Application 065501

Type: ANDA
Sponsor: GLAND PHARMA LTD

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
A065501-001	AZITHROMYCIN	AZITHROMYCIN	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP		2009-11-09

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A065501-001	AP

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	A065501-001	AZITHROMYCIN	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2009-11-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065501-001	AZITHROMYCIN	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2009-11-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065501-001	AZITHROMYCIN	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2009-11-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065501-001	AZITHROMYCIN	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2009-11-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065501-001	AZITHROMYCIN	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2009-11-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065501-001	AZITHROMYCIN	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2009-11-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065501-001	AZITHROMYCIN	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2009-11-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065501-001	AZITHROMYCIN	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2009-11-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065501-001	AZITHROMYCIN	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2009-11-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065501-001	AZITHROMYCIN	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2009-11-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065501-001	AZITHROMYCIN	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2009-11-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065501-001	AZITHROMYCIN	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2009-11-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065501-001	AZITHROMYCIN	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2009-11-09	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065501-001	AZITHROMYCIN	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2009-11-09	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065501-001	AZITHROMYCIN	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2009-11-09	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065501-001	AZITHROMYCIN	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2009-11-09	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065501-001	AZITHROMYCIN	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2009-11-09	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065501-001	AZITHROMYCIN	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2009-11-09	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065501-001	AZITHROMYCIN	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2009-11-09	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065501-001	AZITHROMYCIN	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2009-11-09	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065501-001	AZITHROMYCIN	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2009-11-09	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A065501-001	AZITHROMYCIN	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2009-11-09	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A065501-001	AZITHROMYCIN	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2009-11-09	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A065501-001	AZITHROMYCIN	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2009-11-09	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A065501-001	AZITHROMYCIN	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2009-11-09	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A065501-001	AZITHROMYCIN	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2009-11-09	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A065501-001	AZITHROMYCIN	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2009-11-09	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A065501-001	AZITHROMYCIN	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2009-11-09	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A065501-001	AZITHROMYCIN	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2009-11-09	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A065501-001	AZITHROMYCIN	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2009-11-09	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A065501-001	AZITHROMYCIN	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2009-11-09	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A065501-001	AZITHROMYCIN	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2009-11-09	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A065501-001	AZITHROMYCIN	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2009-11-09	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A065501-001	AZITHROMYCIN	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2009-11-09	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A065501-001	AZITHROMYCIN	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2009-11-09	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A065501-001	AZITHROMYCIN	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2009-11-09	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A065501-001	AZITHROMYCIN	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2009-11-09	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A065501-001	AZITHROMYCIN	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2009-11-09	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A065501-001	AZITHROMYCIN	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2009-11-09	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A065501-001	AZITHROMYCIN	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2009-11-09	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A065501-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065501-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065501-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065501-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065501-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065501-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065501-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065501-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065501-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065501-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065501-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065501-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065501-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065501-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065501-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065501-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065501-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065501-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065501-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065501-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065501-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A065501-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A065501-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A065501-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A065501-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A065501-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A065501-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A065501-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A065501-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A065501-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A065501-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A065501-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A065501-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A065501-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A065501-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A065501-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A065501-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A065501-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A065501-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A065501-001	AP	1	`cb3db0bc1861…`

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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Azithromycin	AZITHROMYCIN MONOHYDRATE	Sagent Pharmaceuticals	cefbce3f-3e6c-4659-abd7-3ec3e8227737	2025-07-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065501 application number: ANDA065501
Azithromycin	AZITHROMYCIN MONOHYDRATE	Athenex Pharmaceutical Division, LLC.	610a34ea-6aa7-4b94-a85a-ff16ca537d03	2025-01-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065501 application number: ANDA065501 ndc (product): 70860-125
Azithromycin	AZITHROMYCIN MONOHYDRATE	Athenex Pharmaceutical Division, LLC.	324330c5-20fe-4b22-adf2-14a6e91e71ef	2025-01-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065501 application number: ANDA065501 ndc (product): 70860-100
Azithromycin	AZITHROMYCIN MONOHYDRATE	Sagent Pharmaceuticals	6497fb5e-82d8-4411-b994-7ee01333ffd7	2024-09-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065501 application number: ANDA065501
Azithromycin monohydrate	AZITHROMYCIN MONOHYDRATE	Sun Pharmaceutical Industries Limited	c8d012c4-f411-4484-a618-7597599ea621	2023-06-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065501 application number: ANDA065501
Azithromycin monohydrate	AZITHROMYCIN MONOHYDRATE	Gland Pharma Limited	55051e03-b6dc-4bc6-87c1-e4fb84b61fa3	2022-12-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065501 application number: ANDA065501 ndc (product): 68083-199

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 13 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
60505-6076	Azithromycin	azithromycin for injection injection, powder, lyophilized, for solution	APOTEX CORP.	ANDA	Current
60505-6076	Azithromycin	azithromycin for injection injection, powder, lyophilized, for solution	APOTEX CORP.	ANDA	Current
68083-199	Azithromycin monohydrate	Azithromycin monohydrate	Gland Pharma Limited	ANDA	Current
68083-199	Azithromycin monohydrate	Azithromycin monohydrate	Gland Pharma Limited	ANDA	Current
68083-199	Azithromycin monohydrate	Azithromycin monohydrate	Gland Pharma Limited	ANDA	Current
70860-100	Azithromycin	azithromycin monohydrate	Athenex Pharmaceutical Division, LLC.	ANDA	Current
70860-100	Azithromycin	azithromycin monohydrate	Athenex Pharmaceutical Division, LLC.	ANDA	Current
70860-100	Azithromycin	azithromycin monohydrate	Athenex Pharmaceutical Division, LLC.	ANDA	Current
70860-100	Azithromycin	azithromycin monohydrate	Athenex Pharmaceutical Division, LLC.	ANDA	Current
70860-100	Azithromycin	azithromycin monohydrate	Athenex Pharmaceutical Division, LLC.	ANDA	Current
70860-125	Azithromycin	azithromycin monohydrate	Athenex Pharmaceutical Division, LLC.	ANDA	Current
70860-125	Azithromycin	azithromycin monohydrate	Athenex Pharmaceutical Division, LLC.	ANDA	Current
70860-125	Azithromycin	azithromycin monohydrate	Athenex Pharmaceutical Division, LLC.	ANDA	Current