Application 207398

Type: ANDA
Sponsor: AUROBINDO PHARMA LTD

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 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
A207398-001	AZITHROMYCIN	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB		2018-07-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A207398-001	AB

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	A207398-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2018-07-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207398-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2018-07-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207398-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2018-07-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207398-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2018-07-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207398-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2018-07-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207398-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2018-07-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207398-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2018-07-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207398-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2018-07-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207398-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2018-07-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207398-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2018-07-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207398-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2018-07-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207398-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2018-07-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207398-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2018-07-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207398-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2018-07-05	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207398-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2018-07-05	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207398-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2018-07-05	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207398-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2018-07-05	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207398-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2018-07-05	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207398-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2018-07-05	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207398-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2018-07-05	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207398-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2018-07-05	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207398-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2018-07-05	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A207398-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2018-07-05	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A207398-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2018-07-05	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A207398-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2018-07-05	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A207398-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2018-07-05	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A207398-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2018-07-05	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207398-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2018-07-05	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A207398-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2018-07-05	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A207398-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2018-07-05	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207398-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2018-07-05	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207398-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2018-07-05	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207398-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2018-07-05	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207398-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2018-07-05	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A207398-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2018-07-05	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A207398-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2018-07-05	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207398-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2018-07-05	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A207398-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2018-07-05	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A207398-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2018-07-05	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A207398-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2018-07-05	`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	A207398-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207398-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207398-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207398-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207398-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207398-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207398-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207398-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207398-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207398-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207398-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207398-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207398-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207398-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207398-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207398-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207398-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207398-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207398-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207398-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207398-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207398-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A207398-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A207398-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A207398-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A207398-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A207398-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207398-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A207398-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A207398-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207398-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207398-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207398-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207398-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A207398-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A207398-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207398-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A207398-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A207398-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A207398-001	AB	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 · 14 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Azithromycin	AZITHROMYCIN	A-S Medication Solutions	882f71b1-b153-4856-b4a7-1a29ae9cf247	2026-07-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207398 application number: ANDA207398
Azithromycin	AZITHROMYCIN	A-S Medication Solutions	58308e8b-57bd-4e82-a2e8-24aac63194cd	2026-07-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207398 application number: ANDA207398
Azithromycin	AZITHROMYCIN	Bryant Ranch Prepack	2a8010dc-700f-45d3-94ca-ebe4a51acc1b	2026-07-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207398 application number: ANDA207398
Azithromycin	AZITHROMYCIN	Aurobindo Pharma Limited	795c13cd-e9ca-481b-9fa9-2890bdf9dac8	2026-04-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207398 application number: ANDA207398 ndc (product): 65862-642
Azithromycin	AZITHROMYCIN	Bryant Ranch Prepack	a81212ef-76b6-4bd7-8706-3d2b05ee34f9	2026-03-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207398 application number: ANDA207398 ndc (product): 63629-8251
Azithromycin	AZITHROMYCIN	A-S Medication Solutions	24c07398-84ad-48e2-9625-e9073c28fb73	2026-03-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207398 application number: ANDA207398 ndc (product): 50090-5376
Azithromycin	AZITHROMYCIN	A-S Medication Solutions	77c5e4c6-6d16-40fe-bf36-cb441348f39b	2026-03-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207398 application number: ANDA207398 ndc (product): 50090-5366
Azithromycin	AZITHROMYCIN	Preferred Pharmaceuticals Inc.	003307c5-3f73-4a5d-a704-bfdea3c656e8	2026-03-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207398 application number: ANDA207398 ndc (product): 68788-7598
Azithromycin	AZITHROMYCIN	Redpharm Drug	2fd25741-f014-3999-e063-6394a90acdd0	2025-12-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207398 application number: ANDA207398
Azithromycin	AZITHROMYCIN	NuCare Pharmaceuticals,Inc.	94e17ae5-0871-67a0-e053-2995a90ae0ae	2025-12-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207398 application number: ANDA207398 ndc (product): 68071-5082
AZITHROMYCIN	AZITHROMYCIN	Direct_Rx	8e6e11fb-eb9e-28ec-e053-2a95a90aa1a3	2025-01-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207398 application number: ANDA207398 ndc (product): 72189-015
Azithromycin	AZITHROMYCIN	NuCare Pharmaceuticals,Inc.	9270e676-3382-6483-e053-2a95a90a556e	2024-06-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207398 application number: ANDA207398 ndc (product): 68071-5058
Azithromycin	AZITHROMYCIN	NuCare Pharmaceuticals,Inc.	8e7184e1-3c3c-cd87-e053-2a95a90a6eb6	2024-06-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207398 application number: ANDA207398 ndc (product): 68071-4976
Azithromycin	AZITHROMYCIN	Proficient Rx LP	25f2d819-ae38-4061-a897-bbcfce3739bf	2022-03-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207398 application number: ANDA207398 ndc (product): 71205-519

