Application 065286

Type: ANDA
Sponsor: WEST-WARD PHARMS INT

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	AZTREONAM	AZTREONAM	INJECTABLE;INJECTION	1GM/VIAL	No	No
002	AZTREONAM	AZTREONAM	INJECTABLE;INJECTION	2GM/VIAL	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A065286-001	AZTREONAM	AZTREONAM	1GM/VIAL	INJECTABLE / INJECTION			2011-03-23
A065286-002	AZTREONAM	AZTREONAM	2GM/VIAL	INJECTABLE / INJECTION			2011-03-23

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 3 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A065286-001	AZTREONAM	1GM/VIAL	INJECTABLE / INJECTION	2011-03-23	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A065286-002	AZTREONAM	2GM/VIAL	INJECTABLE / INJECTION	2011-03-23	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065286-001	AZTREONAM	1GM/VIAL	INJECTABLE / INJECTION	2011-03-23	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A065286-002	AZTREONAM	2GM/VIAL	INJECTABLE / INJECTION	2011-03-23	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065286-001	AZTREONAM	1GM/VIAL	INJECTABLE / INJECTION	2011-03-23	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A065286-002	AZTREONAM	2GM/VIAL	INJECTABLE / INJECTION	2011-03-23	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065286-001	AZTREONAM	1GM/VIAL	INJECTABLE / INJECTION	2011-03-23	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065286-002	AZTREONAM	2GM/VIAL	INJECTABLE / INJECTION	2011-03-23	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A065286-001	AZTREONAM	1GM/VIAL	INJECTABLE / INJECTION	2011-03-23	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A065286-002	AZTREONAM	2GM/VIAL	INJECTABLE / INJECTION	2011-03-23	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A065286-001	AZTREONAM	1GM/VIAL	INJECTABLE / INJECTION	2011-03-23	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A065286-002	AZTREONAM	2GM/VIAL	INJECTABLE / INJECTION	2011-03-23	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A065286-001	AZTREONAM	1GM/VIAL	INJECTABLE / INJECTION	2011-03-23	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A065286-002	AZTREONAM	2GM/VIAL	INJECTABLE / INJECTION	2011-03-23	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A065286-001	AZTREONAM	1GM/VIAL	INJECTABLE / INJECTION	2011-03-23	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A065286-002	AZTREONAM	2GM/VIAL	INJECTABLE / INJECTION	2011-03-23	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A065286-001	AZTREONAM	1GM/VIAL	INJECTABLE / INJECTION	2011-03-23	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A065286-002	AZTREONAM	2GM/VIAL	INJECTABLE / INJECTION	2011-03-23	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A065286-001	AZTREONAM	1GM/VIAL	INJECTABLE / INJECTION	2011-03-23	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A065286-002	AZTREONAM	2GM/VIAL	INJECTABLE / INJECTION	2011-03-23	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A065286-001	AZTREONAM	1GM/VIAL	INJECTABLE / INJECTION	2011-03-23	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A065286-002	AZTREONAM	2GM/VIAL	INJECTABLE / INJECTION	2011-03-23	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A065286-001	AZTREONAM	1GM/VIAL	INJECTABLE / INJECTION	2011-03-23	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A065286-002	AZTREONAM	2GM/VIAL	INJECTABLE / INJECTION	2011-03-23	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A065286-001	AZTREONAM	1GM/VIAL	INJECTABLE / INJECTION	2011-03-23	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A065286-002	AZTREONAM	2GM/VIAL	INJECTABLE / INJECTION	2011-03-23	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A065286-001	AZTREONAM	1GM/VIAL	INJECTABLE / INJECTION	2011-03-23	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A065286-002	AZTREONAM	2GM/VIAL	INJECTABLE / INJECTION	2011-03-23	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A065286-001	AZTREONAM	1GM/VIAL	INJECTABLE / INJECTION	2011-03-23	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A065286-002	AZTREONAM	2GM/VIAL	INJECTABLE / INJECTION	2011-03-23	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A065286-001	AZTREONAM	1GM/VIAL	INJECTABLE / INJECTION	2011-03-23	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A065286-002	AZTREONAM	2GM/VIAL	INJECTABLE / INJECTION	2011-03-23	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A065286-001	AZTREONAM	1GM/VIAL	INJECTABLE / INJECTION	2011-03-23	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A065286-002	AZTREONAM	2GM/VIAL	INJECTABLE / INJECTION	2011-03-23	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A065286-001	AZTREONAM	1GM/VIAL	INJECTABLE / INJECTION	2011-03-23	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A065286-002	AZTREONAM	2GM/VIAL	INJECTABLE / INJECTION	2011-03-23	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A065286-001	AZTREONAM	1GM/VIAL	INJECTABLE / INJECTION	2011-03-23	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A065286-002	AZTREONAM	2GM/VIAL	INJECTABLE / INJECTION	2011-03-23	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A065286-001	AZTREONAM	1GM/VIAL	INJECTABLE / INJECTION	2011-03-23	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A065286-002	AZTREONAM	2GM/VIAL	INJECTABLE / INJECTION	2011-03-23	`3a93d1ddd44b…`

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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
AZACTAM	AZTREONAM	E.R. Squibb & Sons, L.L.C.	9a105eaf-ee77-4016-beeb-d425a5565db2	2025-12-15	Warnings, Adverse reactions	Name fallback generic name: AZTREONAM
Cayston	AZTREONAM	Gilead Sciences, Inc.	67300ca3-8c53-4ce4-8e86-2c03be1f9b8a	2025-12-01	Warnings, Adverse reactions	Name fallback generic name: AZTREONAM
AZACTAM	AZTREONAM	A-S Medication Solutions	f9d5515e-54bc-4efc-9f49-8ee3e88c3e01	2025-01-09	Warnings, Adverse reactions	Name fallback generic name: AZTREONAM
Aztreonam	AZTREONAM	Hospira, Inc.	d4500795-3b07-4a7d-b432-73cafbb3dbc6	2024-06-03	Warnings, Adverse reactions	Name fallback brand name: Aztreonam generic name: AZTREONAM
Aztreonam	AZTREONAM	Fresenius Kabi USA, LLC	5f5ebb63-6ac5-4fb4-bcc1-d069c123eb18	2022-05-06	Warnings, Adverse reactions	Name fallback brand name: Aztreonam generic name: AZTREONAM
Aztreonam	AZTREONAM	Fresenius Kabi USA, LLC	302fd27d-0a22-44ea-91fb-1b1ffcf17a1f	2022-04-30	Warnings, Adverse reactions	Name fallback brand name: Aztreonam generic name: AZTREONAM
Aztreonam	AZTREONAM	Fresenius Kabi USA, LLC	c6cf7e13-a04e-47e2-9cec-44a278ee6bec	2022-03-29	Warnings, Adverse reactions	Name fallback brand name: Aztreonam generic name: AZTREONAM

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

Document, Submission type, Date table
Document	Submission type	Date
42815	ORIG	2016-07-29