09-03

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 2 of 3 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N018285-001	VISKEN	5MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1982-09-03	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N018285-002	VISKEN	10MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1982-09-03	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N018285-001	VISKEN	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1982-09-03	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N018285-002	VISKEN	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1982-09-03	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N018285-001	VISKEN	5MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1982-09-03	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N018285-002	VISKEN	10MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1982-09-03	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N018285-001	VISKEN	5MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1982-09-03	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N018285-002	VISKEN	10MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1982-09-03	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N018285-001	VISKEN	5MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1982-09-03	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N018285-002	VISKEN	10MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1982-09-03	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N018285-001	VISKEN	5MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1982-09-03	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N018285-002	VISKEN	10MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1982-09-03	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N018285-001	VISKEN	5MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1982-09-03	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N018285-002	VISKEN	10MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1982-09-03	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N018285-001	VISKEN	5MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1982-09-03	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N018285-002	VISKEN	10MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1982-09-03	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N018285-001	VISKEN	5MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1982-09-03	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N018285-002	VISKEN	10MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1982-09-03	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N018285-001	VISKEN	5MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1982-09-03	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N018285-002	VISKEN	10MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1982-09-03	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N018285-001	VISKEN	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1982-09-03	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N018285-002	VISKEN	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1982-09-03	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N018285-001	VISKEN	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1982-09-03	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N018285-002	VISKEN	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1982-09-03	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N018285-001	VISKEN	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1982-09-03	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N018285-002	VISKEN	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1982-09-03	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N018285-001	VISKEN	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1982-09-03	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N018285-002	VISKEN	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1982-09-03	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N018285-001	VISKEN	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1982-09-03	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N018285-002	VISKEN	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1982-09-03	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N018285-001	VISKEN	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1982-09-03	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N018285-002	VISKEN	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1982-09-03	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N018285-001	VISKEN	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1982-09-03	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N018285-002	VISKEN	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1982-09-03	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N018285-001	VISKEN	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1982-09-03	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N018285-002	VISKEN	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1982-09-03	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N018285-001	VISKEN	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1982-09-03	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N018285-002	VISKEN	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1982-09-03	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N018285-001	VISKEN	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1982-09-03	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N018285-002	VISKEN	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1982-09-03	`3a93d1ddd44b…`

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 · 11 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Pindolol	PINDOLOL	PD-Rx Pharmaceuticals, Inc.	0daed7b3-6017-4611-8c3a-2f390470f8bc	2026-07-17	Warnings, Adverse reactions	Name fallback generic name: PINDOLOL
Pindolol	PINDOLOL	PD-Rx Pharmaceuticals, Inc.	79a8d97b-9461-4914-bcbb-f6f64a39e5e7	2026-07-17	Warnings, Adverse reactions	Name fallback generic name: PINDOLOL
Pindolol	PINDOLOL	Bryant Ranch Prepack	8498aead-0aef-4cd8-a191-05cae57a55e5	2026-05-27	Warnings, Adverse reactions	Name fallback generic name: PINDOLOL
Pindolol	PINDOLOL	Bryant Ranch Prepack	22b95e96-ead9-4149-badb-7d33077e82ec	2026-05-27	Warnings, Adverse reactions	Name fallback generic name: PINDOLOL
Pindolol	PINDOLOL	Sun Pharmaceutical Industries, Inc.	b331a73f-bf7b-4442-8901-36d016530279	2026-03-17	Warnings, Adverse reactions	Name fallback generic name: PINDOLOL
Pindolol	PINDOLOL	Marlex Pharmaceuticals, Inc.	e1049edf-376e-317b-e053-2995a90a2aac	2026-02-06	Warnings, Adverse reactions	Name fallback generic name: PINDOLOL
Pindolol	PINDOLOL	PD-Rx Pharmaceuticals, Inc.	f91e5715-e37d-45fa-97a7-4d32fbd51060	2026-01-12	Warnings, Adverse reactions	Name fallback generic name: PINDOLOL
Pindolol	PINDOLOL	Unichem Pharmaceuticals (USA), Inc.	f529ff35-f82b-4a3a-96b4-096bfc8e81b5	2025-12-11	Warnings, Adverse reactions	Name fallback generic name: PINDOLOL
Pindolol	PINDOLOL	Westminster Pharmaceuticals, LLC	efdb0189-37b5-45d6-b92c-1157bb9df789	2025-11-25	Warnings, Adverse reactions	Name fallback generic name: PINDOLOL
Pindolol	PINDOLOL	ANI Pharmaceuticals, Inc.	611be921-e9b6-4800-80b2-c2d4f677cdb2	2025-09-19	Warnings, Adverse reactions	Name fallback generic name: PINDOLOL
Pindolol	PINDOLOL	Bryant Ranch Prepack	7fb36f8f-11fe-498e-8667-daeccf8b2273	2024-11-25	Warnings, Adverse reactions	Name fallback generic name: PINDOLOL

Reported adverse events (FAERS/openFDA)#

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

Documents#

Document, Submission type, Date table
Document	Submission type	Date
891	SUPPL	2007-11-08
11199	SUPPL	2007-11-07