Application 050797

Type: NDA
Sponsor: PF PRISM CV

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ZMAX	AZITHROMYCIN	FOR SUSPENSION, EXTENDED RELEASE;ORAL	EQ 2GM BASE/BOT	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
N050797-001	ZMAX	AZITHROMYCIN	EQ 2GM BASE/BOT	FOR SUSPENSION, EXTENDED RELEASE / ORAL		RLD	2005-06-10

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 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N050797-001	ZMAX	EQ 2GM BASE/BOT	FOR SUSPENSION, EXTENDED RELEASE / ORAL	RLD	2005-06-10	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N050797-001	ZMAX	EQ 2GM BASE/BOT	FOR SUSPENSION, EXTENDED RELEASE / ORAL	RLD	2005-06-10	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N050797-001	ZMAX	EQ 2GM BASE/BOT	FOR SUSPENSION, EXTENDED RELEASE / ORAL	RLD	2005-06-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050797-001	ZMAX	EQ 2GM BASE/BOT	FOR SUSPENSION, EXTENDED RELEASE / ORAL	RLD	2005-06-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N050797-001	ZMAX	EQ 2GM BASE/BOT	FOR SUSPENSION, EXTENDED RELEASE / ORAL	RLD	2005-06-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050797-001	ZMAX	EQ 2GM BASE/BOT	FOR SUSPENSION, EXTENDED RELEASE / ORAL	RLD	2005-06-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050797-001	ZMAX	EQ 2GM BASE/BOT	FOR SUSPENSION, EXTENDED RELEASE / ORAL	RLD	2005-06-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050797-001	ZMAX	EQ 2GM BASE/BOT	FOR SUSPENSION, EXTENDED RELEASE / ORAL	RLD	2005-06-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050797-001	ZMAX	EQ 2GM BASE/BOT	FOR SUSPENSION, EXTENDED RELEASE / ORAL	RLD	2005-06-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050797-001	ZMAX	EQ 2GM BASE/BOT	FOR SUSPENSION, EXTENDED RELEASE / ORAL	RLD	2005-06-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050797-001	ZMAX	EQ 2GM BASE/BOT	FOR SUSPENSION, EXTENDED RELEASE / ORAL	RLD	2005-06-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N050797-001	ZMAX	EQ 2GM BASE/BOT	FOR SUSPENSION, EXTENDED RELEASE / ORAL	RLD	2005-06-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050797-001	ZMAX	EQ 2GM BASE/BOT	FOR SUSPENSION, EXTENDED RELEASE / ORAL	RLD	2005-06-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050797-001	ZMAX	EQ 2GM BASE/BOT	FOR SUSPENSION, EXTENDED RELEASE / ORAL	RLD	2005-06-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050797-001	ZMAX	EQ 2GM BASE/BOT	FOR SUSPENSION, EXTENDED RELEASE / ORAL	RLD	2005-06-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N050797-001	ZMAX	EQ 2GM BASE/BOT	FOR SUSPENSION, EXTENDED RELEASE / ORAL	RLD	2005-06-10	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050797-001	ZMAX	EQ 2GM BASE/BOT	FOR SUSPENSION, EXTENDED RELEASE / ORAL	RLD	2005-06-10	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N050797-001	ZMAX	EQ 2GM BASE/BOT	FOR SUSPENSION, EXTENDED RELEASE / ORAL	RLD	2005-06-10	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N050797-001	ZMAX	EQ 2GM BASE/BOT	FOR SUSPENSION, EXTENDED RELEASE / ORAL	RLD	2005-06-10	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N050797-001	ZMAX	EQ 2GM BASE/BOT	FOR SUSPENSION, EXTENDED RELEASE / ORAL	RLD	2005-06-10	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N050797-001	ZMAX	EQ 2GM BASE/BOT	FOR SUSPENSION, EXTENDED RELEASE / ORAL	RLD	2005-06-10	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N050797-001	ZMAX	EQ 2GM BASE/BOT	FOR SUSPENSION, EXTENDED RELEASE / ORAL	