Application 050810

Type: NDA
Sponsor: OAK PHARMS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	AZASITE	AZITHROMYCIN	SOLUTION/DROPS;OPHTHALMIC	1%	Yes	Yes

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

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
N050810-001	AZASITE	AZITHROMYCIN	1%	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	2007-04-27

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 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N050810-001	AZASITE	1%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2007-04-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050810-001	AZASITE	1%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2007-04-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N050810-001	AZASITE	1%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2007-04-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050810-001	AZASITE	1%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2007-04-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050810-001	AZASITE	1%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2007-04-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050810-001	AZASITE	1%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2007-04-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050810-001	AZASITE	1%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2007-04-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050810-001	AZASITE	1%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2007-04-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050810-001	AZASITE	1%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2007-04-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N050810-001	AZASITE	1%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2007-04-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050810-001	AZASITE	1%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2007-04-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050810-001	AZASITE	1%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2007-04-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050810-001	AZASITE	1%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2007-04-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N050810-001	AZASITE	1%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2007-04-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050810-001	AZASITE	1%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2007-04-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N050810-001	AZASITE	1%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2007-04-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N050810-001	AZASITE	1%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2007-04-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N050810-001	AZASITE	1%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2007-04-27	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N050810-001	AZASITE	1%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2007-04-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N050810-001	AZASITE	1%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2007-04-27	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N050810-001	AZASITE	1%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2007-04-27	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N050810-001	AZASITE	1%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2007-04-27	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N050810-001	AZASITE	1%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2007-04-27	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N050810-001	AZASITE	1%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2007-04-27	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N050810-001	AZASITE	1%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2007-04-27	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N050810-001	AZASITE	1%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2007-04-27	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N050810-001	AZASITE	1%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2007-04-27	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N050810-001	AZASITE	1%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2007-04-27	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N050810-001	AZASITE	1%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2007-04-27	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N050810-001	AZASITE	1%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2007-04-27	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N050810-001	AZASITE	1%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2007-04-27	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N050810-001	AZASITE	1%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2007-04-27	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N050810-001	AZASITE	1%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2007-04-27	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N050810-001	AZASITE	1%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2007-04-27	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N050810-001	AZASITE	1%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2007-04-27	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N050810-001	AZASITE	1%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2007-04-27	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N050810-001	AZASITE	1%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2007-04-27	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N050810-001	AZASITE	1%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2007-04-27	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N050810-001	AZASITE	1%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2007-04-27	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N050810-001	AZASITE	1%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2007-04-27	`cb3db0bc1861…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N050810-001	6239113	2019-03-31	U-709		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N050810-001	6569443	2019-03-31	U-709	Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N050810-001	7056893	2019-03-31	U-709	Drug product	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	N050810-001	6239113	2019-03-31	U-709		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N050810-001	6569443	2019-03-31	U-709	Drug product	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N050810-001	7056893	2019-03-31	U-709	Drug product	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N050810-001	6239113	2019-03-31	U-709		`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N050810-001	6569443	2019-03-31	U-709	Drug product	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N050810-001	7056893	2019-03-31	U-709	Drug product	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N050810-001	6239113	2019-03-31	U-709		`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N050810-001	6569443	2019-03-31	U-709	Drug product	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N050810-001	7056893	2019-03-31	U-709	Drug product	`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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
AZASITE	AZITHROMYCIN MONOHYDRATE	Thea Pharma Inc.	0c5d6f5e-18ea-436f-8c62-bbaf66effe3d	2024-07-25	Warnings, Adverse reactions	Exact identifier application applno (NDA): 050810 application number: NDA050810 ndc (product): 82584-307

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
17478-307	AzaSITE	Azithromycin Monohydrate	Akorn	NDA	Current
17478-307	AzaSITE	Azithromycin Monohydrate	Akorn, Inc.	NDA	Current
17478-307	AzaSITE	Azithromycin Monohydrate	Akorn, Inc.	NDA	Current
17478-307	AzaSITE	Azithromycin Monohydrate	Akorn, Inc.	NDA	Current
82584-307	AZASITE	azithromycin monohydrate	Thea Pharma Inc.	NDA	Current
82584-307	AZASITE	azithromycin monohydrate	Thea Pharma Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
79243	SUPPL	2024-07-29
79218	SUPPL	2024-07-26
70152	SUPPL	2022-02-14
69345	SUPPL	2021-11-18
22249	SUPPL	2013-02-27
18293	SUPPL	2012-10-17
39379	SUPPL	2012-07-10
8332	SUPPL	2012-07-09
30602	SUPPL	2011-04-04
39378	SUPPL	2011-04-01
22248	ORIG	2009-08-13
30601	SUPPL	2009-05-11
8331	SUPPL	2009-05-11
8330	SUPPL	2009-05-11
39377	ORIG	2007-05-01
30600	ORIG	2007-05-01