Home Applications 021406 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RECOMBINANT SPRAY, METERED;NASAL 200 IU/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** No No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 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 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CALCITONIN SALMON RECOMBINANT 200 IU/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SPRAY, METERED / NASAL 2005-08-12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.
Product history page 2 of 2 · 44 observed 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 2022-10-28 04:53 UTC 2022-10 N021406-001 FORTICAL 200 IU/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SPRAY, METERED / NASAL 2005-08-12 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N021406-001 FORTICAL 200 IU/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SPRAY, METERED / NASAL 2005-08-12 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N021406-001 FORTICAL 200 IU/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SPRAY, METERED / NASAL 2005-08-12 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N021406-001 FORTICAL 200 IU/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SPRAY, METERED / NASAL 2005-08-12 a50c72e98297…
Observed Orange Book patent history# Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2019-12-13 00:20 UTC 2019-12 N021406-001 6440392 2021-02-02 U-227 Drug product 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021406-001 RE40812 2021-02-02 Drug product 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021406-001 RE43580 2021-02-02 U-227 Drug product 2013-04-26 74a2ff9319b5…2021-12-28 21:50 UTC 2021-12 N021406-001 6440392 2021-02-02 U-227 Drug product 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N021406-001 RE40812 2021-02-02 Drug product 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N021406-001 RE43580 2021-02-02 U-227 Drug product 2013-04-26 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021406-001 6440392 2021-02-02 U-227 Drug product 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021406-001 RE40812 2021-02-02 Drug product 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021406-001 RE43580 2021-02-02 U-227 Drug product 2013-04-26 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N021406-001 6440392 2021-02-02 U-227 Drug product 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N021406-001 RE40812 2021-02-02 Drug product 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N021406-001 RE43580 2021-02-02 U-227 Drug product 2013-04-26 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N021406-001 6440392 2021-02-02 U-227 Drug product 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N021406-001 RE40812 2021-02-02 Drug product 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N021406-001 RE43580 2021-02-02 U-227 Drug product 2013-04-26 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N021406-001 6440392 2021-02-02 U-227 Drug product c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N021406-001 RE40812 2021-02-02 Drug product c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N021406-001 RE43580 2021-02-02 U-227 Drug product 2013-04-26 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N021406-001 6440392 2021-02-02 U-227 Drug product 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N021406-001 RE40812 2021-02-02 Drug product 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N021406-001 RE43580 2021-02-02 U-227 Drug product 2013-04-26 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N021406-001 6440392 2021-02-02 U-227 Drug product b00525d2431f…2019-09-15 20:21 UTC 2019-09 N021406-001 RE40812 2021-02-02 Drug product b00525d2431f…2019-09-15 20:21 UTC 2019-09 N021406-001 RE43580 2021-02-02 U-227 Drug product 2013-04-26 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N021406-001 6440392 2021-02-02 U-227 Drug product ea99ee380514…2019-07-19 19:46 UTC 2019-07 N021406-001 RE40812 2021-02-02 Drug product ea99ee380514…2019-07-19 19:46 UTC 2019-07 N021406-001 RE43580 2021-02-02 U-227 Drug product 2013-04-26 ea99ee380514…
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 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