Application 205666

Type: ANDA
Sponsor: AMNEAL PHARMS LLC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	AZITHROMYCIN	AZITHROMYCIN	FOR SUSPENSION;ORAL	EQ 100MG BASE/5ML	No	No
002	AZITHROMYCIN	AZITHROMYCIN	FOR SUSPENSION;ORAL	EQ 200MG BASE/5ML	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A205666-001	AZITHROMYCIN	AZITHROMYCIN	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL			2018-07-19
A205666-002	AZITHROMYCIN	AZITHROMYCIN	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL			2018-07-19

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 3 · 86 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
2026-09-14 22:38:34	2026-08	A205666-001	AZITHROMYCIN	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL		2018-07-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A205666-002	AZITHROMYCIN	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL		2018-07-19	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A205666-001	AZITHROMYCIN	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL		2018-07-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205666-002	AZITHROMYCIN	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL		2018-07-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A205666-001	AZITHROMYCIN	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL		2018-07-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205666-002	AZITHROMYCIN	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL		2018-07-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205666-001	AZITHROMYCIN	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL		2018-07-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205666-002	AZITHROMYCIN	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL		2018-07-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205666-001	AZITHROMYCIN	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2018-07-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205666-002	AZITHROMYCIN	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2018-07-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205666-001	AZITHROMYCIN	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2018-07-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205666-002	AZITHROMYCIN	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2018-07-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205666-001	AZITHROMYCIN	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2018-07-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205666-002	AZITHROMYCIN	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2018-07-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205666-001	AZITHROMYCIN	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2018-07-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205666-002	AZITHROMYCIN	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2018-07-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205666-001	AZITHROMYCIN	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2018-07-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205666-002	AZITHROMYCIN	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2018-07-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205666-001	AZITHROMYCIN	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2018-07-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205666-002	AZITHROMYCIN	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2018-07-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205666-001	AZITHROMYCIN	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2018-07-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205666-002	AZITHROMYCIN	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2018-07-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205666-001	AZITHROMYCIN	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2018-07-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205666-002	AZITHROMYCIN	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2018-07-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205666-001	AZITHROMYCIN	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2018-07-19	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205666-002	AZITHROMYCIN	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2018-07-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205666-001	AZITHROMYCIN	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2018-07-19	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205666-002	AZITHROMYCIN	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2018-07-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205666-001	AZITHROMYCIN	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2018-07-19	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205666-002	AZITHROMYCIN	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2018-07-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205666-001	AZITHROMYCIN	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2018-07-19	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A205666-002	AZITHROMYCIN	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2018-07-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205666-001	AZITHROMYCIN	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2018-07-19	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205666-002	AZITHROMYCIN	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2018-07-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A205666-001	AZITHROMYCIN	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2018-07-19	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A205666-002	AZITHROMYCIN	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2018-07-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A205666-001	AZITHROMYCIN	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2018-07-19	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A205666-002	AZITHROMYCIN	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2018-07-19	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A205666-001	AZITHROMYCIN	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2018-07-19	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A205666-002	AZITHROMYCIN	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2018-07-19	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 76 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-08-23 18:47 UTC	2025-08	A205666-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205666-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205666-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205666-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205666-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205666-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205666-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205666-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205666-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205666-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205666-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205666-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205666-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205666-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205666-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205666-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205666-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205666-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205666-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205666-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205666-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205666-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205666-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A205666-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205666-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205666-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A205666-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A205666-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A205666-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A205666-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A205666-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A205666-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A205666-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A205666-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A205666-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A205666-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A205666-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A205666-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A205666-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A205666-002	AB	1	`5aa47cf7b7d7…`

