Application 065246

Type: ANDA
Sponsor: PLIVA

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
002	AZITHROMYCIN	AZITHROMYCIN	FOR SUSPENSION;ORAL	EQ 100MG BASE/5ML	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A065246-001	AZITHROMYCIN	AZITHROMYCIN	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL	AB		2006-07-05
A065246-002	AZITHROMYCIN	AZITHROMYCIN	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL	AB		2006-07-05

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A065246-001	AB
A065246-002	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 3 · 84 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
2026-08-18 06:07:40	2026-07	A065246-001	AZITHROMYCIN	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2006-07-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A065246-002	AZITHROMYCIN	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2006-07-05	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A065246-001	AZITHROMYCIN	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2006-07-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065246-002	AZITHROMYCIN	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2006-07-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065246-001	AZITHROMYCIN	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2006-07-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065246-002	AZITHROMYCIN	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2006-07-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065246-001	AZITHROMYCIN	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2006-07-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065246-002	AZITHROMYCIN	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2006-07-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065246-001	AZITHROMYCIN	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2006-07-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065246-002	AZITHROMYCIN	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2006-07-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065246-001	AZITHROMYCIN	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2006-07-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065246-002	AZITHROMYCIN	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2006-07-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065246-001	AZITHROMYCIN	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2006-07-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065246-002	AZITHROMYCIN	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2006-07-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065246-001	AZITHROMYCIN	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2006-07-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065246-002	AZITHROMYCIN	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2006-07-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065246-001	AZITHROMYCIN	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2006-07-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065246-002	AZITHROMYCIN	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2006-07-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065246-001	AZITHROMYCIN	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2006-07-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065246-002	AZITHROMYCIN	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2006-07-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065246-001	AZITHROMYCIN	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2006-07-05	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065246-002	AZITHROMYCIN	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2006-07-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065246-001	AZITHROMYCIN	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2006-07-05	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065246-002	AZITHROMYCIN	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2006-07-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065246-001	AZITHROMYCIN	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2006-07-05	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065246-002	AZITHROMYCIN	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2006-07-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065246-001	AZITHROMYCIN	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2006-07-05	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065246-002	AZITHROMYCIN	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2006-07-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065246-001	AZITHROMYCIN	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2006-07-05	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A065246-002	AZITHROMYCIN	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2006-07-05	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065246-001	AZITHROMYCIN	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2006-07-05	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065246-002	AZITHROMYCIN	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2006-07-05	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065246-001	AZITHROMYCIN	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2006-07-05	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A065246-002	AZITHROMYCIN	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2006-07-05	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065246-001	AZITHROMYCIN	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2006-07-05	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A065246-002	AZITHROMYCIN	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2006-07-05	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065246-001	AZITHROMYCIN	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2006-07-05	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A065246-002	AZITHROMYCIN	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2006-07-05	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065246-001	AZITHROMYCIN	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2006-07-05	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A065246-002	AZITHROMYCIN	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2006-07-05	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A065246-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A065246-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A065246-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065246-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065246-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065246-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065246-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065246-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065246-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065246-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065246-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065246-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065246-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065246-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065246-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065246-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065246-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065246-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065246-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065246-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065246-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065246-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065246-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065246-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065246-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065246-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065246-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065246-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065246-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A065246-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065246-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065246-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065246-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A065246-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065246-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A065246-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065246-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A065246-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065246-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A065246-002	AB	1	`bb7c543d1eb4…`

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 1 of 1 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Azithromycin	AZITHROMYCIN	Preferred Pharmaceuticals Inc.	ac327054-21ab-401c-a27a-48259db18f89	2026-03-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065246 application number: ANDA065246
Azithromycin	AZITHROMYCIN	A-S Medication Solutions	f97d2e7e-ccfd-4f04-85ba-549b37f6aa7b	2024-07-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065246 application number: ANDA065246
Azithromycin	AZITHROMYCIN	NuCare Pharmaceuticals,Inc.	549cdd0a-da79-23b8-e054-00144ff8d46c	2024-07-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065246 application number: ANDA065246 ndc (product): 68071-1527
Azithromycin	AZITHROMYCIN	Proficient Rx LP	44134421-cb0b-4e85-a3c8-d58bdb476fad	2024-04-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065246 application number: ANDA065246 ndc (product): 63187-093
Azithromycin	AZITHROMYCIN	STATE HEALTH SERVICES, TEXAS DEPARTMENT OF	2b821631-0df2-0fb2-e054-00144ff8d46c	2024-02-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065246 application number: ANDA065246 ndc (product): 55695-003 ndc (product): 55695-002
Azithromycin	AZITHROMYCIN	Teva Pharmaceuticals USA, Inc.	3209b147-11ce-4eeb-8427-5f8e6fb2c83d	2022-07-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065246 application number: ANDA065246 ndc (product): 0093-2027 ndc (product): 0093-2026

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 32 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0093-2026	Azithromycin	Azithromycin	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-2026	Azithromycin	Azithromycin	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-2026	Azithromycin	Azithromycin	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-2026	Azithromycin	Azithromycin	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-2027	Azithromycin	Azithromycin	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-2027	Azithromycin	Azithromycin	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-2027	Azithromycin	Azithromycin	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-2027	Azithromycin	Azithromycin	Teva Pharmaceuticals USA, Inc.	ANDA	Current
35356-199	Azithromycin	Azithromycin	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
50090-0983	Azithromycin	Azithromycin	A-S Medication Solutions	ANDA	Current
50090-0983	Azithromycin	Azithromycin	A-S Medication Solutions	ANDA	Current
50090-0984	Azithromycin	Azithromycin	A-S Medication Solutions	ANDA	Current
50090-0984	Azithromycin	Azithromycin	A-S Medication Solutions	ANDA	Current
53002-2230	Azithromycin	Azithromycin	RPK Pharmaceuticals, Inc.	ANDA	Current
55695-002	Azithromycin	Azithromycin	Department of State Health Services, Pharmacy Branch	ANDA	Current
55695-002	Azithromycin	Azithromycin	STATE HEALTH SERVICES, TEXAS DEPARTMENT OF	ANDA	Current
55695-003	Azithromycin	Azithromycin	Department of State Health Services, Pharmacy Branch	ANDA	Current
55695-003	Azithromycin	Azithromycin	STATE HEALTH SERVICES, TEXAS DEPARTMENT OF	ANDA	Current
61919-382	AZITHROMYCIN	AZITHROMYCIN	DIRECT RX	ANDA	Current
63187-093	Azithromycin	Azithromycin	Proficient Rx LP	ANDA	Current
63187-093	Azithromycin	Azithromycin	Proficient Rx LP	ANDA	Current
63187-093	Azithromycin	Azithromycin	Proficient Rx LP	ANDA	Current
68071-1527	Azithromycin	Azithromycin	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-1527	Azithromycin	Azithromycin	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-1527	Azithromycin	Azithromycin	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-1528	Azithromycin	Azithromycin	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-1528	Azithromycin	Azithromycin	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-1605	Azithromycin	Azithromycin	NuCare Pharmaceuticals,Inc.	ANDA	Current
68788-9958	Azithromycin	Azithromycin	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-9958	Azithromycin	Azithromycin	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-9959	Azithromycin	Azithromycin	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-9959	Azithromycin	Azithromycin	Preferred Pharmaceuticals, Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
30657	ORIG	2006-07-13