Application 065419

Type: ANDA
Sponsor: TEVA PHARMS

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
A065419-001	AZITHROMYCIN	AZITHROMYCIN	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL			2008-06-24
A065419-002	AZITHROMYCIN	AZITHROMYCIN	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL			2008-06-24

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	A065419-001	AZITHROMYCIN	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL		2008-06-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A065419-002	AZITHROMYCIN	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL		2008-06-24	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A065419-001	AZITHROMYCIN	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL		2008-06-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A065419-002	AZITHROMYCIN	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL		2008-06-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A065419-001	AZITHROMYCIN	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL		2008-06-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065419-002	AZITHROMYCIN	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL		2008-06-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065419-001	AZITHROMYCIN	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL		2008-06-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065419-002	AZITHROMYCIN	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL		2008-06-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065419-001	AZITHROMYCIN	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL		2008-06-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065419-002	AZITHROMYCIN	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL		2008-06-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065419-001	AZITHROMYCIN	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL		2008-06-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065419-002	AZITHROMYCIN	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL		2008-06-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065419-001	AZITHROMYCIN	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL		2008-06-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065419-002	AZITHROMYCIN	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL		2008-06-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065419-001	AZITHROMYCIN	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL		2008-06-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065419-002	AZITHROMYCIN	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL		2008-06-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065419-001	AZITHROMYCIN	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL		2008-06-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065419-002	AZITHROMYCIN	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL		2008-06-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065419-001	AZITHROMYCIN	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL		2008-06-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065419-002	AZITHROMYCIN	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL		2008-06-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065419-001	AZITHROMYCIN	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL		2008-06-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065419-002	AZITHROMYCIN	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL		2008-06-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065419-001	AZITHROMYCIN	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL		2008-06-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065419-002	AZITHROMYCIN	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL		2008-06-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065419-001	AZITHROMYCIN	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL		2008-06-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065419-002	AZITHROMYCIN	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL		2008-06-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065419-001	AZITHROMYCIN	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL		2008-06-24	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065419-002	AZITHROMYCIN	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL		2008-06-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065419-001	AZITHROMYCIN	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL		2008-06-24	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065419-002	AZITHROMYCIN	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL		2008-06-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065419-001	AZITHROMYCIN	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL		2008-06-24	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A065419-002	AZITHROMYCIN	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL		2008-06-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065419-001	AZITHROMYCIN	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL		2008-06-24	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065419-002	AZITHROMYCIN	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL		2008-06-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065419-001	AZITHROMYCIN	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL		2008-06-24	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A065419-002	AZITHROMYCIN	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL		2008-06-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065419-001	AZITHROMYCIN	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL		2008-06-24	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A065419-002	AZITHROMYCIN	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL		2008-06-24	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065419-001	AZITHROMYCIN	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2008-06-24	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A065419-002	AZITHROMYCIN	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2008-06-24	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A065419-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A065419-002	AB	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A065419-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A065419-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A065419-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A065419-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A065419-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A065419-002	AB	1	`ea99ee380514…`

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 · 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	3c4861f2-825e-4e3b-9907-9658a849079e	2026-07-16	Warnings, Adverse reactions	Name fallback brand name: Azithromycin generic name: AZITHROMYCIN
Azithromycin	AZITHROMYCIN	REMEDYREPACK INC.	333ffe63-aaeb-4dff-b595-1c11209189a6	2026-07-01	Warnings, Adverse reactions	Name fallback brand name: Azithromycin generic name: AZITHROMYCIN
AZITHROMYCIN	AZITHROMYCIN	A-S Medication Solutions	76093152-e2d7-4fe1-8568-1f0fec1747c2	2026-07-01	Warnings, Adverse reactions	Name fallback brand name: AZITHROMYCIN generic name: AZITHROMYCIN
Azithromycin	AZITHROMYCIN	REMEDYREPACK INC.	943b9246-7733-44b1-875c-91d2ade78ac4	2026-06-29	Warnings, Adverse reactions	Name fallback brand name: Azithromycin generic name: AZITHROMYCIN
Azithromycin	AZITHROMYCIN	Preferred Pharmaceuticals Inc.	661ff7a6-6394-493d-a307-a1f607e5d117	2026-06-16	Warnings, Adverse reactions	Name fallback brand name: Azithromycin generic name: AZITHROMYCIN
Azithromycin	AZITHROMYCIN	Bryant Ranch Prepack	b5d79719-b1dc-469f-a19c-f8ba615138f0	2026-05-14	Warnings, Adverse reactions	Name fallback brand name: Azithromycin generic name: AZITHROMYCIN
azithromycin	AZITHROMYCIN	Coupler LLC	510024c9-6658-e08f-e063-6294a90a0793	2026-05-04	Warnings, Adverse reactions	Name fallback brand name: azithromycin generic name: AZITHROMYCIN
Azithromycin	AZITHROMYCIN	Sportpharm LLC	397471e5-76e2-462c-af30-bcc54fe00266	2026-04-24	Warnings, Adverse reactions	Name fallback brand name: Azithromycin generic name: AZITHROMYCIN
azithromycin	AZITHROMYCIN	Cardinal Health 107, LLC	ea128124-8712-4998-be46-47d43ef127d4	2026-04-10	Warnings, Adverse reactions	Name fallback brand name: azithromycin generic name: AZITHROMYCIN
Azithromycin	AZITHROMYCIN	Bryant Ranch Prepack	a81212ef-76b6-4bd7-8706-3d2b05ee34f9	2026-03-30	Warnings, Adverse reactions	Name fallback brand name: Azithromycin generic name: AZITHROMYCIN
Azithromycin	AZITHROMYCIN	A-S Medication Solutions	24c07398-84ad-48e2-9625-e9073c28fb73	2026-03-24	Warnings, Adverse reactions	Name fallback brand name: Azithromycin generic name: AZITHROMYCIN
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

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 · 7 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0093-7148	Azithromycin	Azithromycin Monohydrate	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-7149	Azithromycin	Azithromycin Monohydrate	Teva Pharmaceuticals USA, Inc.	ANDA	Current
21695-548	Azithromycin	Azithromycin monohydrate	Rebel Distributors Corp.	ANDA	Current
21695-549	Azithromycin	Azithromycin monohydrate	Rebel Distributors Corp.	ANDA	Current
66116-524	Azithromycin	Azithromycin Monohydrate	MedVantx, Inc.	ANDA	Current
68788-9045	Azithromycin	Azithromycin Monohydrate	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-9046	Azithromycin	Azithromycin Monohydrate	Preferred Pharmaceuticals, Inc.	ANDA	Current