Application 040069

Type: ANDA
Sponsor: BAUSCH AND LOMB

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DEXAMETHASONE SODIUM PHOSPHATE	DEXAMETHASONE SODIUM PHOSPHATE	SOLUTION/DROPS;OPHTHALMIC, OTIC	EQ 0.1% PHOSPHATE	No	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
A040069-001	DEXAMETHASONE SODIUM PHOSPHATE	DEXAMETHASONE SODIUM PHOSPHATE	EQ 0.1% PHOSPHATE	SOLUTION/DROPS / OPHTHALMIC, OTIC		RS	1996-07-26

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	A040069-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 0.1% PHOSPHATE	SOLUTION/DROPS / OPHTHALMIC, OTIC	RS	1996-07-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040069-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 0.1% PHOSPHATE	SOLUTION/DROPS / OPHTHALMIC, OTIC	RS	1996-07-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040069-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 0.1% PHOSPHATE	SOLUTION/DROPS / OPHTHALMIC, OTIC	RS	1996-07-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040069-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 0.1% PHOSPHATE	SOLUTION/DROPS / OPHTHALMIC, OTIC	RS	1996-07-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040069-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 0.1% PHOSPHATE	SOLUTION/DROPS / OPHTHALMIC, OTIC	RS	1996-07-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040069-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 0.1% PHOSPHATE	SOLUTION/DROPS / OPHTHALMIC, OTIC	RS	1996-07-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040069-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 0.1% PHOSPHATE	SOLUTION/DROPS / OPHTHALMIC, OTIC	RS	1996-07-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040069-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 0.1% PHOSPHATE	SOLUTION/DROPS / OPHTHALMIC, OTIC	RS	1996-07-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040069-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 0.1% PHOSPHATE	SOLUTION/DROPS / OPHTHALMIC, OTIC	RS	1996-07-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040069-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 0.1% PHOSPHATE	SOLUTION/DROPS / OPHTHALMIC, OTIC	RS	1996-07-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040069-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 0.1% PHOSPHATE	SOLUTION/DROPS / OPHTHALMIC, OTIC	RS	1996-07-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040069-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 0.1% PHOSPHATE	SOLUTION/DROPS / OPHTHALMIC, OTIC	RS	1996-07-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040069-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 0.1% PHOSPHATE	SOLUTION/DROPS / OPHTHALMIC, OTIC	RS	1996-07-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040069-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 0.1% PHOSPHATE	SOLUTION/DROPS / OPHTHALMIC, OTIC	RS	1996-07-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040069-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 0.1% PHOSPHATE	SOLUTION/DROPS / OPHTHALMIC, OTIC	RS	1996-07-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040069-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 0.1% PHOSPHATE	SOLUTION/DROPS / OPHTHALMIC, OTIC	RS	1996-07-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040069-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 0.1% PHOSPHATE	SOLUTION/DROPS / OPHTHALMIC, OTIC	RS	1996-07-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040069-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 0.1% PHOSPHATE	SOLUTION/DROPS / OPHTHALMIC, OTIC	RS	1996-07-26	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040069-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 0.1% PHOSPHATE	SOLUTION/DROPS / OPHTHALMIC, OTIC	RS	1996-07-26	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040069-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 0.1% PHOSPHATE	SOLUTION/DROPS / OPHTHALMIC, OTIC	RS	1996-07-26	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040069-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 0.1% PHOSPHATE	SOLUTION/DROPS / OPHTHALMIC, OTIC	RS	1996-07-26	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040069-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 0.1% PHOSPHATE	SOLUTION/DROPS / OPHTHALMIC, OTIC	RS	1996-07-26	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040069-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 0.1% PHOSPHATE	SOLUTION/DROPS / OPHTHALMIC, OTIC	RS	1996-07-26	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040069-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 0.1% PHOSPHATE	SOLUTION/DROPS / OPHTHALMIC, OTIC	RS	1996-07-26	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040069-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 0.1% PHOSPHATE	SOLUTION/DROPS / OPHTHALMIC, OTIC	RS	1996-07-26	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040069-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 0.1% PHOSPHATE	SOLUTION/DROPS / OPHTHALMIC, OTIC	RS	1996-07-26	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040069-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 0.1% PHOSPHATE	SOLUTION/DROPS / OPHTHALMIC, OTIC	RS	1996-07-26	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040069-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 0.1% PHOSPHATE	SOLUTION/DROPS / OPHTHALMIC, OTIC	RS	1996-07-26	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040069-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 0.1% PHOSPHATE	SOLUTION/DROPS / OPHTHALMIC, OTIC	RS	1996-07-26	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040069-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 0.1% PHOSPHATE	SOLUTION/DROPS / OPHTHALMIC, OTIC	RS	1996-07-26	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040069-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 0.1% PHOSPHATE	SOLUTION/DROPS / OPHTHALMIC, OTIC	RS	1996-07-26	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040069-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 0.1% PHOSPHATE	SOLUTION/DROPS / OPHTHALMIC, OTIC	RS	1996-07-26	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040069-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 0.1% PHOSPHATE	SOLUTION/DROPS / OPHTHALMIC, OTIC	RS	1996-07-26	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040069-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 0.1% PHOSPHATE	SOLUTION/DROPS / OPHTHALMIC, OTIC	RS	1996-07-26	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040069-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 0.1% PHOSPHATE	SOLUTION/DROPS / OPHTHALMIC, OTIC	RS	1996-07-26	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040069-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 0.1% PHOSPHATE	SOLUTION/DROPS / OPHTHALMIC, OTIC	RS	1996-07-26	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040069-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 0.1% PHOSPHATE	SOLUTION/DROPS / OPHTHALMIC, OTIC	RS	1996-07-26	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040069-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 0.1% PHOSPHATE	SOLUTION/DROPS / OPHTHALMIC, OTIC	RS	1996-07-26	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040069-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 0.1% PHOSPHATE	SOLUTION/DROPS / OPHTHALMIC, OTIC	RS	1996-07-26	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A040069-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 0.1% PHOSPHATE	SOLUTION/DROPS / OPHTHALMIC, OTIC	RS	1996-07-26	`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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dexamethasone Sodium Phosphate	DEXAMETHASONE SODIUM PHOSPHATE	Bausch & Lomb Incorporated	6bdcefbe-51e3-4ca4-afda-5aeca7b6fa73	2022-08-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040069 application number: ANDA040069 ndc (product): 24208-720

