Application 019899

Type: NDA
Sponsor: J AND J CONSUMER INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	SINE-AID IB	IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE	TABLET;ORAL	200MG;30MG	No	No

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N019899-001	SINE-AID IB	IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE	200MG;30MG	TABLET / ORAL			1992-12-31

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 2 · 44 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	N019899-001	SINE-AID IB	200MG;30MG	TABLET / ORAL	1992-12-31	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N019899-001	SINE-AID IB	200MG;30MG	TABLET / ORAL	1992-12-31	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N019899-001	SINE-AID IB	200MG;30MG	TABLET / ORAL	1992-12-31	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N019899-001	SINE-AID IB	200MG;30MG	TABLET / ORAL	1992-12-31	`a50c72e98297…`

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
69450	SUPPL	2021-12-02
69449	SUPPL	2021-12-02
48396	SUPPL	2017-05-17
48390	SUPPL	2017-05-17
19815	SUPPL	2006-03-01
19814	SUPPL	2004-06-09
34082	SUPPL	2003-08-06
19813	SUPPL	2002-09-03
19812	SUPPL	2002-09-03
1789	SUPPL	2002-09-03