RLD	2005-06-10	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N050797-001	ZMAX	EQ 2GM BASE/BOT	FOR SUSPENSION, EXTENDED RELEASE / ORAL	RLD	2005-06-10	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N050797-001	ZMAX	EQ 2GM BASE/BOT	FOR SUSPENSION, EXTENDED RELEASE / ORAL	RLD	2005-06-10	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N050797-001	ZMAX	EQ 2GM BASE/BOT	FOR SUSPENSION, EXTENDED RELEASE / ORAL	RLD	2005-06-10	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N050797-001	ZMAX	EQ 2GM BASE/BOT	FOR SUSPENSION, EXTENDED RELEASE / ORAL	RLD	2005-06-10	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N050797-001	ZMAX	EQ 2GM BASE/BOT	FOR SUSPENSION, EXTENDED RELEASE / ORAL	RLD	2005-06-10	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N050797-001	ZMAX	EQ 2GM BASE/BOT	FOR SUSPENSION, EXTENDED RELEASE / ORAL	RLD	2005-06-10	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N050797-001	ZMAX	EQ 2GM BASE/BOT	FOR SUSPENSION, EXTENDED RELEASE / ORAL	RLD	2005-06-10	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N050797-001	ZMAX	EQ 2GM BASE/BOT	FOR SUSPENSION, EXTENDED RELEASE / ORAL	RLD	2005-06-10	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N050797-001	ZMAX	EQ 2GM BASE/BOT	FOR SUSPENSION, EXTENDED RELEASE / ORAL	RLD	2005-06-10	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N050797-001	ZMAX	EQ 2GM BASE/BOT	FOR SUSPENSION, EXTENDED RELEASE / ORAL	RLD	2005-06-10	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N050797-001	ZMAX	EQ 2GM BASE/BOT	FOR SUSPENSION, EXTENDED RELEASE / ORAL	RLD	2005-06-10	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N050797-001	ZMAX	EQ 2GM BASE/BOT	FOR SUSPENSION, EXTENDED RELEASE / ORAL	RLD	2005-06-10	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N050797-001	ZMAX	EQ 2GM BASE/BOT	FOR SUSPENSION, EXTENDED RELEASE / ORAL	RLD	2005-06-10	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N050797-001	ZMAX	EQ 2GM BASE/BOT	FOR SUSPENSION, EXTENDED RELEASE / ORAL	RLD	2005-06-10	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N050797-001	ZMAX	EQ 2GM BASE/BOT	FOR SUSPENSION, EXTENDED RELEASE / ORAL	RLD	2005-06-10	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N050797-001	ZMAX	EQ 2GM BASE/BOT	FOR SUSPENSION, EXTENDED RELEASE / ORAL	RLD	2005-06-10	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N050797-001	ZMAX	EQ 2GM BASE/BOT	FOR SUSPENSION, EXTENDED RELEASE / ORAL	RLD	2005-06-10	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N050797-001	ZMAX	EQ 2GM BASE/BOT	FOR SUSPENSION, EXTENDED RELEASE / ORAL	RLD	2005-06-10	`f41ea6bd6efb…`

Observed Orange Book patent history#

Patent history page 2 of 2 · 70 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2019-09-15 20:21 UTC	2019-09	N050797-001	6984403	2024-02-14	U-282	Drug product		`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N050797-001	7887844	2024-02-14		Drug product	2011-03-15	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N050797-001	6984403	2024-02-14	U-282	Drug product		`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N050797-001	7887844	2024-02-14		Drug product	2011-03-15	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N050797-001	6984403	2024-02-14	U-282	Drug product		`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N050797-001	7887844	2024-02-14		Drug product	2011-03-15	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N050797-001	6984403	2024-02-14	U-282	Drug product		