Application 211521

Type: ANDA
Sponsor: TARO

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	AZITHROMYCIN	AZITHROMYCIN	FOR SUSPENSION;ORAL	EQ 200MG BASE/5ML	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
A211521-001	AZITHROMYCIN	AZITHROMYCIN	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL			2019-12-11

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.

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	A211521-001	AZITHROMYCIN	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL		2019-12-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211521-001	AZITHROMYCIN	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL		2019-12-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211521-001	AZITHROMYCIN	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL		2019-12-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211521-001	AZITHROMYCIN	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL		2019-12-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211521-001	AZITHROMYCIN	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL		2019-12-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211521-001	AZITHROMYCIN	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL		2019-12-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211521-001	AZITHROMYCIN	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL		2019-12-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211521-001	AZITHROMYCIN	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL		2019-12-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211521-001	AZITHROMYCIN	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL		2019-12-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211521-001	AZITHROMYCIN	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL		2019-12-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211521-001	AZITHROMYCIN	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL		2019-12-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211521-001	AZITHROMYCIN	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL		2019-12-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211521-001	AZITHROMYCIN	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL		2019-12-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211521-001	AZITHROMYCIN	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL		2019-12-11	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211521-001	AZITHROMYCIN	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2019-12-11	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211521-001	AZITHROMYCIN	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2019-12-11	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211521-001	AZITHROMYCIN	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2019-12-11	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A211521-001	AZITHROMYCIN	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2019-12-11	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211521-001	AZITHROMYCIN	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2019-12-11	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211521-001	AZITHROMYCIN	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2019-12-11	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A211521-001	AZITHROMYCIN	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL		2019-12-11	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A211521-001	AZITHROMYCIN	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL		2019-12-11	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A211521-001	AZITHROMYCIN	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL		2019-12-11	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A211521-001	AZITHROMYCIN	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2019-12-11	`3f01610625f2…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211521-001	AZITHROMYCIN	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL		2019-12-11	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A211521-001	AZITHROMYCIN	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL		2019-12-11	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A211521-001	AZITHROMYCIN	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL		2019-12-11	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211521-001	AZITHROMYCIN	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL		2019-12-11	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211521-001	AZITHROMYCIN	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL		2019-12-11	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211521-001	AZITHROMYCIN	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL		2019-12-11	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A211521-001	AZITHROMYCIN	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL		2019-12-11	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A211521-001	AZITHROMYCIN	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL		2019-12-11	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A211521-001	AZITHROMYCIN	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL		2019-12-11	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211521-001	AZITHROMYCIN	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL		2019-12-11	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A211521-001	AZITHROMYCIN	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL		2019-12-11	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A211521-001	AZITHROMYCIN	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2019-12-11	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A211521-001	AZITHROMYCIN	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2019-12-11	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A211521-001	AZITHROMYCIN	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL		2019-12-11	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211521-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211521-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211521-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A211521-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211521-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211521-001	AB	1	`87673890dc5c…`
2019-12-14 00:12 UTC	2019-12	A211521-001	AB	1	`3f01610625f2…`
2022-09-29 23:25 UTC	2022-09	A211521-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A211521-001	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 3 of 6 · 111 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
azithromycin	AZITHROMYCIN	Lupin Pharmaceuticals, Inc.	01649d79-4677-4577-a3e4-e054f3f9fc3b	2025-10-23	Warnings, Adverse reactions	Name fallback brand name: azithromycin generic name: AZITHROMYCIN
azithromycin	AZITHROMYCIN	Lupin Pharmaceuticals, Inc.	c9990a1d-5238-403e-9221-72a9314d7b5e	2025-10-23	Warnings, Adverse reactions	Name fallback brand name: azithromycin generic name: AZITHROMYCIN
azithromycin	AZITHROMYCIN	REMEDYREPACK INC.	da399401-1ee6-422a-be46-0bba6b264b2f	2025-10-02	Warnings, Adverse reactions	Name fallback brand name: azithromycin generic name: AZITHROMYCIN
azithromycin	AZITHROMYCIN	REMEDYREPACK INC.	bf061799-cdef-40f8-b1ce-bc5eb609f8c3	2025-09-29	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	Major Pharmaceuticals	814abe38-da4a-48af-bf4b-2ce04a5aabd1	2025-07-03	Warnings, Adverse reactions	Name fallback brand name: azithromycin generic 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
AZITHROMYCIN	AZITHROMYCIN	Direct_Rx	8e6e11fb-eb9e-28ec-e053-2a95a90aa1a3	2025-01-22	Warnings, Adverse reactions	Name fallback brand name: AZITHROMYCIN generic name: AZITHROMYCIN
AZITHROMYCIN	AZITHROMYCIN	DirectRx	d564d91e-3039-c120-e053-2995a90ae6db	2025-01-21	Warnings, Adverse reactions	Name fallback brand name: AZITHROMYCIN generic name: AZITHROMYCIN
Azithromycin	AZITHROMYCIN	Zydus Lifesciences Limited	0b63649d-558c-4250-90ee-af6e1e5c6d2c	2025-01-09		Name fallback brand name: Azithromycin generic name: AZITHROMYCIN
Azithromycin	AZITHROMYCIN	Zydus Pharmaceuticals USA Inc.	99e5bd22-a721-4e2e-a46c-d61a53c25c3d	2025-01-09	Warnings, Adverse reactions	Name fallback brand name: Azithromycin generic name: AZITHROMYCIN
Azithromycin	AZITHROMYCIN	Advanced Rx Pharmacy of Tennessee, LLC	f175496a-4ad3-ce0d-e053-2a95a90a6613	2024-12-31	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 · 1 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
51672-4200	Azithromycin	AZITHROMYCIN MONOHYDRATE	Taro Pharmaceuticals U.S.A., Inc.	ANDA	Current