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 3 of 6 · 109 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
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	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
AZITHROMYCIN	AZITHROMYCIN	NuCare Pharmaceuticals, Inc.	3f7c7421-411d-c04e-e063-6394a90a4aa0	2025-09-23	Warnings, Adverse reactions	Name fallback brand name: AZITHROMYCIN generic name: AZITHROMYCIN
Azithromycin	AZITHROMYCIN	Zhejiang Poly Pharm. Co., Ltd.	33d0a4eb-5076-65c6-e063-6394a90ac13a	2025-08-22	Warnings, Adverse reactions	Name fallback brand name: Azithromycin generic name: AZITHROMYCIN
Azithromycin	AZITHROMYCIN MONOHYDRATE	Sagent Pharmaceuticals	cefbce3f-3e6c-4659-abd7-3ec3e8227737	2025-07-28	Warnings, Adverse reactions	Name fallback brand name: Azithromycin
Azithromycin	AZITHROMYCIN	Alembic Pharmaceuticals Inc.	4314da8a-40e5-4aba-a32b-57b4166ade30	2025-06-30	Warnings, Adverse reactions	Name fallback brand name: Azithromycin generic name: AZITHROMYCIN
Azithromycin	AZITHROMYCIN	American Health Packaging	6169e56c-10fb-448d-ab0f-14e54fcf2817	2025-06-12	Warnings, Adverse reactions	Name fallback brand name: Azithromycin generic name: AZITHROMYCIN
azithromycin	AZITHROMYCIN	Lannett Company, Inc.	a2b0c06b-e93d-f5aa-e053-2995a90ac9aa	2025-05-13	Warnings, Adverse reactions	Name fallback brand name: azithromycin generic name: AZITHROMYCIN
Azithromycin	AZITHROMYCIN	A-S Medication Solutions	47a8fd64-5a3d-490e-8ca8-5e6721c830cf	2025-05-01	Warnings, Adverse reactions	Name fallback brand name: Azithromycin generic name: AZITHROMYCIN
azithromycin	AZITHROMYCIN	Proficient Rx LP	25bc2e78-9d0d-41c6-a55e-a267d4457967	2025-04-01	Warnings, Adverse reactions	Name fallback brand name: azithromycin generic name: AZITHROMYCIN
Azithromycin	AZITHROMYCIN MONOHYDRATE	Athenex Pharmaceutical Division, LLC.	610a34ea-6aa7-4b94-a85a-ff16ca537d03	2025-01-28	Warnings, Adverse reactions	Name fallback brand name: Azithromycin
Azithromycin	AZITHROMYCIN MONOHYDRATE	Athenex Pharmaceutical Division, LLC.	324330c5-20fe-4b22-adf2-14a6e91e71ef	2025-01-28	Warnings, Adverse reactions	Name fallback brand name: Azithromycin

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 20 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
65162-708	Azithromycin Monohydrate	Azithromycin Monohydrate	Amneal Pharmaceuticals LLC	ANDA	Current
65162-708	Azithromycin Monohydrate	Azithromycin Monohydrate	Amneal Pharmaceuticals LLC	ANDA	Current
65162-708	Azithromycin Monohydrate	Azithromycin Monohydrate	Amneal Pharmaceuticals LLC	ANDA	Current
65162-708	Azithromycin Monohydrate	Azithromycin Monohydrate	Amneal Pharmaceuticals LLC	ANDA	Current
65162-708	Azithromycin Monohydrate	Azithromycin Monohydrate	Amneal Pharmaceuticals LLC	ANDA	Current
65162-758	Azithromycin Monohydrate	Azithromycin Monohydrate	Amneal Pharmaceuticals LLC	ANDA	Current
65162-758	Azithromycin Monohydrate	Azithromycin Monohydrate	Amneal Pharmaceuticals LLC	ANDA	Current
65162-758	Azithromycin Monohydrate	Azithromycin Monohydrate	Amneal Pharmaceuticals LLC	ANDA	Current
65162-758	Azithromycin Monohydrate	Azithromycin Monohydrate	Amneal Pharmaceuticals LLC	ANDA	Current
65162-758	Azithromycin Monohydrate	Azithromycin Monohydrate	Amneal Pharmaceuticals LLC	ANDA	Current
65162-759	Azithromycin Monohydrate	Azithromycin Monohydrate	Amneal Pharmaceuticals LLC	ANDA	Current
65162-759	Azithromycin Monohydrate	Azithromycin Monohydrate	Amneal Pharmaceuticals LLC	ANDA	Current
65162-759	Azithromycin Monohydrate	Azithromycin Monohydrate	Amneal Pharmaceuticals LLC	ANDA	Current
65162-759	Azithromycin Monohydrate	Azithromycin Monohydrate	Amneal Pharmaceuticals LLC	ANDA	Current
65162-759	Azithromycin Monohydrate	Azithromycin Monohydrate	Amneal Pharmaceuticals LLC	ANDA	Current
65162-760	Azithromycin Monohydrate	Azithromycin Monohydrate	Amneal Pharmaceuticals LLC	ANDA	Current
65162-760	Azithromycin Monohydrate	Azithromycin Monohydrate	Amneal Pharmaceuticals LLC	ANDA	Current
65162-760	Azithromycin Monohydrate	Azithromycin Monohydrate	Amneal Pharmaceuticals LLC	ANDA	Current
65162-760	Azithromycin Monohydrate	Azithromycin Monohydrate	Amneal Pharmaceuticals LLC	ANDA	Current
65162-760	Azithromycin Monohydrate	Azithromycin Monohydrate	Amneal Pharmaceuticals LLC	ANDA	Current