`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N050797-001	7887844	2024-02-14		Drug product	2011-03-15	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N050797-001	6984403	2024-02-14	U-282	Drug product		`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N050797-001	7887844	2024-02-14		Drug product	2011-03-15	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N050797-001	6984403	2024-02-14	U-282	Drug product		`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N050797-001	7887844	2024-02-14		Drug product	2011-03-15	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N050797-001	6984403	2024-02-14	U-282	Drug product		`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N050797-001	7887844	2024-02-14		Drug product	2011-03-15	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N050797-001	6984403	2024-02-14	U-282	Drug product		`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N050797-001	7887844	2024-02-14		Drug product	2011-03-15	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N050797-001	6984403	2024-02-14	U-282	Drug product		`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N050797-001	7887844	2024-02-14		Drug product	2011-03-15	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N050797-001	6984403	2024-02-14	U-282	Drug product		`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N050797-001	7887844	2024-02-14		Drug product	2011-03-15	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N050797-001	6984403	2024-02-14	U-282	Drug product		`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N050797-001	7887844	2024-02-14		Drug product	2011-03-15	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N050797-001	6984403	2024-02-14	U-282	Drug product		`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N050797-001	7887844	2024-02-14		Drug product	2011-03-15	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N050797-001	6984403	2024-02-14	U-282	Drug product		`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N050797-001	7887844	2024-02-14		Drug product	2011-03-15	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N050797-001	6984403	2024-02-14	U-282	Drug product		`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	N050797-001	7887844	2024-02-14		Drug product	2011-03-15	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N050797-001	6984403	2024-02-14	U-282	Drug product		`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N050797-001	7887844	2024-02-14		Drug product	2011-03-15	`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 5 · 99 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Azithromycin	AZITHROMYCIN	NuCare Pharmaceuticals,Inc.	94e17ae5-0871-67a0-e053-2995a90ae0ae	2026-09-09	Warnings, Adverse reactions	Name fallback generic name: AZITHROMYCIN
azithromycin	AZITHROMYCIN	REMEDYREPACK INC.	da399401-1ee6-422a-be46-0bba6b264b2f	2026-09-08	Warnings, Adverse reactions	Name fallback generic name: AZITHROMYCIN
Azithromycin	AZITHROMYCIN	Aurobindo Pharma Limited	3c902990-b870-4725-b9fe-76b8be633e1c	2026-09-03	Warnings, Adverse reactions	Name fallback generic name: AZITHROMYCIN
azithromycin	AZITHROMYCIN	Major Pharmaceuticals	814abe38-da4a-48af-bf4b-2ce04a5aabd1	2026-09-02	Warnings, Adverse reactions	Name fallback generic name: AZITHROMYCIN
azithromycin	AZITHROMYCIN	REMEDYREPACK INC.	bf061799-cdef-40f8-b1ce-bc5eb609f8c3	2026-09-02	Warnings, Adverse reactions	Name fallback generic name: AZITHROMYCIN
