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 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
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 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N050814-001	CAYSTON	75MG/VIAL	FOR SOLUTION / INHALATION	RLD, RS	2010-02-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050814-001	CAYSTON	75MG/VIAL	FOR SOLUTION / INHALATION	RLD, RS	2010-02-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N050814-001	CAYSTON	75MG/VIAL	FOR SOLUTION / INHALATION	RLD, RS	2010-02-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050814-001	CAYSTON	75MG/VIAL	FOR SOLUTION / INHALATION	RLD, RS	2010-02-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050814-001	CAYSTON	75MG/VIAL	FOR SOLUTION / INHALATION	RLD, RS	2010-02-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050814-001	CAYSTON	75MG/VIAL	FOR SOLUTION / INHALATION	RLD, RS	2010-02-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050814-001	CAYSTON	75MG/VIAL	FOR SOLUTION / INHALATION	RLD, RS	2010-02-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050814-001	CAYSTON	75MG/VIAL	FOR SOLUTION / INHALATION	RLD, RS	2010-02-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050814-001	CAYSTON	75MG/VIAL	FOR SOLUTION / INHALATION	RLD, RS	2010-02-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N050814-001	CAYSTON	75MG/VIAL	FOR SOLUTION / INHALATION	RLD, RS	2010-02-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050814-001	CAYSTON	75MG/VIAL	FOR SOLUTION / INHALATION	RLD, RS	2010-02-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050814-001	CAYSTON	75MG/VIAL	FOR SOLUTION / INHALATION	RLD, RS	2010-02-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050814-001	CAYSTON	75MG/VIAL	FOR SOLUTION / INHALATION	RLD, RS	2010-02-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N050814-001	CAYSTON	75MG/VIAL	FOR SOLUTION / INHALATION	RLD, RS	2010-02-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050814-001	CAYSTON	75MG/VIAL	FOR SOLUTION / INHALATION	RLD, RS	2010-02-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N050814-001	CAYSTON	75MG/VIAL	FOR SOLUTION / INHALATION	RLD, RS	2010-02-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N050814-001	CAYSTON	75MG/VIAL	FOR SOLUTION / INHALATION	RLD, RS	2010-02-22	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N050814-001	CAYSTON	75MG/VIAL	FOR SOLUTION / INHALATION	RLD, RS	2010-02-22	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N050814-001	CAYSTON	75MG/VIAL	FOR SOLUTION / INHALATION	RLD, RS	2010-02-22	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N050814-001	CAYSTON	75MG/VIAL	FOR SOLUTION / INHALATION	RLD, RS	2010-02-22	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N050814-001	CAYSTON	75MG/VIAL	FOR SOLUTION / INHALATION	RLD, RS	2010-02-22	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N050814-001	CAYSTON	75MG/VIAL	FOR SOLUTION / INHALATION	RLD, RS	2010-02-22	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N050814-001	CAYSTON	75MG/VIAL	FOR SOLUTION / INHALATION	RLD, RS	2010-02-22	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N050814-001	CAYSTON	75MG/VIAL	FOR SOLUTION / INHALATION	RLD, RS	2010-02-22	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N050814-001	CAYSTON	75MG/VIAL	FOR SOLUTION / INHALATION	RLD, RS	2010-02-22	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N050814-001	CAYSTON	75MG/VIAL	FOR SOLUTION / INHALATION	RLD, RS	2010-02-22	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N050814-001	CAYSTON	75MG/VIAL	FOR SOLUTION / INHALATION	RLD, RS	2010-02-22	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N050814-001	CAYSTON	75MG/VIAL	FOR SOLUTION / INHALATION	RLD, RS	2010-02-22	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N050814-001	CAYSTON	75MG/VIAL	FOR SOLUTION / INHALATION	RLD, RS	2010-02-22	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N050814-001	CAYSTON	75MG/VIAL	FOR SOLUTION / INHALATION	RLD, RS	2010-02-22	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N050814-001	CAYSTON	75MG/VIAL	FOR SOLUTION / INHALATION	RLD, RS	2010-02-22	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N050814-001	CAYSTON	75MG/VIAL	FOR SOLUTION / INHALATION	RLD, RS	2010-02-22	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N050814-001	CAYSTON	75MG/VIAL	FOR SOLUTION / INHALATION	RLD, RS	2010-02-22	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N050814-001	CAYSTON	75MG/VIAL	FOR SOLUTION / INHALATION	RLD, RS	2010-02-22	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N050814-001	CAYSTON	75MG/VIAL	FOR SOLUTION / INHALATION	RLD, RS	2010-02-22	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N050814-001	CAYSTON	75MG/VIAL	FOR SOLUTION / INHALATION	RLD, RS	2010-02-22	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N050814-001	CAYSTON	75MG/VIAL	FOR SOLUTION / INHALATION	RLD, RS	2010-02-22	`3a93d1ddd44b…`
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…`

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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cayston	AZTREONAM	Gilead Sciences, Inc.	67300ca3-8c53-4ce4-8e86-2c03be1f9b8a	2025-12-01	Warnings, Adverse reactions	Exact identifier application applno (NDA): 050814 application number: NDA050814 ndc (product): 61958-0901

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