Application 065302

Type: ANDA
Sponsor: WOCKHARDT

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
003	AZITHROMYCIN	AZITHROMYCIN	TABLET;ORAL	EQ 600MG 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
A065302-003	AZITHROMYCIN	AZITHROMYCIN	EQ 600MG BASE	TABLET / ORAL	AB		2008-02-11

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A065302-003	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	A065302-003	AZITHROMYCIN	EQ 600MG BASE	TABLET / ORAL	AB	2008-02-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065302-003	AZITHROMYCIN	EQ 600MG BASE	TABLET / ORAL	AB	2008-02-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065302-003	AZITHROMYCIN	EQ 600MG BASE	TABLET / ORAL	AB	2008-02-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065302-003	AZITHROMYCIN	EQ 600MG BASE	TABLET / ORAL	AB	2008-02-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065302-003	AZITHROMYCIN	EQ 600MG BASE	TABLET / ORAL	AB	2008-02-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065302-003	AZITHROMYCIN	EQ 600MG BASE	TABLET / ORAL	AB	2008-02-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065302-003	AZITHROMYCIN	EQ 600MG BASE	TABLET / ORAL	AB	2008-02-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065302-003	AZITHROMYCIN	EQ 600MG BASE	TABLET / ORAL	AB	2008-02-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065302-003	AZITHROMYCIN	EQ 600MG BASE	TABLET / ORAL	AB	2008-02-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065302-003	AZITHROMYCIN	EQ 600MG BASE	TABLET / ORAL	AB	2008-02-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065302-003	AZITHROMYCIN	EQ 600MG BASE	TABLET / ORAL	AB	2008-02-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065302-003	AZITHROMYCIN	EQ 600MG BASE	TABLET / ORAL	AB	2008-02-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065302-003	AZITHROMYCIN	EQ 600MG BASE	TABLET / ORAL	AB	2008-02-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065302-003	AZITHROMYCIN	EQ 600MG BASE	TABLET / ORAL	AB	2008-02-11	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065302-003	AZITHROMYCIN	EQ 600MG BASE	TABLET / ORAL	AB	2008-02-11	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065302-003	AZITHROMYCIN	EQ 600MG BASE	TABLET / ORAL	AB	2008-02-11	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065302-003	AZITHROMYCIN	EQ 600MG BASE	TABLET / ORAL	AB	2008-02-11	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065302-003	AZITHROMYCIN	EQ 600MG BASE	TABLET / ORAL	AB	2008-02-11	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065302-003	AZITHROMYCIN	EQ 600MG BASE	TABLET / ORAL	AB	2008-02-11	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065302-003	AZITHROMYCIN	EQ 600MG BASE	TABLET / ORAL	AB	2008-02-11	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065302-003	AZITHROMYCIN	EQ 600MG BASE	TABLET / ORAL	AB	2008-02-11	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A065302-003	AZITHROMYCIN	EQ 600MG BASE	TABLET / ORAL	AB	2008-02-11	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A065302-003	AZITHROMYCIN	EQ 600MG BASE	TABLET / ORAL	AB	2008-02-11	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A065302-003	AZITHROMYCIN	EQ 600MG BASE	TABLET / ORAL	AB	2008-02-11	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A065302-003	AZITHROMYCIN	EQ 600MG BASE	TABLET / ORAL	AB	2008-02-11	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A065302-003	AZITHROMYCIN	EQ 600MG BASE	TABLET / ORAL	AB	2008-02-11	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A065302-003	AZITHROMYCIN	EQ 600MG BASE	TABLET / ORAL	AB	2008-02-11	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A065302-003	AZITHROMYCIN	EQ 600MG BASE	TABLET / ORAL	AB	2008-02-11	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A065302-003	AZITHROMYCIN	EQ 600MG BASE	TABLET / ORAL	AB	2008-02-11	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A065302-003	AZITHROMYCIN	EQ 600MG BASE	TABLET / ORAL	AB	2008-02-11	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A065302-003	AZITHROMYCIN	EQ 600MG BASE	TABLET / ORAL	AB	2008-02-11	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A065302-003	AZITHROMYCIN	EQ 600MG BASE	TABLET / ORAL	AB	2008-02-11	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A065302-003	AZITHROMYCIN	EQ 600MG BASE	TABLET / ORAL	AB	2008-02-11	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A065302-003	AZITHROMYCIN	EQ 600MG BASE	TABLET / ORAL	AB	2008-02-11	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A065302-003	AZITHROMYCIN	EQ 600MG BASE	TABLET / ORAL	AB	2008-02-11	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A065302-003	AZITHROMYCIN	EQ 600MG BASE	TABLET / ORAL	AB	2008-02-11	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A065302-003	AZITHROMYCIN	EQ 600MG BASE	TABLET / ORAL	AB	2008-02-11	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A065302-003	AZITHROMYCIN	EQ 600MG BASE	TABLET / ORAL	AB	2008-02-11	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A065302-003	AZITHROMYCIN	EQ 600MG BASE	TABLET / ORAL	AB	2008-02-11	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A065302-003	AZITHROMYCIN	EQ 600MG BASE	TABLET / ORAL	AB	2008-02-11	`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	A065302-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065302-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065302-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065302-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065302-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065302-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065302-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065302-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065302-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065302-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065302-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065302-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065302-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065302-003	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065302-003	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065302-003	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065302-003	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065302-003	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065302-003	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065302-003	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065302-003	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A065302-003	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A065302-003	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A065302-003	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A065302-003	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A065302-003	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A065302-003	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A065302-003	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A065302-003	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A065302-003	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A065302-003	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A065302-003	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A065302-003	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A065302-003	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A065302-003	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A065302-003	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A065302-003	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A065302-003	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A065302-003	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A065302-003	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 2 of 6 · 111 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Azithromycin	AZITHROMYCIN	A-S Medication Solutions	77c5e4c6-6d16-40fe-bf36-cb441348f39b	2026-03-24	Warnings, Adverse reactions	Name fallback brand name: Azithromycin generic name: AZITHROMYCIN
