Application 050686

Type: NDA
Sponsor: SI PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CEDAX	CEFTIBUTEN DIHYDRATE	FOR SUSPENSION;ORAL	EQ 90MG BASE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
002	CEDAX	CEFTIBUTEN DIHYDRATE	FOR SUSPENSION;ORAL	EQ 180MG BASE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No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
N050686-001	CEDAX	CEFTIBUTEN DIHYDRATE	EQ 90MG BASE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION / ORAL		RLD	1995-12-20
N050686-002	CEDAX	CEFTIBUTEN DIHYDRATE	EQ 180MG BASE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION / ORAL		RLD	1995-12-20

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 1 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
2026-10-15 13:18:30	2026-09	N050686-001	CEDAX	EQ 90MG BASE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION / ORAL	RLD	1995-12-20	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N050686-002	CEDAX	EQ 180MG BASE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION / ORAL	RLD	1995-12-20	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N050686-001	CEDAX	EQ 90MG BASE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION / ORAL	RLD	1995-12-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N050686-002	CEDAX	EQ 180MG BASE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION / ORAL	RLD	1995-12-20	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N050686-001	CEDAX	EQ 90MG BASE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION / ORAL	RLD	1995-12-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N050686-002	CEDAX	EQ 180MG BASE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION / ORAL	RLD	1995-12-20	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N050686-001	CEDAX	EQ 90MG BASE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION / ORAL	RLD	1995-12-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N050686-002	CEDAX	EQ 180MG BASE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION / ORAL	RLD	1995-12-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050686-001	CEDAX	EQ 90MG BASE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION / ORAL	RLD	1995-12-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050686-002	CEDAX	EQ 180MG BASE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION / ORAL	RLD	1995-12-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N050686-001	CEDAX	EQ 90MG BASE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION / ORAL	RLD	1995-12-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N050686-002	CEDAX	EQ 180MG BASE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION / ORAL	RLD	1995-12-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050686-001	CEDAX	EQ 90MG BASE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION / ORAL	RLD	1995-12-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050686-002	CEDAX	EQ 180MG BASE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION / ORAL	RLD	1995-12-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050686-001	CEDAX	EQ 90MG BASE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION / ORAL	RLD	1995-12-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050686-002	CEDAX	EQ 180MG BASE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION / ORAL	RLD	1995-12-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050686-001	CEDAX	EQ 90MG BASE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION / ORAL	RLD	1995-12-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050686-002	CEDAX	EQ 180MG BASE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION / ORAL	RLD	1995-12-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050686-001	CEDAX	EQ 90MG BASE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION / ORAL	RLD	1995-12-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050686-002	CEDAX	EQ 180MG BASE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION / ORAL	RLD	1995-12-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050686-001	CEDAX	EQ 90MG BASE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION / ORAL	RLD	1995-12-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050686-002	CEDAX	EQ 180MG BASE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION / ORAL	RLD	1995-12-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050686-001	CEDAX	EQ 90MG BASE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION / ORAL	RLD	1995-12-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050686-002	CEDAX	EQ 180MG BASE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION / ORAL	RLD	1995-12-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N050686-001	CEDAX	EQ 90MG BASE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION / ORAL	RLD	1995-12-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N050686-002	CEDAX	EQ 180MG BASE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION / ORAL	RLD	1995-12-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050686-001	CEDAX	EQ 90MG BASE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION / ORAL	RLD	1995-12-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050686-002	CEDAX	EQ 180MG BASE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION / ORAL	RLD	1995-12-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050686-001	CEDAX	EQ 90MG BASE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION / ORAL	RLD	1995-12-20	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050686-002	CEDAX	EQ 180MG BASE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION / ORAL	RLD	1995-12-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050686-001	CEDAX	EQ 90MG BASE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION / ORAL	RLD	1995-12-20	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050686-002	CEDAX	EQ 180MG BASE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION / ORAL	RLD	1995-12-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N050686-001	CEDAX	EQ 90MG BASE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION / ORAL	RLD	1995-12-20	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N050686-002	CEDAX	EQ 180MG BASE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION / ORAL	RLD	1995-12-20	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050686-001	CEDAX	EQ 90MG BASE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION / ORAL	RLD	1995-12-20	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050686-002	CEDAX	EQ 180MG BASE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION / ORAL	RLD	1995-12-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N050686-001	CEDAX	EQ 90MG BASE/5ML	FOR SUSPENSION / ORAL	RLD	1995-12-20	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N050686-002	CEDAX	EQ 180MG BASE/5ML	FOR SUSPENSION / ORAL	RLD	1995-12-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N050686-001	CEDAX	EQ 90MG BASE/5ML	FOR SUSPENSION / ORAL	RLD	1995-12-20	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N050686-002	CEDAX	EQ 180MG BASE/5ML	FOR SUSPENSION / ORAL	RLD	1995-12-20	`4b0b4de00fa7…`

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 · 1 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
59630-821	Cedax	Ceftibuten dihydrate	Sciele Pharma, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
30277	SUPPL	2011-03-16
39113	SUPPL	2011-03-14
8004	SUPPL	2010-11-08
39112	SUPPL	2009-02-12
8003	SUPPL	2009-02-12