Application 050733

Type: NDA
Sponsor: PFIZER

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ZITHROMAX	AZITHROMYCIN	INJECTABLE;INJECTION	EQ 500MG BASE/VIAL	Yes	Yes

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

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
N050733-001	ZITHROMAX	AZITHROMYCIN	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION		RLD	1997-01-30

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 2 · 42 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
2026-08-18 06:07:40	2026-07	N050733-001	ZITHROMAX	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION		RLD	1997-01-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N050733-001	ZITHROMAX	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	1997-01-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050733-001	ZITHROMAX	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	1997-01-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N050733-001	ZITHROMAX	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	1997-01-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050733-001	ZITHROMAX	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	1997-01-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050733-001	ZITHROMAX	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	1997-01-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050733-001	ZITHROMAX	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	1997-01-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050733-001	ZITHROMAX	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	1997-01-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050733-001	ZITHROMAX	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	1997-01-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050733-001	ZITHROMAX	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	1997-01-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N050733-001	ZITHROMAX	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	1997-01-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050733-001	ZITHROMAX	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	1997-01-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050733-001	ZITHROMAX	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	1997-01-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050733-001	ZITHROMAX	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	1997-01-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N050733-001	ZITHROMAX	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	1997-01-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050733-001	ZITHROMAX	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	1997-01-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N050733-001	ZITHROMAX	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	1997-01-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N050733-001	ZITHROMAX	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	1997-01-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N050733-001	ZITHROMAX	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	1997-01-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N050733-001	ZITHROMAX	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	1997-01-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N050733-001	ZITHROMAX	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	1997-01-30	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N050733-001	ZITHROMAX	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	1997-01-30	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N050733-001	ZITHROMAX	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	1997-01-30	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N050733-001	ZITHROMAX	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	1997-01-30	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N050733-001	ZITHROMAX	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	1997-01-30	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N050733-001	ZITHROMAX	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	1997-01-30	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N050733-001	ZITHROMAX	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	1997-01-30	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N050733-001	ZITHROMAX	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	1997-01-30	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N050733-001	ZITHROMAX	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	1997-01-30	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N050733-001	ZITHROMAX	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	1997-01-30	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N050733-001	ZITHROMAX	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	1997-01-30	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N050733-001	ZITHROMAX	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	1997-01-30	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N050733-001	ZITHROMAX	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	1997-01-30	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N050733-001	ZITHROMAX	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	1997-01-30	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N050733-001	ZITHROMAX	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	1997-01-30	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N050733-001	ZITHROMAX	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	1997-01-30	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N050733-001	ZITHROMAX	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	1997-01-30	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N050733-001	ZITHROMAX	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	1997-01-30	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N050733-001	ZITHROMAX	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	1997-01-30	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N050733-001	ZITHROMAX	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	1997-01-30	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 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	N050733-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050733-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N050733-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050733-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050733-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050733-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050733-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050733-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050733-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N050733-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050733-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050733-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050733-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N050733-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050733-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N050733-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N050733-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N050733-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N050733-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N050733-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N050733-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N050733-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N050733-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N050733-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N050733-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N050733-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N050733-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N050733-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N050733-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N050733-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N050733-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N050733-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N050733-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N050733-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N050733-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N050733-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N050733-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N050733-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N050733-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N050733-001	AP	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 1 of 1 · 2 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	3b631aa1-2d46-40bc-a614-d698301ea4f9	2026-07-24	Warnings, Adverse reactions	Exact identifier application applno (NDA): 050733 application number: NDA050733 ndc (product): 0069-3150
Zithromax	AZITHROMYCIN DIHYDRATE	Pfizer Laboratories Div Pfizer Inc	8d24bacb-feff-4c6a-b8df-625e1435387a	2025-02-10	Warnings, Adverse reactions	Exact identifier application applno (NDA): 050733 application number: NDA050733 ndc (product): 0069-0400

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 18 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0069-0400	Zithromax	azithromycin dihydrate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0400	Zithromax	azithromycin dihydrate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0400	Zithromax	azithromycin dihydrate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0400	Zithromax	azithromycin dihydrate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0400	Zithromax	azithromycin dihydrate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0400	Zithromax	azithromycin dihydrate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0400	Zithromax	azithromycin dihydrate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0400	Zithromax	azithromycin dihydrate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0400	Zithromax	azithromycin dihydrate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-3150	Zithromax	azithromycin dihydrate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-3150	Zithromax	azithromycin dihydrate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-3150	Zithromax	azithromycin dihydrate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-3150	Zithromax	azithromycin dihydrate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-3150	Zithromax	azithromycin dihydrate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-3150	Zithromax	azithromycin dihydrate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-3150	Zithromax	azithromycin dihydrate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-3150	Zithromax	azithromycin dihydrate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
10019-648	azithromycin	azithromycin	Baxter Healthcare Corporation	NDA AUTHORIZED GENERIC	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
71517	SUPPL	2022-07-05
71514	SUPPL	2022-07-05
69405	SUPPL	2021-11-24
69391	SUPPL	2021-11-23
58428	ORIG	2019-04-26
58417	SUPPL	2019-04-25
47839	SUPPL	2017-04-03
47788	SUPPL	2017-03-30
47187	SUPPL	2017-02-13
47171	SUPPL	2017-02-13
30410	SUPPL	2016-05-26
39216	SUPPL	2016-05-25
39214	SUPPL	2014-06-10
30407	SUPPL	2014-06-10
23726	ORIG	2013-03-12
18143	SUPPL	2013-02-21
8144	SUPPL	2013-02-21
18142	SUPPL	2012-06-11
30409	SUPPL	2012-06-08
39215	SUPPL	2011-11-21
30408	SUPPL	2011-11-21
18141	SUPPL	2011-02-04
8143	SUPPL	2011-02-03
39213	SUPPL	2010-08-19
30406	SUPPL	2010-08-17
39212	SUPPL	2009-04-03
30405	SUPPL	2009-03-03
30404	SUPPL	2007-11-08
18140	SUPPL	2007-11-07
30403	SUPPL	2004-01-22
8142	SUPPL	2004-01-22
30402	SUPPL	2003-06-22
39211	SUPPL	2003-05-02
30401	SUPPL	2002-10-16
8141	SUPPL	2002-07-22
8140	SUPPL	2002-03-13
42708	ORIG	1997-01-30