Azithromycin	AZITHROMYCIN	AvKARE	dc633b7d-5154-7e43-e053-2a95a90ad2a6	2026-03-17	Warnings, Adverse reactions	Name fallback brand name: Azithromycin generic name: AZITHROMYCIN
AZITHROMYCIN	AZITHROMYCIN	DIRECT RX	a5b4092d-ab72-f5d1-e053-2995a90ac582	2026-03-17	Warnings, Adverse reactions	Name fallback brand name: AZITHROMYCIN generic name: AZITHROMYCIN
Azithromycin	AZITHROMYCIN	Preferred Pharmaceuticals Inc.	003307c5-3f73-4a5d-a704-bfdea3c656e8	2026-03-16	Warnings, Adverse reactions	Name fallback brand name: Azithromycin generic name: AZITHROMYCIN
Azithromycin	AZITHROMYCIN	Preferred Pharmaceuticals Inc.	4eec460d-5ba8-4614-8700-219a9b4fc385	2026-03-16	Warnings, Adverse reactions	Name fallback brand name: Azithromycin generic name: AZITHROMYCIN
AZITHROMYCIN	AZITHROMYCIN	Preferred Pharmaceuticals, Inc.	9e4fbd52-43e4-4d87-a136-f4d680a8d0c1	2026-03-12	Warnings, Adverse reactions	Name fallback brand name: AZITHROMYCIN generic name: AZITHROMYCIN
Azithromycin	AZITHROMYCIN	Preferred Pharmaceuticals Inc.	ac327054-21ab-401c-a27a-48259db18f89	2026-03-11	Warnings, Adverse reactions	Name fallback brand name: Azithromycin generic name: AZITHROMYCIN
Azithromycin	AZITHROMYCIN	Preferred Pharmaceuticals Inc.	a1c96531-bbd2-4dc5-8eeb-3f0276cd0956	2026-03-11	Warnings, Adverse reactions	Name fallback brand name: Azithromycin generic name: AZITHROMYCIN
azithromycin	AZITHROMYCIN	Rising Pharma Holdings, Inc.	5199689f-8881-7757-e063-6394a90ae2eb	2026-02-26	Warnings, Adverse reactions	Name fallback brand name: azithromycin generic name: AZITHROMYCIN
AZITHROMYCIN	AZITHROMYCIN	A-S Medication Solutions	405ab07f-7d1d-4552-ad3b-2a03be8e9949	2026-02-17	Warnings, Adverse reactions	Name fallback brand name: AZITHROMYCIN generic name: AZITHROMYCIN
AZITHROMYCIN	AZITHROMYCIN	Epic Pharma, LLC	59c4b783-4ff7-4269-969b-58a10e12b12b	2026-02-04	Warnings, Adverse reactions	Name fallback brand name: AZITHROMYCIN generic name: AZITHROMYCIN
Azithromycin	AZITHROMYCIN	Sportpharm LLC	5f9e13f5-69ee-4220-90d9-31fa8660d880	2026-02-03	Warnings, Adverse reactions	Name fallback brand name: Azithromycin generic name: AZITHROMYCIN
Azithromycin	AZITHROMYCIN	Sportpharm LLC	60ec2020-148b-4a2a-96f2-dd09c590ecbb	2026-02-03	Warnings, Adverse reactions	Name fallback brand name: Azithromycin generic name: AZITHROMYCIN
Azithromycin	AZITHROMYCIN	AvKARE	16da30a2-d11c-7e8c-e063-6294a90a62e3	2026-01-13	Warnings, Adverse reactions	Name fallback brand name: Azithromycin generic name: AZITHROMYCIN
Azithromycin	AZITHROMYCIN	AiPing Pharmaceutical, Inc.	d6fb42ed-7dac-4a7b-9964-d367dd47dd5c	2026-01-10	Warnings, Adverse reactions	Name fallback brand name: Azithromycin generic name: AZITHROMYCIN
Azithromycin	AZITHROMYCIN	Redpharm Drug	2fd25741-f014-3999-e063-6394a90acdd0	2025-12-27	Warnings, Adverse reactions	Name fallback brand name: Azithromycin generic name: AZITHROMYCIN
Azithromycin	AZITHROMYCIN	Redpharm Drug	3745a0b0-7855-69eb-e063-6294a90ab6a8	2025-12-24	Warnings, Adverse reactions	Name fallback brand name: Azithromycin generic name: AZITHROMYCIN
Azithromycin	AZITHROMYCIN	NuCare Pharmaceuticals,Inc.	94e17ae5-0871-67a0-e053-2995a90ae0ae	2025-12-19	Warnings, Adverse reactions	Name fallback brand name: Azithromycin generic name: AZITHROMYCIN
Azithromycin	AZITHROMYCIN	Bionpharma Inc.	859bb02c-a4bc-46fa-9fc9-def1219b5dfb	2025-12-04	Warnings, Adverse reactions	Name fallback brand name: Azithromycin generic name: AZITHROMYCIN
AZITHROMYCIN	AZITHROMYCIN	PURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS	714f6f55-278a-4fcf-8d4e-2ad9b43623a3	2025-11-20	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 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
55648-962	AZITHROMYCIN	AZITHROMYCIN	WOCKHARDT LIMITED	ANDA	Current
62980-962	Azithromycin	Azithromycin	Vivimed Labs Limited	ANDA	Current
64679-962	Azithromycin	Azithromycin	Wockhardt USA LLC.	ANDA	Current
64679-962	Azithromycin	Azithromycin	Wockhardt USA LLC.	ANDA	Current
64679-962	Azithromycin	Azithromycin	Wockhardt USA LLC.	ANDA	Current
64679-962	Azithromycin	Azithromycin	Wockhardt USA LLC.	ANDA	Current