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 12 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
11695-1411	Dexamethasone Sodium Phosphate	Dexamethasone Sodium Phosphate	Butler Animal Health Supply	ANDA	Current
24208-720	Dexamethasone Sodium Phosphate	Dexamethasone Sodium Phosphate	Bausch & Lomb Incorporated	ANDA	Current
24208-720	Dexamethasone Sodium Phosphate	Dexamethasone Sodium Phosphate	Bausch & Lomb Incorporated	ANDA	Current
24208-720	Dexamethasone Sodium Phosphate	Dexamethasone Sodium Phosphate	Bausch & Lomb Incorporated	ANDA	Current
42254-088	Dexamethasone Sodium Phosphate	Dexamethasone Sodium Phosphate	Rebel Distributors Corp	ANDA	Current
57319-065	Dexamethasone Sodium Phosphate	Dexamethasone Sodium Phosphate	Phoenix Pharmaceutical, Inc.	ANDA	Current
70518-0410	Dexamethasone Sodium Phosphate	Dexamethasone Sodium Phosphate	REMEDYREPACK INC.	ANDA	Current
70518-0410	Dexamethasone Sodium Phosphate	Dexamethasone Sodium Phosphate	REMEDYREPACK INC.	ANDA	Current
70518-0410	Dexamethasone Sodium Phosphate	Dexamethasone Sodium Phosphate	REMEDYREPACK INC.	ANDA	Current
70518-0410	Dexamethasone Sodium Phosphate	Dexamethasone Sodium Phosphate	REMEDYREPACK INC.	ANDA	Current
70518-0410	Dexamethasone Sodium Phosphate	Dexamethasone Sodium Phosphate	REMEDYREPACK INC.	ANDA	Current
70518-0410	Dexamethasone Sodium Phosphate	Dexamethasone Sodium Phosphate	REMEDYREPACK INC.	ANDA	Current