Application 050634

Type: NDA
Sponsor: TELIGENT

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	FORTAZ IN PLASTIC CONTAINER	CEFTAZIDIME SODIUM	INJECTABLE;INJECTION	EQ 10MG BASE/ML	No	No
002	FORTAZ IN PLASTIC CONTAINER	CEFTAZIDIME SODIUM	INJECTABLE;INJECTION	EQ 20MG BASE/ML	Yes	No
003	FORTAZ IN PLASTIC CONTAINER	CEFTAZIDIME SODIUM	INJECTABLE;INJECTION	EQ 40MG BASE/ML	Yes	No

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N050634-001	FORTAZ IN PLASTIC CONTAINER	CEFTAZIDIME SODIUM	EQ 10MG BASE/ML	INJECTABLE / INJECTION		1989-04-28
N050634-002	FORTAZ IN PLASTIC CONTAINER	CEFTAZIDIME SODIUM	EQ 20MG BASE/ML	INJECTABLE / INJECTION	RLD	1989-04-28
N050634-003	FORTAZ IN PLASTIC CONTAINER	CEFTAZIDIME SODIUM	EQ 40MG BASE/ML	INJECTABLE / INJECTION	RLD	1989-04-28

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 4 of 4 · 132 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2022-10-28 04:53 UTC	2022-10	N050634-001	FORTAZ IN PLASTIC CONTAINER	EQ 10MG BASE/ML	INJECTABLE / INJECTION		1989-04-28	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N050634-002	FORTAZ IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	RLD	1989-04-28	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N050634-003	FORTAZ IN PLASTIC CONTAINER	EQ 40MG BASE/ML	INJECTABLE / INJECTION	RLD	1989-04-28	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N050634-001	FORTAZ IN PLASTIC CONTAINER	EQ 10MG BASE/ML	INJECTABLE / INJECTION		1989-04-28	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	N050634-002	FORTAZ IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	RLD	1989-04-28	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	N050634-003	FORTAZ IN PLASTIC CONTAINER	EQ 40MG BASE/ML	INJECTABLE / INJECTION	RLD	1989-04-28	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N050634-001	FORTAZ IN PLASTIC CONTAINER	EQ 10MG BASE/ML	INJECTABLE / INJECTION		1989-04-28	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N050634-002	FORTAZ IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	RLD	1989-04-28	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N050634-003	FORTAZ IN PLASTIC CONTAINER	EQ 40MG BASE/ML	INJECTABLE / INJECTION	RLD	1989-04-28	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N050634-001	FORTAZ IN PLASTIC CONTAINER	EQ 10MG BASE/ML	INJECTABLE / INJECTION		1989-04-28	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N050634-002	FORTAZ IN PLASTIC CONTAINER	EQ 20MG BASE/ML	INJECTABLE / INJECTION	RLD	1989-04-28	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N050634-003	FORTAZ IN PLASTIC CONTAINER	EQ 40MG BASE/ML	INJECTABLE / INJECTION	RLD	1989-04-28	`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 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
52565-112	FORTAZ	ceftazidime sodium	Teligent Pharma, Inc.	NDA	Current
52565-113	FORTAZ	ceftazidime sodium	Teligent Pharma, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
49191	SUPPL	2017-08-02
49160	SUPPL	2017-07-31
39061	SUPPL	2014-09-26
30201	SUPPL	2014-09-26
30200	SUPPL	2007-07-16
39060	SUPPL	2007-07-10
39059	SUPPL	2007-03-15
30199	SUPPL	2007-03-15
39058	SUPPL	2004-05-27
7913	SUPPL	2004-05-26
30197	SUPPL	2002-03-29
17957	SUPPL	2002-03-29
30198	SUPPL	2002-03-22