Application 207370

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 250MG 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
A207370-001	AZITHROMYCIN	AZITHROMYCIN	EQ 250MG 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
A207370-001	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	A207370-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2018-07-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207370-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2018-07-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207370-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2018-07-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207370-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2018-07-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207370-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2018-07-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207370-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2018-07-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207370-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2018-07-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207370-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2018-07-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207370-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2018-07-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207370-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2018-07-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207370-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2018-07-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207370-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2018-07-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207370-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2018-07-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207370-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2018-07-05	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207370-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2018-07-05	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207370-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2018-07-05	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207370-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2018-07-05	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207370-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2018-07-05	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207370-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2018-07-05	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207370-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2018-07-05	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207370-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2018-07-05	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207370-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2018-07-05	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A207370-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2018-07-05	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A207370-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2018-07-05	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A207370-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2018-07-05	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A207370-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2018-07-05	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A207370-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2018-07-05	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207370-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2018-07-05	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A207370-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2018-07-05	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A207370-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2018-07-05	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207370-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2018-07-05	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207370-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2018-07-05	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207370-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2018-07-05	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207370-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2018-07-05	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A207370-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2018-07-05	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A207370-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2018-07-05	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207370-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2018-07-05	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A207370-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2018-07-05	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A207370-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2018-07-05	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A207370-001	AZITHROMYCIN	EQ 250MG 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	A207370-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207370-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207370-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207370-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207370-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207370-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207370-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207370-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207370-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207370-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207370-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207370-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207370-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207370-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207370-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207370-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207370-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207370-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207370-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207370-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207370-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207370-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A207370-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A207370-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A207370-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A207370-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A207370-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207370-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A207370-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A207370-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207370-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207370-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207370-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207370-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A207370-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A207370-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207370-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A207370-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A207370-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A207370-001	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 · 12 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	Exact identifier application applno (ANDA): 207370 application number: ANDA207370 ndc (product): 68071-4812
