Home Applications 050814 Application 050814
Type NDA
Sponsor GILEAD Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 CAYSTON AZTREONAM FOR SOLUTION;INHALATION 75MG/VIAL Yes Yes
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 N050814-001 CAYSTON AZTREONAM 75MG/VIAL FOR SOLUTION / INHALATION RLD, RS 2010-02-22
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 N050814-001 CAYSTON 75MG/VIAL FOR SOLUTION / INHALATION RLD, RS 2010-02-22 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N050814-001 CAYSTON 75MG/VIAL FOR SOLUTION / INHALATION RLD, RS 2010-02-22 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N050814-001 CAYSTON 75MG/VIAL FOR SOLUTION / INHALATION RLD, RS 2010-02-22 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N050814-001 CAYSTON 75MG/VIAL FOR SOLUTION / INHALATION RLD, RS 2010-02-22 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 N050814-001 7208141 2021-12-20 U-1031 Drug product 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N050814-001 7214364 2021-12-20 Drug product 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N050814-001 7427633 2021-12-20 U-1031 Drug product 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N050814-001 8399496 2021-12-20 U-1377 Drug product 2013-04-19 74a2ff9319b5…2021-12-28 21:50 UTC 2021-12 N050814-001 7208141 2021-12-20 U-1031 Drug product 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N050814-001 7214364 2021-12-20 Drug product 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N050814-001 7427633 2021-12-20 U-1031 Drug product 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N050814-001 8399496 2021-12-20 U-1377 Drug product 2013-04-19 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N050814-001 7208141 2021-12-20 U-1031 Drug product 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N050814-001 7214364 2021-12-20 Drug product 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N050814-001 7427633 2021-12-20 U-1031 Drug product 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N050814-001 8399496 2021-12-20 U-1377 Drug product 2013-04-19 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N050814-001 7208141 2021-12-20 U-1031 Drug product 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N050814-001 7214364 2021-12-20 Drug product 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N050814-001 7427633 2021-12-20 U-1031 Drug product 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N050814-001 8399496 2021-12-20 U-1377 Drug product 2013-04-19 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N050814-001 7208141 2021-12-20 U-1031 Drug product 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N050814-001 7214364 2021-12-20 Drug product 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N050814-001 7427633 2021-12-20 U-1031 Drug product 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N050814-001 8399496 2021-12-20 U-1377 Drug product 2013-04-19 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N050814-001 7208141 2021-12-20 U-1031 Drug product c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N050814-001 7214364 2021-12-20 Drug product c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N050814-001 7427633 2021-12-20 U-1031 Drug product c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N050814-001 8399496 2021-12-20 U-1377 Drug product 2013-04-19 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N050814-001 7208141 2021-12-20 U-1031 Drug product 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N050814-001 7214364 2021-12-20 Drug product 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N050814-001 7427633 2021-12-20 U-1031 Drug product 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N050814-001 8399496 2021-12-20 U-1377 Drug product 2013-04-19 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N050814-001 7208141 2021-12-20 U-1031 Drug product b00525d2431f…2019-09-15 20:21 UTC 2019-09 N050814-001 7214364 2021-12-20 Drug product b00525d2431f…2019-09-15 20:21 UTC 2019-09 N050814-001 7427633 2021-12-20 U-1031 Drug product b00525d2431f…2019-09-15 20:21 UTC 2019-09 N050814-001 8399496 2021-12-20 U-1377 Drug product 2013-04-19 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N050814-001 7208141 2021-12-20 U-1031 Drug product ea99ee380514…2019-07-19 19:46 UTC 2019-07 N050814-001 7214364 2021-12-20 Drug product ea99ee380514…2019-07-19 19:46 UTC 2019-07 N050814-001 7427633 2021-12-20 U-1031 Drug product ea99ee380514…2019-07-19 19:46 UTC 2019-07 N050814-001 8399496 2021-12-20 U-1377 Drug product 2013-04-19 ea99ee380514…
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
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 · 4 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 61958-0901 Cayston aztreonam Gilead Sciences, Inc. NDA Current 61958-0901 Cayston aztreonam Gilead Sciences, Inc. NDA Current 61958-0901 Cayston aztreonam Gilead Sciences, Inc. NDA Current 61958-0901 Cayston aztreonam Gilead Sciences, Inc. NDA Current
Documents# Document, Submission type, Date table Document Submission type Date 61012 SUPPL 2019-11-21 61007 SUPPL 2019-11-21 57610 SUPPL 2019-02-14 57504 SUPPL 2019-02-12 8336 SUPPL 2015-12-30 30604 SUPPL 2012-09-26 39382 SUPPL 2012-09-25 22251 SUPPL 2011-12-09 44788 ORIG 2011-03-04 22250 ORIG 2011-03-04 8335 SUPPL 2010-08-25 39381 ORIG 2010-03-03 30603 ORIG 2010-02-26