Application 065506

Type: ANDA
Sponsor: MYLAN ASI

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	AZITHROMYCIN	AZITHROMYCIN	INJECTABLE;INJECTION	EQ 500MG BASE/VIAL	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
A065506-001	AZITHROMYCIN	AZITHROMYCIN	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION			2009-03-24

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	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A065506-001	AZITHROMYCIN	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION		2009-03-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065506-001	AZITHROMYCIN	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION		2009-03-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065506-001	AZITHROMYCIN	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION		2009-03-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065506-001	AZITHROMYCIN	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION		2009-03-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065506-001	AZITHROMYCIN	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION		2009-03-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065506-001	AZITHROMYCIN	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION		2009-03-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065506-001	AZITHROMYCIN	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION		2009-03-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065506-001	AZITHROMYCIN	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION		2009-03-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065506-001	AZITHROMYCIN	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION		2009-03-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065506-001	AZITHROMYCIN	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION		2009-03-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065506-001	AZITHROMYCIN	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION		2009-03-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065506-001	AZITHROMYCIN	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION		2009-03-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065506-001	AZITHROMYCIN	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION		2009-03-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065506-001	AZITHROMYCIN	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION		2009-03-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065506-001	AZITHROMYCIN	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION		2009-03-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065506-001	AZITHROMYCIN	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION		2009-03-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065506-001	AZITHROMYCIN	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION		2009-03-24	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065506-001	AZITHROMYCIN	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2009-03-24	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065506-001	AZITHROMYCIN	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION		2009-03-24	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065506-001	AZITHROMYCIN	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION		2009-03-24	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065506-001	AZITHROMYCIN	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION		2009-03-24	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A065506-001	AZITHROMYCIN	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2009-03-24	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A065506-001	AZITHROMYCIN	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2009-03-24	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A065506-001	AZITHROMYCIN	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2009-03-24	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A065506-001	AZITHROMYCIN	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2009-03-24	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A065506-001	AZITHROMYCIN	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2009-03-24	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A065506-001	AZITHROMYCIN	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2009-03-24	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A065506-001	AZITHROMYCIN	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION		2009-03-24	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A065506-001	AZITHROMYCIN	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION		2009-03-24	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A065506-001	AZITHROMYCIN	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION		2009-03-24	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A065506-001	AZITHROMYCIN	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION		2009-03-24	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A065506-001	AZITHROMYCIN	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION		2009-03-24	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A065506-001	AZITHROMYCIN	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION		2009-03-24	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A065506-001	AZITHROMYCIN	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION		2009-03-24	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A065506-001	AZITHROMYCIN	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION		2009-03-24	