Application 009668

Type: NDA
Sponsor: VALEANT PHARM INTL

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	RAUWOLFIA SERPENTINA	RAUWOLFIA SERPENTINA ROOT	TABLET;ORAL	50MG	No	No
002	RAUWOLFIA SERPENTINA	RAUWOLFIA SERPENTINA ROOT	TABLET;ORAL	100MG	No	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
N009668-001	RAUWOLFIA SERPENTINA	RAUWOLFIA SERPENTINA ROOT	50MG	TABLET / ORAL		Approved before 1982
N009668-002	RAUWOLFIA SERPENTINA	RAUWOLFIA SERPENTINA ROOT	100MG	TABLET / ORAL		Approved before 1982

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	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N009668-001	RAUWOLFIA SERPENTINA	50MG	TABLET / ORAL	Approved before 1982	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N009668-002	RAUWOLFIA SERPENTINA	100MG	TABLET / ORAL	Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N009668-001	RAUWOLFIA SERPENTINA	50MG	TABLET / ORAL	Approved before 1982	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N009668-002	RAUWOLFIA SERPENTINA	100MG	TABLET / ORAL	Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N009668-001	RAUWOLFIA SERPENTINA	50MG	TABLET / ORAL	Approved before 1982	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N009668-002	RAUWOLFIA SERPENTINA	100MG	TABLET / ORAL	Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N009668-001	RAUWOLFIA SERPENTINA	50MG	TABLET / ORAL	Approved before 1982	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N009668-002	RAUWOLFIA SERPENTINA	100MG	TABLET / ORAL	Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N009668-001	RAUWOLFIA SERPENTINA	50MG	TABLET / ORAL	Approved before 1982	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N009668-002	RAUWOLFIA SERPENTINA	100MG	TABLET / ORAL	Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N009668-001	RAUWOLFIA SERPENTINA	50MG	TABLET / ORAL	Approved before 1982	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N009668-002	RAUWOLFIA SERPENTINA	100MG	TABLET / ORAL	Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N009668-001	RAUWOLFIA SERPENTINA	50MG	TABLET / ORAL	Approved before 1982	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N009668-002	RAUWOLFIA SERPENTINA	100MG	TABLET / ORAL	Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N009668-001	RAUWOLFIA SERPENTINA	50MG	TABLET / ORAL	Approved before 1982	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N009668-002	RAUWOLFIA SERPENTINA	100MG	TABLET / ORAL	Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N009668-001	RAUWOLFIA SERPENTINA	50MG	TABLET / ORAL	Approved before 1982	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N009668-002	RAUWOLFIA SERPENTINA	100MG	TABLET / ORAL	Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N009668-001	RAUWOLFIA SERPENTINA	50MG	TABLET / ORAL	Approved before 1982	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N009668-002	RAUWOLFIA SERPENTINA	100MG	TABLET / ORAL	Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N009668-001	RAUWOLFIA SERPENTINA	50MG	TABLET / ORAL	Approved before 1982	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N009668-002	RAUWOLFIA SERPENTINA	100MG	TABLET / ORAL	Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N009668-001	RAUWOLFIA SERPENTINA	50MG	TABLET / ORAL	Approved before 1982	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N009668-002	RAUWOLFIA SERPENTINA	100MG	TABLET / ORAL	Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N009668-001	RAUWOLFIA SERPENTINA	50MG	TABLET / ORAL	Approved before 1982	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N009668-002	RAUWOLFIA SERPENTINA	100MG	TABLET / ORAL	Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N009668-001	RAUWOLFIA SERPENTINA	50MG	TABLET / ORAL	Approved before 1982	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N009668-002	RAUWOLFIA SERPENTINA	100MG	TABLET / ORAL	Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N009668-001	RAUWOLFIA SERPENTINA	50MG	TABLET / ORAL	Approved before 1982	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N009668-002	RAUWOLFIA SERPENTINA	100MG	TABLET / ORAL	Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N009668-001	RAUWOLFIA SERPENTINA	50MG	TABLET / ORAL	Approved before 1982	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N009668-002	RAUWOLFIA SERPENTINA	100MG	TABLET / ORAL	Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N009668-001	RAUWOLFIA SERPENTINA	50MG	TABLET / ORAL	Approved before 1982	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N009668-002	RAUWOLFIA SERPENTINA	100MG	TABLET / ORAL	Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N009668-001	RAUWOLFIA SERPENTINA	50MG	TABLET / ORAL	Approved before 1982	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N009668-002	RAUWOLFIA SERPENTINA	100MG	TABLET / ORAL	Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N009668-001	RAUWOLFIA SERPENTINA	50MG	TABLET / ORAL	Approved before 1982	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N009668-002	RAUWOLFIA SERPENTINA	100MG	TABLET / ORAL	Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N009668-001	RAUWOLFIA SERPENTINA	50MG	TABLET / ORAL	Approved before 1982	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N009668-002	RAUWOLFIA SERPENTINA	100MG	TABLET / ORAL	Approved before 1982	`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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Rauwolfia Serpentina	RAUWOLFIA SERPENTINA	Hahnemann Laboratories, INC.	e70519b5-2ea1-9f70-e053-2a95a90a8395	2022-08-24		Name fallback brand name: Rauwolfia Serpentina
RAUWOLFIA SERPENTINA	RAUWOLFIA SERPENTINA	Rxhomeo Private Limited d.b.a. Rxhomeo, Inc	c233b42f-62b8-4b81-b914-3ba457a931af	2021-09-26	Warnings	Name fallback brand name: RAUWOLFIA SERPENTINA

Reported adverse events (FAERS/openFDA)#

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