Application 021406

Type: NDA
Sponsor: UPSHER SMITH LABS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	FORTICAL	CALCITONIN SALMON RECOMBINANT	SPRAY, METERED;NASAL	200 IU/SPRAY Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
N021406-001	FORTICAL	CALCITONIN SALMON RECOMBINANT	200 IU/SPRAY Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY, METERED / NASAL			2005-08-12

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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-01 22:54:32	2026-06	N021406-001	FORTICAL	200 IU/SPRAY Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY, METERED / NASAL			2005-08-12	`a50c72e98297…`

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
0245-0008	Fortical	calcitonin salmon	Upsher-Smith Laboratories, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
36824	SUPPL	2014-07-11
27680	SUPPL	2014-07-10
5260	SUPPL	2014-07-10
27679	SUPPL	2011-08-17
15376	SUPPL	2011-08-16
27678	SUPPL	2009-06-26
15375	SUPPL	2009-06-24
21638	ORIG	2007-05-09
5259	SUPPL	2007-02-12
36823	SUPPL	2006-05-01
27677	SUPPL	2006-05-01
27676	ORIG	2005-08-19
15374	ORIG	2005-08-15