Application 050710

Type: NDA
Sponsor: PFIZER

Application Products#

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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
N050710-001	ZITHROMAX	AZITHROMYCIN	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD	1995-10-19
N050710-002	ZITHROMAX	AZITHROMYCIN	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	1995-10-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N050710-001	AB
N050710-002	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 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N050710-001	ZITHROMAX	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD	1995-10-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N050710-002	ZITHROMAX	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	1995-10-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050710-001	ZITHROMAX	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD	1995-10-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050710-002	ZITHROMAX	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	1995-10-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N050710-001	ZITHROMAX	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD	1995-10-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N050710-002	ZITHROMAX	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	1995-10-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050710-001	ZITHROMAX	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD	1995-10-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050710-002	ZITHROMAX	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	1995-10-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050710-001	ZITHROMAX	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD	1995-10-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050710-002	ZITHROMAX	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	1995-10-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050710-001	ZITHROMAX	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD	1995-10-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050710-002	ZITHROMAX	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	1995-10-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050710-001	ZITHROMAX	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD	1995-10-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050710-002	ZITHROMAX	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	1995-10-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050710-001	ZITHROMAX	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD	1995-10-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050710-002	ZITHROMAX	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	1995-10-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050710-001	ZITHROMAX	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD	1995-10-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050710-002	ZITHROMAX	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	1995-10-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N050710-001	ZITHROMAX	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD	1995-10-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N050710-002	ZITHROMAX	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	1995-10-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050710-001	ZITHROMAX	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD	1995-10-19	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050710-002	ZITHROMAX	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	1995-10-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050710-001	ZITHROMAX	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD	1995-10-19	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050710-002	ZITHROMAX	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	1995-10-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050710-001	ZITHROMAX	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD	1995-10-19	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050710-002	ZITHROMAX	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	1995-10-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N050710-001	ZITHROMAX	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD	1995-10-19	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N050710-002	ZITHROMAX	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	1995-10-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050710-001	ZITHROMAX	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD	1995-10-19	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050710-002	ZITHROMAX	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	1995-10-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N050710-001	ZITHROMAX	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD	1995-10-19	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N050710-002	ZITHROMAX	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	1995-10-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N050710-001	ZITHROMAX	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD	1995-10-19	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N050710-002	ZITHROMAX	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	1995-10-19	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N050710-001	ZITHROMAX	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD	1995-10-19	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N050710-002	ZITHROMAX	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	1995-10-19	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N050710-001	ZITHROMAX	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD	1995-10-19	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N050710-002	ZITHROMAX	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	1995-10-19	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N050710-001	ZITHROMAX	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD	1995-10-19	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N050710-002	ZITHROMAX	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL	AB	RLD, RS	1995-10-19	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N050710-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N050710-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050710-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050710-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N050710-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N050710-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050710-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050710-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050710-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050710-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050710-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050710-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050710-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050710-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050710-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050710-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050710-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050710-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N050710-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N050710-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050710-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050710-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050710-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050710-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050710-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050710-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N050710-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N050710-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050710-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050710-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N050710-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N050710-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N050710-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N050710-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N050710-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N050710-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N050710-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N050710-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N050710-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N050710-002	AB	1	`782e0a99824c…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Zithromax	AZITHROMYCIN DIHYDRATE	Pfizer Laboratories Div Pfizer Inc	db52b91e-79f7-4cc1-9564-f2eee8e31c45	2026-07-24	Warnings, Adverse reactions	Exact identifier application applno (NDA): 050710 application number: NDA050710 ndc (product): 0069-3140 ndc (product): 0069-3110 ndc (product): 0069-3130 ndc (product): 0069-3120