Azithromycin	AZITHROMYCIN	Aurobindo Pharma Limited	795c13cd-e9ca-481b-9fa9-2890bdf9dac8	2026-09-02	Warnings, Adverse reactions	Name fallback generic name: AZITHROMYCIN
azithromycin	AZITHROMYCIN	Lupin Pharmaceuticals, Inc.	01649d79-4677-4577-a3e4-e054f3f9fc3b	2026-08-20	Warnings, Adverse reactions	Name fallback generic name: AZITHROMYCIN
azithromycin	AZITHROMYCIN	Lupin Pharmaceuticals, Inc.	c9990a1d-5238-403e-9221-72a9314d7b5e	2026-08-20	Warnings, Adverse reactions	Name fallback generic name: AZITHROMYCIN
Azithromycin	AZITHROMYCIN	Zydus Pharmaceuticals USA Inc.	99e5bd22-a721-4e2e-a46c-d61a53c25c3d	2026-08-14	Warnings, Adverse reactions	Name fallback generic name: AZITHROMYCIN
Azithromycin	AZITHROMYCIN	REMEDYREPACK INC.	614cc2a4-3fc7-455d-9e8a-212c496f0fbf	2026-08-05	Warnings, Adverse reactions	Name fallback generic name: AZITHROMYCIN
Azithromycin	AZITHROMYCIN	Sandoz Inc	34b70c23-92a6-460f-8dbb-15a0e6b9d3a9	2026-07-30	Warnings, Adverse reactions	Name fallback generic name: AZITHROMYCIN
Azithromycin	AZITHROMYCIN	NuCare Pharmaceuticals,Inc.	a9cdb5ae-2aeb-c598-e053-2a95a90a8062	2026-07-30	Warnings, Adverse reactions	Name fallback generic name: AZITHROMYCIN
Azithromycin	AZITHROMYCIN	Sandoz Inc	ec619299-e0ef-44dd-acdb-8c53bbfc5b8a	2026-07-30	Warnings, Adverse reactions	Name fallback generic name: AZITHROMYCIN
Azithromycin	AZITHROMYCIN	A-S Medication Solutions	882f71b1-b153-4856-b4a7-1a29ae9cf247	2026-07-29	Warnings, Adverse reactions	Name fallback generic name: AZITHROMYCIN
Azithromycin	AZITHROMYCIN	Eugia US LLC	7b81436e-d14a-4353-a22d-253f45e2e576	2026-07-27	Warnings, Adverse reactions	Name fallback generic name: AZITHROMYCIN
Azithromycin	AZITHROMYCIN	A-S Medication Solutions	3b7e16b1-9a3c-4e3a-8411-841a708afe45	2026-07-23	Warnings, Adverse reactions	Name fallback generic name: AZITHROMYCIN
Azithromycin	AZITHROMYCIN	A-S Medication Solutions	58308e8b-57bd-4e82-a2e8-24aac63194cd	2026-07-23	Warnings, Adverse reactions	Name fallback generic name: AZITHROMYCIN
Azithromycin	AZITHROMYCIN	Bryant Ranch Prepack	2a8010dc-700f-45d3-94ca-ebe4a51acc1b	2026-07-20	Warnings, Adverse reactions	Name fallback generic name: AZITHROMYCIN
Azithromycin	AZITHROMYCIN	Bryant Ranch Prepack	6caeda98-7020-413a-9461-04f476dad4ba	2026-07-20	Warnings, Adverse reactions	Name fallback generic name: AZITHROMYCIN
Azithromycin	AZITHROMYCIN	A-S Medication Solutions	3c4861f2-825e-4e3b-9907-9658a849079e	2026-07-16	Warnings, Adverse reactions	Name fallback 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 · 1 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
21695-444	Zmax	azithromycin	Rebel Distributors Corp	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
69396	SUPPL	2021-11-23
69387	SUPPL	2021-11-23
58416	SUPPL	2019-04-25
58405	SUPPL	2019-04-24
47840	SUPPL	2017-04-03
47795	SUPPL	2017-03-31
47186	SUPPL	2017-02-13
47170	SUPPL	2017-02-10
8318	SUPPL	2016-05-26
39363	SUPPL	2016-05-25
8317	SUPPL	2015-07-10
39362	SUPPL	2015-07-06
39360	SUPPL	2013-10-17
30585	SUPPL	2013-10-15
44210	ORIG	2013-03-12
30588	SUPPL	2013-02-21
18283	SUPPL	2013-02-21
18282	SUPPL	2012-03-06
30587	SUPPL	2012-03-05
39361	SUPPL	2011-09-20
18281	SUPPL	2011-09-20
18280	SUPPL	2011-09-20
30586	SUPPL	2011-06-10
30584	SUPPL	2011-06-10
8316	SUPPL	2011-06-10
18279	SUPPL	2008-10-09
8315	SUPPL	2008-10-09
8314	SUPPL	2007-11-08
39359	SUPPL	2007-11-07
42744	ORIG	2007-09-10
30583	ORIG	2005-06-14
18278	ORIG	2005-06-14
53182	SUPPL	1900-01-01
53181	SUPPL	1900-01-01