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 5 of 6 · 109 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Azithromycin	AZITHROMYCIN	NuCare Pharmaceuticals,Inc.	896cce83-23ac-f4ed-e053-2a95a90ad107	2024-06-14	Warnings, Adverse reactions	Name fallback brand name: Azithromycin generic name: AZITHROMYCIN
Azithromycin	AZITHROMYCIN	A-S Medication Solutions	4278e306-bc26-4282-93ce-f1405e0b5d4a	2024-06-12	Warnings, Adverse reactions	Name fallback brand name: Azithromycin generic name: AZITHROMYCIN
Azithromycin	AZITHROMYCIN	Chartwell RX, LLC	2c9de2e9-c20c-4660-a272-a22019f9fb02	2024-04-09	Warnings, Adverse reactions	Name fallback brand name: Azithromycin generic name: AZITHROMYCIN
Azithromycin	AZITHROMYCIN	Proficient Rx LP	44134421-cb0b-4e85-a3c8-d58bdb476fad	2024-04-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Azithromycin generic name: AZITHROMYCIN
Azithromycin	AZITHROMYCIN	STATE HEALTH SERVICES, TEXAS DEPARTMENT OF	2b821631-0df2-0fb2-e054-00144ff8d46c	2024-02-29	Warnings, Adverse reactions	Name fallback brand name: Azithromycin generic name: AZITHROMYCIN
Azithromycin	AZITHROMYCIN	Asclemed USA, Inc.	b77b347d-d357-4bdf-b985-49d9a1dd634c	2023-12-30	Warnings, Adverse reactions	Name fallback brand name: Azithromycin generic name: AZITHROMYCIN
Azithromycin	AZITHROMYCIN	Bionpharma Inc.	a2754618-3df1-4b89-aa09-fdff4b71b7e4	2023-12-24	Warnings, Adverse reactions	Name fallback brand name: Azithromycin generic name: AZITHROMYCIN
Azithromycin	AZITHROMYCIN	A-S Medication Solutions	5ed68b5a-4093-49f1-871b-7b0da5f7be2d	2023-10-31	Warnings, Adverse reactions	Name fallback brand name: Azithromycin generic name: AZITHROMYCIN
Azithromycin	AZITHROMYCIN	Asclemed USA, Inc.	9c44af6d-8a9a-cb4c-e053-2a95a90afdac	2023-09-01	Warnings, Adverse reactions	Name fallback brand name: Azithromycin generic name: AZITHROMYCIN
Azithromycin	AZITHROMYCIN	A-S Medication Solutions	af720986-48a9-48b5-bdd7-370f6a2f92e1	2023-04-24	Warnings, Adverse reactions	Name fallback brand name: Azithromycin generic name: AZITHROMYCIN
Azithromycin	AZITHROMYCIN	Teva Pharmaceuticals USA, Inc.	f6a52c0b-45db-422e-8c22-e867a11b4439	2023-03-01	Warnings, Adverse reactions	Name fallback brand name: Azithromycin generic name: AZITHROMYCIN
Azithromycin	AZITHROMYCIN	A-S Medication Solutions	22a2bdcb-3012-42fb-ac66-d1d879100940	2023-02-06	Warnings, Adverse reactions	Name fallback brand name: Azithromycin generic name: AZITHROMYCIN
AZITHROMYCIN	AZITHROMYCIN	Alembic Pharmaceuticals Limited	5dca5a11-3c02-4a51-a35d-f91f37b8e00c	2023-01-27	Warnings, Adverse reactions	Name fallback brand name: AZITHROMYCIN generic name: AZITHROMYCIN
Azithromycin	AZITHROMYCIN	Alembic Pharmaceuticals Limited	d5c95c30-564f-4b67-ac6d-9179cdfaa5a8	2023-01-13	Warnings, Adverse reactions	Name fallback brand name: Azithromycin generic name: AZITHROMYCIN
Azithromycin	AZITHROMYCIN	Alembic Pharmaceuticals Limited	deea1a56-84ed-4ce4-9d11-03271510c0a1	2023-01-12	Warnings, Adverse reactions	Name fallback brand name: Azithromycin generic name: AZITHROMYCIN
Azithromycin	AZITHROMYCIN DIHYDRATE	Slate Run Pharmaceuticals	8acce3c1-f4be-4968-a71f-3ffd9fbaa4a4	2022-12-01	Warnings, Adverse reactions	Name fallback brand name: Azithromycin
AZITHROMYCIN	AZITHROMYCIN	Proficient Rx LP	e1172805-0930-4fb9-8a2f-e0d6a0430630	2022-11-01	Warnings, Adverse reactions	Name fallback brand name: AZITHROMYCIN generic name: AZITHROMYCIN
Azithromycin	AZITHROMYCIN	Proficient Rx LP	34e6364a-ac3d-434e-a90c-cb13ebcf7983	2022-11-01	Warnings, Adverse reactions	Name fallback brand name: Azithromycin generic name: AZITHROMYCIN
Azithromycin	AZITHROMYCIN	Proficient Rx LP	33140df5-420d-469f-b6c8-121e952a5cb6	2022-11-01	Warnings, Adverse reactions	Name fallback brand name: Azithromycin generic name: AZITHROMYCIN
AZITHROMYCIN	AZITHROMYCIN	Proficient Rx LP	b3761d39-9b79-4908-8b05-a1c91e599998	2022-11-01	Warnings, Adverse reactions	Name fallback brand name: AZITHROMYCIN generic 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