Azithromycin	AZITHROMYCIN	REMEDYREPACK INC.	5f144e92-c9eb-420a-9bb8-4265a9f20a98	2026-07-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207370 application number: ANDA207370 ndc (product): 70518-2433
Azithromycin	AZITHROMYCIN	A-S Medication Solutions	3b7e16b1-9a3c-4e3a-8411-841a708afe45	2026-07-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207370 application number: ANDA207370
Azithromycin	AZITHROMYCIN	Bryant Ranch Prepack	6caeda98-7020-413a-9461-04f476dad4ba	2026-07-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207370 application number: ANDA207370
Azithromycin	AZITHROMYCIN	A-S Medication Solutions	3c4861f2-825e-4e3b-9907-9658a849079e	2026-07-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207370 application number: ANDA207370
Azithromycin	AZITHROMYCIN	Aurobindo Pharma Limited	795c13cd-e9ca-481b-9fa9-2890bdf9dac8	2026-04-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207370 application number: ANDA207370 ndc (product): 65862-641
AZITHROMYCIN	AZITHROMYCIN	DIRECT RX	a5b4092d-ab72-f5d1-e053-2995a90ac582	2026-03-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207370 application number: ANDA207370 ndc (product): 72189-087
Azithromycin	AZITHROMYCIN	Preferred Pharmaceuticals Inc.	4eec460d-5ba8-4614-8700-219a9b4fc385	2026-03-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207370 application number: ANDA207370
Azithromycin	AZITHROMYCIN	A-S Medication Solutions	47a8fd64-5a3d-490e-8ca8-5e6721c830cf	2025-05-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207370 application number: ANDA207370 ndc (product): 50090-4720
Azithromycin	AZITHROMYCIN	NuCare Pharmaceuticals,Inc.	896cce83-23ac-f4ed-e053-2a95a90ad107	2024-06-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207370 application number: ANDA207370 ndc (product): 68071-4902
Azithromycin	AZITHROMYCIN	A-S Medication Solutions	4278e306-bc26-4282-93ce-f1405e0b5d4a	2024-06-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207370 application number: ANDA207370 ndc (product): 50090-4721
Azithromycin	AZITHROMYCIN	Proficient Rx LP	cb40f4cf-15ae-47ab-8e0a-979467fa0d9e	2022-06-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207370 application number: ANDA207370 ndc (product): 71205-158

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 51 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
16571-695	Azithromycin	Azithromycin	Rising Pharma Holdings, Inc.	ANDA	Current
16571-695	Azithromycin	Azithromycin	Rising Pharma Holdings, Inc.	ANDA	Current
16571-695	Azithromycin	Azithromycin	Rising Pharma Holdings, Inc.	ANDA	Current
16571-695	Azithromycin	Azithromycin	Rising Pharma Holdings, Inc.	ANDA	Current
50090-4720	Azithromycin	Azithromycin	A-S Medication Solutions	ANDA	Current
50090-4720	Azithromycin	Azithromycin	A-S Medication Solutions	ANDA	Current
50090-4720	Azithromycin	Azithromycin	A-S Medication Solutions	ANDA	Current
50090-4721	Azithromycin	Azithromycin	A-S Medication Solutions	ANDA	Current
50090-4721	Azithromycin	Azithromycin	A-S Medication Solutions	ANDA	Current
50090-4721	Azithromycin	Azithromycin	A-S Medication Solutions	ANDA	Current
53002-5228	Azithromycin	Azithromycin	RPK Pharmaceuticals, Inc.	ANDA	Current
55700-852	Azithromycin	Azithromycin	Quality Care Products, LLC	ANDA	Current
55700-852	Azithromycin	Azithromycin	Quality Care Products, LLC	ANDA	Current
60760-502	Azithromycin	Azithromycin	St. Mary's Medical Park Pharmacy	ANDA	Current
65862-641	Azithromycin	Azithromycin	Aurobindo Pharma Limited	ANDA	Current
65862-641	Azithromycin	Azithromycin	Aurobindo Pharma Limited	ANDA	Current
65862-641	Azithromycin	Azithromycin	Aurobindo Pharma Limited	ANDA	Current
65862-641	Azithromycin	Azithromycin	Aurobindo Pharma Limited	ANDA	Current
65862-641	Azithromycin	Azithromycin	Aurobindo Pharma Limited	ANDA	Current
68071-2672	Azithromycin	Azithromycin	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-2905	Azithromycin	Azithromycin	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4786	Azithromycin	Azithromycin	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4786	Azithromycin	Azithromycin	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4812	Azithromycin	Azithromycin	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4812	Azithromycin	Azithromycin	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4812	Azithromycin	Azithromycin	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4812	Azithromycin	Azithromycin	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4902	Azithromycin	Azithromycin	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4902	Azithromycin	Azithromycin	NuCare Pharmaceuticals,Inc.	ANDA	Current
68788-7507	Azithromycin	Azithromycin	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-7507	Azithromycin	Azithromycin	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-7507	Azithromycin	Azithromycin	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-7507	Azithromycin	Azithromycin	Preferred Pharmaceuticals, Inc.	ANDA	Current
70518-2433	Azithromycin	Azithromycin	REMEDYREPACK INC.	ANDA	Current
70518-2433	Azithromycin	Azithromycin	REMEDYREPACK INC.	ANDA	Current
70518-2433	Azithromycin	Azithromycin	REMEDYREPACK INC.	ANDA	Current
70518-2433	Azithromycin	Azithromycin	REMEDYREPACK INC.	ANDA	Current
70518-2433	Azithromycin	Azithromycin	REMEDYREPACK INC.	ANDA	Current
70518-2433	Azithromycin	Azithromycin	REMEDYREPACK INC.	ANDA	Current
70518-2433	Azithromycin	Azithromycin	REMEDYREPACK INC.	ANDA	Current
71205-158	Azithromycin	Azithromycin	Proficient Rx LP	ANDA	Current
71205-158	Azithromycin	Azithromycin	Proficient Rx LP	ANDA	Current
71205-158	Azithromycin	Azithromycin	Proficient Rx LP	ANDA	Current
71205-158	Azithromycin	Azithromycin	Proficient Rx LP	ANDA	Current
71335-1195	Azithromycin	Azithromycin	Bryant Ranch Prepack	ANDA	Current
71335-1195	Azithromycin	Azithromycin	Bryant Ranch Prepack	ANDA	Current
71335-1195	Azithromycin	Azithromycin	Bryant Ranch Prepack	ANDA	Current
72189-087	AZITHROMYCIN	AZITHROMYCIN	DIRECT RX	ANDA	Current
72189-087	AZITHROMYCIN	AZITHROMYCIN	DIRECT RX	ANDA	Current
72189-087	AZITHROMYCIN	AZITHROMYCIN	DIRECT RX	ANDA	Current
72189-087	AZITHROMYCIN	AZITHROMYCIN	DIRECT RX	ANDA	Current