Application 065509

Type: ANDA
Sponsor: APOTEX CORP

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	AZITHROMYCIN	AZITHROMYCIN	TABLET;ORAL	EQ 500MG BASE	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A065509-001	AZITHROMYCIN	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL			2011-07-13

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 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A065509-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	2011-07-13	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A065509-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	2011-07-13	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A065509-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	2011-07-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065509-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	2011-07-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065509-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	2011-07-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065509-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	2011-07-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065509-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	2011-07-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065509-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	2011-07-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065509-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	2011-07-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065509-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	2011-07-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065509-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	2011-07-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065509-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	2011-07-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065509-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	2011-07-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065509-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	2011-07-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065509-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	2011-07-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065509-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	2011-07-13	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065509-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	2011-07-13	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065509-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	2011-07-13	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065509-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	2011-07-13	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065509-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	2011-07-13	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065509-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	2011-07-13	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065509-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	2011-07-13	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065509-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	2011-07-13	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A065509-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	2011-07-13	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A065509-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	2011-07-13	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A065509-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	2011-07-13	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A065509-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	2011-07-13	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A065509-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	2011-07-13	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A065509-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	2011-07-13	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A065509-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	2011-07-13	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A065509-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	2011-07-13	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A065509-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	2011-07-13	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A065509-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	2011-07-13	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A065509-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	2011-07-13	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A065509-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	2011-07-13	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A065509-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	2011-07-13	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A065509-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	2011-07-13	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A065509-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	2011-07-13	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A065509-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	2011-07-13	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A065509-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	2011-07-13	`f41ea6bd6efb…`

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.	94e17ae5-0871-67a0-e053-2995a90ae0ae	2026-09-09	Warnings, Adverse reactions	Name fallback brand name: Azithromycin generic name: AZITHROMYCIN
azithromycin	AZITHROMYCIN	REMEDYREPACK INC.	da399401-1ee6-422a-be46-0bba6b264b2f	2026-09-08	Warnings, Adverse reactions	Name fallback brand name: azithromycin generic name: AZITHROMYCIN
Azithromycin	AZITHROMYCIN	Aurobindo Pharma Limited	3c902990-b870-4725-b9fe-76b8be633e1c	2026-09-03	Warnings, Adverse reactions	Name fallback brand name: Azithromycin generic name: AZITHROMYCIN
azithromycin	AZITHROMYCIN	Major Pharmaceuticals	814abe38-da4a-48af-bf4b-2ce04a5aabd1	2026-09-02	Warnings, Adverse reactions	Name fallback brand name: azithromycin generic name: AZITHROMYCIN
azithromycin	AZITHROMYCIN	REMEDYREPACK INC.	bf061799-cdef-40f8-b1ce-bc5eb609f8c3	2026-09-02	Warnings, Adverse reactions	Name fallback brand name: azithromycin generic name: AZITHROMYCIN
Azithromycin	AZITHROMYCIN	Aurobindo Pharma Limited	795c13cd-e9ca-481b-9fa9-2890bdf9dac8	2026-09-02	Warnings, Adverse reactions	Name fallback brand name: Azithromycin generic name: AZITHROMYCIN
azithromycin	AZITHROMYCIN	Lupin Pharmaceuticals, Inc.	01649d79-4677-4577-a3e4-e054f3f9fc3b	2026-08-20	Warnings, Adverse reactions	Name fallback brand name: azithromycin generic name: AZITHROMYCIN
azithromycin	AZITHROMYCIN	Lupin Pharmaceuticals, Inc.	c9990a1d-5238-403e-9221-72a9314d7b5e	2026-08-20	Warnings, Adverse reactions	Name fallback brand name: azithromycin generic name: AZITHROMYCIN
Azithromycin	AZITHROMYCIN	Zydus Pharmaceuticals USA Inc.	99e5bd22-a721-4e2e-a46c-d61a53c25c3d	2026-08-14	Warnings, Adverse reactions	Name fallback brand name: Azithromycin generic name: AZITHROMYCIN
Azithromycin	AZITHROMYCIN	REMEDYREPACK INC.	614cc2a4-3fc7-455d-9e8a-212c496f0fbf	2026-08-05	Warnings, Adverse reactions	Name fallback brand name: Azithromycin generic name: AZITHROMYCIN
Azithromycin	AZITHROMYCIN	Sandoz Inc	34b70c23-92a6-460f-8dbb-15a0e6b9d3a9	2026-07-30	Warnings, Adverse reactions	Name fallback brand name: Azithromycin generic name: AZITHROMYCIN
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	Sandoz Inc	ec619299-e0ef-44dd-acdb-8c53bbfc5b8a	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	Eugia US LLC	7b81436e-d14a-4353-a22d-253f45e2e576	2026-07-27	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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 7 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50090-1655	Azithromycin Dihydrate	azithromycin	A-S Medication Solutions	ANDA	Current
50268-104	Azithromycin Dihydrate	azithromycin	AvPAK	ANDA	Current
50436-2852	Azithromycin Dihydrate	azithromycin	Unit Dose Services	ANDA	Current
53002-2221	Azithromycin Dihydrate	azithromycin	RPK Pharmaceuticals, Inc.	ANDA	Current
68788-9521	Azithromycin Dihydrate	azithromycin	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-9521	Azithromycin Dihydrate	azithromycin	Preferred Pharmaceuticals, Inc.	ANDA	Current
70882-118	Azithromycin Dihydrate	azithromycin	Cambridge Therapeutics Technologies, LLC	ANDA	Current