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A065506-001	AZITHROMYCIN	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION		2009-03-24	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A065506-001	AZITHROMYCIN	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION		2009-03-24	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A065506-001	AZITHROMYCIN	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION		2009-03-24	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A065506-001	AZITHROMYCIN	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION		2009-03-24	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A065506-001	AZITHROMYCIN	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION		2009-03-24	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A065506-001	AP	1	`74a2ff9319b5…`
2021-03-12 10:30 UTC	2021-03	A065506-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A065506-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A065506-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A065506-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A065506-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A065506-001	AP	1	`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 6 · 111 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Azithromycin	AZITHROMYCIN	NuCare Pharmaceuticals,Inc.	a9cdb5ae-2aeb-c598-e053-2a95a90a8062	2026-07-30	Warnings, Adverse reactions	Name fallback brand name: Azithromycin generic name: AZITHROMYCIN
Azithromycin	AZITHROMYCIN	A-S Medication Solutions	882f71b1-b153-4856-b4a7-1a29ae9cf247	2026-07-29	Warnings, Adverse reactions	Name fallback brand name: Azithromycin generic name: AZITHROMYCIN
Azithromycin	AZITHROMYCIN	REMEDYREPACK INC.	5f144e92-c9eb-420a-9bb8-4265a9f20a98	2026-07-24	Warnings, Adverse reactions	Name fallback brand name: Azithromycin generic name: AZITHROMYCIN
Azithromycin	AZITHROMYCIN	A-S Medication Solutions	3b7e16b1-9a3c-4e3a-8411-841a708afe45	2026-07-23	Warnings, Adverse reactions	Name fallback brand name: Azithromycin generic name: AZITHROMYCIN
Azithromycin	AZITHROMYCIN	A-S Medication Solutions	58308e8b-57bd-4e82-a2e8-24aac63194cd	2026-07-23	Warnings, Adverse reactions	Name fallback brand name: Azithromycin generic name: AZITHROMYCIN
Azithromycin	AZITHROMYCIN	Bryant Ranch Prepack	2a8010dc-700f-45d3-94ca-ebe4a51acc1b	2026-07-20	Warnings, Adverse reactions	Name fallback brand name: Azithromycin generic name: AZITHROMYCIN
Azithromycin	AZITHROMYCIN	Bryant Ranch Prepack	6caeda98-7020-413a-9461-04f476dad4ba	2026-07-20	Warnings, Adverse reactions	Name fallback brand name: Azithromycin generic name: AZITHROMYCIN
Azithromycin	AZITHROMYCIN	A-S Medication Solutions	3c4861f2-825e-4e3b-9907-9658a849079e	2026-07-16	Warnings, Adverse reactions	Name fallback brand name: Azithromycin generic name: AZITHROMYCIN
Azithromycin	AZITHROMYCIN	REMEDYREPACK INC.	333ffe63-aaeb-4dff-b595-1c11209189a6	2026-07-01	Warnings, Adverse reactions	Name fallback brand name: Azithromycin generic name: AZITHROMYCIN
AZITHROMYCIN	AZITHROMYCIN	A-S Medication Solutions	76093152-e2d7-4fe1-8568-1f0fec1747c2	2026-07-01	Warnings, Adverse reactions	Name fallback brand name: AZITHROMYCIN generic name: AZITHROMYCIN
Azithromycin	AZITHROMYCIN	REMEDYREPACK INC.	943b9246-7733-44b1-875c-91d2ade78ac4	2026-06-29	Warnings, Adverse reactions	Name fallback brand name: Azithromycin generic name: AZITHROMYCIN
Azithromycin	AZITHROMYCIN	Preferred Pharmaceuticals Inc.	661ff7a6-6394-493d-a307-a1f607e5d117	2026-06-16	Warnings, Adverse reactions	Name fallback brand name: Azithromycin generic name: AZITHROMYCIN
Azithromycin	AZITHROMYCIN	Bryant Ranch Prepack	b5d79719-b1dc-469f-a19c-f8ba615138f0	2026-05-14	Warnings, Adverse reactions	Name fallback brand name: Azithromycin generic name: AZITHROMYCIN
Azithromycin	AZITHROMYCIN	REMEDYREPACK INC.	614cc2a4-3fc7-455d-9e8a-212c496f0fbf	2026-05-12	Warnings, Adverse reactions	Name fallback brand name: Azithromycin generic name: AZITHROMYCIN
azithromycin	AZITHROMYCIN	Coupler LLC	510024c9-6658-e08f-e063-6294a90a0793	2026-05-04	Warnings, Adverse reactions	Name fallback brand name: azithromycin generic name: AZITHROMYCIN
Azithromycin	AZITHROMYCIN	Sportpharm LLC	397471e5-76e2-462c-af30-bcc54fe00266	2026-04-24	Warnings, Adverse reactions	Name fallback brand name: Azithromycin generic name: AZITHROMYCIN
Azithromycin	AZITHROMYCIN	Aurobindo Pharma Limited	795c13cd-e9ca-481b-9fa9-2890bdf9dac8	2026-04-16	Warnings, Adverse reactions	Name fallback brand name: Azithromycin generic name: AZITHROMYCIN
azithromycin	AZITHROMYCIN	Cardinal Health 107, LLC	ea128124-8712-4998-be46-47d43ef127d4	2026-04-10	Warnings, Adverse reactions	Name fallback brand name: azithromycin generic name: AZITHROMYCIN
Azithromycin	AZITHROMYCIN	Bryant Ranch Prepack	a81212ef-76b6-4bd7-8706-3d2b05ee34f9	2026-03-30	Warnings, Adverse reactions	Name fallback brand name: Azithromycin generic name: AZITHROMYCIN
Azithromycin	AZITHROMYCIN	A-S Medication Solutions	24c07398-84ad-48e2-9625-e9073c28fb73	2026-03-24	Warnings, Adverse reactions	Name fallback brand name: Azithromycin generic name: AZITHROMYCIN

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
25021-112	Azithromycin	azithromycin	Sagent Pharmaceuticals	ANDA	Current
67457-860	Azithromycin	azithromycin	Mylan Institutional LLC	ANDA	Current
67457-860	Azithromycin	azithromycin	Mylan Institutional LLC	ANDA	Current
67457-860	Azithromycin	azithromycin	Mylan Institutional LLC	ANDA	Current