Application 018976

Type: NDA
Sponsor: AUXILIUM PHARMS LLC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LEVATOL	PENBUTOLOL SULFATE	TABLET;ORAL	10MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
004	LEVATOL	PENBUTOLOL SULFATE	TABLET;ORAL	20MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No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
N018976-001	LEVATOL	PENBUTOLOL SULFATE	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1987-12-30
N018976-004	LEVATOL	PENBUTOLOL SULFATE	20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1989-01-05

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UTC	2019-12	N018976-001	LEVATOL	10MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1987-12-30	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N018976-004	LEVATOL	20MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1989-01-05	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N018976-001	LEVATOL	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1987-12-30	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N018976-004	LEVATOL	20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1989-01-05	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N018976-001	LEVATOL	10MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1987-12-30	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N018976-004	LEVATOL	20MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1989-01-05	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N018976-001	LEVATOL	10MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1987-12-30	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N018976-004	LEVATOL	20MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1989-01-05	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N018976-001	LEVATOL	10MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1987-12-30	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N018976-004	LEVATOL	20MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1989-01-05	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N018976-001	LEVATOL	10MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1987-12-30	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N018976-004	LEVATOL	20MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1989-01-05	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N018976-001	LEVATOL	10MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1987-12-30	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N018976-004	LEVATOL	20MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1989-01-05	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N018976-001	LEVATOL	10MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1987-12-30	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N018976-004	LEVATOL	20MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1989-01-05	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N018976-001	LEVATOL	10MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1987-12-30	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N018976-004	LEVATOL	20MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1989-01-05	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N018976-001	LEVATOL	10MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1987-12-30	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N018976-004	LEVATOL	20MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1989-01-05	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N018976-001	LEVATOL	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1987-12-30	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N018976-004	LEVATOL	20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1989-01-05	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N018976-001	LEVATOL	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1987-12-30	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N018976-004	LEVATOL	20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1989-01-05	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N018976-001	LEVATOL	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1987-12-30	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N018976-004	LEVATOL	20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1989-01-05	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N018976-001	LEVATOL	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1987-12-30	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N018976-004	LEVATOL	20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1989-01-05	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N018976-001	LEVATOL	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1987-12-30	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N018976-004	LEVATOL	20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1989-01-05	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N018976-001	LEVATOL	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1987-12-30	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N018976-004	LEVATOL	20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1989-01-05	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N018976-001	LEVATOL	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1987-12-30	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N018976-004	LEVATOL	20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1989-01-05	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N018976-001	LEVATOL	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1987-12-30	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N018976-004	LEVATOL	20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1989-01-05	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N018976-001	LEVATOL	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1987-12-30	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N018976-004	LEVATOL	20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1989-01-05	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N018976-001	LEVATOL	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1987-12-30	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N018976-004	LEVATOL	20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1989-01-05	`3a93d1ddd44b…`

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
11400	SUPPL	2011-05-05