Application 086101

Type: ANDA
Sponsor: VALEANT PHARMS NORTH

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	SECONAL SODIUM	SECOBARBITAL SODIUM	CAPSULE;ORAL	50MG	No	Yes
002	SECONAL SODIUM	SECOBARBITAL SODIUM	CAPSULE;ORAL	100MG	No	Yes

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
A086101-001	SECONAL SODIUM	SECOBARBITAL SODIUM	50MG	CAPSULE / ORAL			1983-10-03
A086101-002	SECONAL SODIUM	SECOBARBITAL SODIUM	100MG	CAPSULE / ORAL			1983-10-03

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 3 of 3 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2022-10-28 04:53 UTC	2022-10	A086101-001	SECONAL SODIUM	50MG	CAPSULE / ORAL	1983-10-03	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A086101-002	SECONAL SODIUM	100MG	CAPSULE / ORAL	1983-10-03	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A086101-001	SECONAL SODIUM	50MG	CAPSULE / ORAL	1983-10-03	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A086101-002	SECONAL SODIUM	100MG	CAPSULE / ORAL	1983-10-03	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A086101-001	SECONAL SODIUM	50MG	CAPSULE / ORAL	1983-10-03	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A086101-002	SECONAL SODIUM	100MG	CAPSULE / ORAL	1983-10-03	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A086101-001	SECONAL SODIUM	50MG	CAPSULE / ORAL	1983-10-03	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A086101-002	SECONAL SODIUM	100MG	CAPSULE / ORAL	1983-10-03	`a50c72e98297…`

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 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0187-4220	Seconal Sodium	secobarbital sodium	Bausch Health US, LLC	ANDA	Current
0187-4220	Seconal Sodium	secobarbital sodium	Valeant Pharmaceuticals North America LLC	ANDA	Current
0187-4220	Seconal Sodium	secobarbital sodium	Valeant Pharmaceuticals North America LLC	ANDA	Current
0187-4220	Seconal Sodium	secobarbital sodium	Bausch Health US, LLC	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
23932	ORIG	2007-03-16