NDC Listings For This Application#

NDC listings for this application page 1 of 2 · 105 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0069-3110	Zithromax	azithromycin dihydrate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-3110	Zithromax	azithromycin dihydrate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-3110	Zithromax	azithromycin dihydrate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-3110	Zithromax	azithromycin dihydrate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-3110	Zithromax	azithromycin dihydrate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-3110	Zithromax	azithromycin dihydrate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-3110	Zithromax	azithromycin dihydrate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-3110	Zithromax	azithromycin dihydrate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-3110	Zithromax	azithromycin dihydrate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-3110	Zithromax	azithromycin dihydrate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-3110	Zithromax	azithromycin dihydrate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-3120	Zithromax	azithromycin dihydrate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-3120	Zithromax	azithromycin dihydrate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-3120	Zithromax	azithromycin dihydrate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-3120	Zithromax	azithromycin dihydrate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-3120	Zithromax	azithromycin dihydrate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-3120	Zithromax	azithromycin dihydrate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-3120	Zithromax	azithromycin dihydrate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-3120	Zithromax	azithromycin dihydrate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-3120	Zithromax	azithromycin dihydrate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-3120	Zithromax	azithromycin dihydrate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-3120	Zithromax	azithromycin dihydrate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-3130	Zithromax	azithromycin dihydrate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-3130	Zithromax	azithromycin dihydrate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-3130	Zithromax	azithromycin dihydrate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-3130	Zithromax	azithromycin dihydrate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-3130	Zithromax	azithromycin dihydrate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-3130	Zithromax	azithromycin dihydrate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-3130	Zithromax	azithromycin dihydrate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-3130	Zithromax	azithromycin dihydrate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-3130	Zithromax	azithromycin dihydrate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-3130	Zithromax	azithromycin dihydrate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-3130	Zithromax	azithromycin dihydrate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-3140	Zithromax	azithromycin dihydrate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-3140	Zithromax	azithromycin dihydrate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-3140	Zithromax	azithromycin dihydrate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-3140	Zithromax	azithromycin dihydrate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-3140	Zithromax	azithromycin dihydrate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-3140	Zithromax	azithromycin dihydrate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-3140	Zithromax	azithromycin dihydrate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-3140	Zithromax	azithromycin dihydrate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-3140	Zithromax	azithromycin dihydrate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-3140	Zithromax	azithromycin dihydrate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-3140	Zithromax	azithromycin dihydrate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
35356-044	azithromycin	azithromycin	Lake Erie Medical DBA Quality Care Products LLC	NDA AUTHORIZED GENERIC	Current
50090-2491	azithromycin	azithromycin	A-S Medication Solutions	NDA AUTHORIZED GENERIC	Current
50090-2491	azithromycin	azithromycin	A-S Medication Solutions	NDA AUTHORIZED GENERIC	Current
50090-2491	azithromycin	azithromycin	A-S Medication Solutions	NDA AUTHORIZED GENERIC	Current
50090-2509	azithromycin	azithromycin	A-S Medication Solutions	NDA AUTHORIZED GENERIC	Current
50090-2509	azithromycin	azithromycin	A-S Medication Solutions	NDA AUTHORIZED GENERIC	Current
50090-2509	azithromycin	azithromycin	A-S Medication Solutions	NDA AUTHORIZED GENERIC	Current
55695-029	azithromycin	azithromycin	Department of State Health Services, Pharmacy Branch	NDA AUTHORIZED GENERIC	Current
55700-211	azithromycin	azithromycin	Lake Erie Medical DBA Quality Care Products LLC	NDA AUTHORIZED GENERIC	Current
59762-3110	azithromycin	azithromycin	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-3110	azithromycin	azithromycin	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-3110	azithromycin	azithromycin	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-3110	azithromycin	azithromycin	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-3110	azithromycin	azithromycin	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-3110	azithromycin	azithromycin	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-3110	azithromycin	azithromycin	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-3110	azithromycin	azithromycin	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-3110	azithromycin	azithromycin	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-3110	azithromycin	azithromycin	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-3110	azithromycin	azithromycin	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-3110	azithromycin	azithromycin	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-3120	azithromycin	azithromycin	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-3120	azithromycin	azithromycin	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-3120	azithromycin	azithromycin	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-3120	azithromycin	azithromycin	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-3120	azithromycin	azithromycin	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-3120	azithromycin	azithromycin	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-3120	azithromycin	azithromycin	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-3120	azithromycin	azithromycin	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-3120	azithromycin	azithromycin	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-3120	azithromycin	azithromycin	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-3120	azithromycin	azithromycin	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-3120	azithromycin	azithromycin	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-3130	azithromycin	azithromycin	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-3130	azithromycin	azithromycin	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-3130	azithromycin	azithromycin	Greenstone LLC	NDA AUTHORIZED GENERIC	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
69371	SUPPL	2021-11-22
58418	SUPPL	2019-04-25
58395	SUPPL	2019-04-24
47835	SUPPL	2017-04-03
47798	SUPPL	2017-03-31
47188	SUPPL	2017-02-13
47172	SUPPL	2017-02-13
18075	SUPPL	2016-05-25
8069	SUPPL	2016-05-25
30327	SUPPL	2014-06-11
18072	SUPPL	2014-06-10
23722	ORIG	2013-03-12
30329	SUPPL	2013-02-21
18074	SUPPL	2013-02-21
39158	SUPPL	2012-11-06
30326	SUPPL	2012-11-06
18073	SUPPL	2012-06-11
30328	SUPPL	2012-06-08
18071	SUPPL	2011-02-04
8068	SUPPL	2011-02-03
18070	SUPPL	2010-08-19
30325	SUPPL	2010-08-17
39157	SUPPL	2009-04-03
30324	SUPPL	2009-03-03
30323	SUPPL	2007-11-08
18069	SUPPL	2007-11-07
22193	SUPPL	2004-06-04
30321	SUPPL	2004-04-29
39156	SUPPL	2004-01-22
30322	SUPPL	2004-01-22
18068	SUPPL	2004-01-22
8066	SUPPL	2004-01-22
8067	SUPPL	2003-12-22
30320	SUPPL	2003-07-06
8063	SUPPL	2002-10-16
8065	SUPPL	2002-07-22
39155	SUPPL	2002-05-24
30319	SUPPL	2002-05-24
39154	SUPPL	2001-12-14
39153	SUPPL	2001-12-14
30318	SUPPL	2001-12-14
8064	SUPPL	2001-12-14