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 37 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
16571-696	Azithromycin	Azithromycin	Rising Pharma Holdings, Inc.	ANDA	Current
16571-696	Azithromycin	Azithromycin	Rising Pharma Holdings, Inc.	ANDA	Current
16571-696	Azithromycin	Azithromycin	Rising Pharma Holdings, Inc.	ANDA	Current
16571-696	Azithromycin	Azithromycin	Rising Pharma Holdings, Inc.	ANDA	Current
50090-5366	Azithromycin	Azithromycin	A-S Medication Solutions	ANDA	Current
50090-5366	Azithromycin	Azithromycin	A-S Medication Solutions	ANDA	Current
50090-5366	Azithromycin	Azithromycin	A-S Medication Solutions	ANDA	Current
50090-5376	Azithromycin	Azithromycin	A-S Medication Solutions	ANDA	Current
50090-5376	Azithromycin	Azithromycin	A-S Medication Solutions	ANDA	Current
53002-0473	Azithromycin	Azithromycin	RPK Pharmaceuticals, Inc.	ANDA	Current
63629-8034	Azithromycin	Azithromycin	Bryant Ranch Prepack	ANDA	Current
63629-8034	Azithromycin	Azithromycin	Bryant Ranch Prepack	ANDA	Current
63629-8251	Azithromycin	Azithromycin	Bryant Ranch Prepack	ANDA	Current
63629-8251	Azithromycin	Azithromycin	Bryant Ranch Prepack	ANDA	Current
65862-642	Azithromycin	Azithromycin	Aurobindo Pharma Limited	ANDA	Current
65862-642	Azithromycin	Azithromycin	Aurobindo Pharma Limited	ANDA	Current
65862-642	Azithromycin	Azithromycin	Aurobindo Pharma Limited	ANDA	Current
65862-642	Azithromycin	Azithromycin	Aurobindo Pharma Limited	ANDA	Current
65862-642	Azithromycin	Azithromycin	Aurobindo Pharma Limited	ANDA	Current
68071-4976	Azithromycin	Azithromycin	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4976	Azithromycin	Azithromycin	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-5058	Azithromycin	Azithromycin	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-5058	Azithromycin	Azithromycin	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-5082	Azithromycin	Azithromycin	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-5082	Azithromycin	Azithromycin	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-5170	Azithromycin	Azithromycin	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-5170	Azithromycin	Azithromycin	NuCare Pharmaceuticals,Inc.	ANDA	Current
68788-7598	Azithromycin	Azithromycin	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7598	Azithromycin	Azithromycin	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7598	Azithromycin	Azithromycin	Preferred Pharmaceuticals Inc.	ANDA	Current
70518-3508	Azithromycin	Azithromycin	REMEDYREPACK INC.	ANDA	Current
71205-519	Azithromycin	Azithromycin	Proficient Rx LP	ANDA	Current
71205-519	Azithromycin	Azithromycin	Proficient Rx LP	ANDA	Current
71335-1252	Azithromycin	Azithromycin	Bryant Ranch Prepack	ANDA	Current
71335-1252	Azithromycin	Azithromycin	Bryant Ranch Prepack	ANDA	Current
72189-015	AZITHROMYCIN	AZITHROMYCIN	Direct_Rx	ANDA	Current
72189-015	AZITHROMYCIN	AZITHROMYCIN	Direct_Rx	ANDA	Current