Application 040070

Type: ANDA
Sponsor: BAUSCH AND LOMB

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PREDNISOLONE SODIUM PHOSPHATE	PREDNISOLONE SODIUM PHOSPHATE	SOLUTION/DROPS;OPHTHALMIC	EQ 0.9% PHOSPHATE	No	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
A040070-001	PREDNISOLONE SODIUM PHOSPHATE	PREDNISOLONE SODIUM PHOSPHATE	EQ 0.9% PHOSPHATE	SOLUTION/DROPS / OPHTHALMIC		RS	1994-07-29

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	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A040070-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 0.9% PHOSPHATE	SOLUTION/DROPS / OPHTHALMIC	RS	1994-07-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040070-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 0.9% PHOSPHATE	SOLUTION/DROPS / OPHTHALMIC	RS	1994-07-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040070-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 0.9% PHOSPHATE	SOLUTION/DROPS / OPHTHALMIC	RS	1994-07-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040070-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 0.9% PHOSPHATE	SOLUTION/DROPS / OPHTHALMIC	RS	1994-07-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040070-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 0.9% PHOSPHATE	SOLUTION/DROPS / OPHTHALMIC	RS	1994-07-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040070-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 0.9% PHOSPHATE	SOLUTION/DROPS / OPHTHALMIC	RS	1994-07-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040070-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 0.9% PHOSPHATE	SOLUTION/DROPS / OPHTHALMIC	RS	1994-07-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040070-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 0.9% PHOSPHATE	SOLUTION/DROPS / OPHTHALMIC	RS	1994-07-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040070-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 0.9% PHOSPHATE	SOLUTION/DROPS / OPHTHALMIC	RS	1994-07-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040070-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 0.9% PHOSPHATE	SOLUTION/DROPS / OPHTHALMIC	RS	1994-07-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040070-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 0.9% PHOSPHATE	SOLUTION/DROPS / OPHTHALMIC	RS	1994-07-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040070-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 0.9% PHOSPHATE	SOLUTION/DROPS / OPHTHALMIC	RS	1994-07-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040070-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 0.9% PHOSPHATE	SOLUTION/DROPS / OPHTHALMIC	RS	1994-07-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040070-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 0.9% PHOSPHATE	SOLUTION/DROPS / OPHTHALMIC	RS	1994-07-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040070-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 0.9% PHOSPHATE	SOLUTION/DROPS / OPHTHALMIC	RS	1994-07-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040070-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 0.9% PHOSPHATE	SOLUTION/DROPS / OPHTHALMIC	RS	1994-07-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040070-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 0.9% PHOSPHATE	SOLUTION/DROPS / OPHTHALMIC	RS	1994-07-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040070-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 0.9% PHOSPHATE	SOLUTION/DROPS / OPHTHALMIC	RS	1994-07-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040070-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 0.9% PHOSPHATE	SOLUTION/DROPS / OPHTHALMIC	RS	1994-07-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040070-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 0.9% PHOSPHATE	SOLUTION/DROPS / OPHTHALMIC	RS	1994-07-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040070-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 0.9% PHOSPHATE	SOLUTION/DROPS / OPHTHALMIC	RS	1994-07-29	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040070-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 0.9% PHOSPHATE	SOLUTION/DROPS / OPHTHALMIC	RS	1994-07-29	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040070-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 0.9% PHOSPHATE	SOLUTION/DROPS / OPHTHALMIC	RS	1994-07-29	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040070-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 0.9% PHOSPHATE	SOLUTION/DROPS / OPHTHALMIC	RS	1994-07-29	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040070-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 0.9% PHOSPHATE	SOLUTION/DROPS / OPHTHALMIC	RS	1994-07-29	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040070-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 0.9% PHOSPHATE	SOLUTION/DROPS / OPHTHALMIC	RS	1994-07-29	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040070-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 0.9% PHOSPHATE	SOLUTION/DROPS / OPHTHALMIC	RS	1994-07-29	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040070-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 0.9% PHOSPHATE	SOLUTION/DROPS / OPHTHALMIC	RS	1994-07-29	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040070-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 0.9% PHOSPHATE	SOLUTION/DROPS / OPHTHALMIC	RS	1994-07-29	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040070-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 0.9% PHOSPHATE	SOLUTION/DROPS / OPHTHALMIC	RS	1994-07-29	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040070-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 0.9% PHOSPHATE	SOLUTION/DROPS / OPHTHALMIC	RS	1994-07-29	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040070-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 0.9% PHOSPHATE	SOLUTION/DROPS / OPHTHALMIC	RS	1994-07-29	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040070-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 0.9% PHOSPHATE	SOLUTION/DROPS / OPHTHALMIC	RS	1994-07-29	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040070-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 0.9% PHOSPHATE	SOLUTION/DROPS / OPHTHALMIC	RS	1994-07-29	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040070-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 0.9% PHOSPHATE	SOLUTION/DROPS / OPHTHALMIC	RS	1994-07-29	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040070-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 0.9% PHOSPHATE	SOLUTION/DROPS / OPHTHALMIC	RS	1994-07-29	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040070-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 0.9% PHOSPHATE	SOLUTION/DROPS / OPHTHALMIC	RS	1994-07-29	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040070-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 0.9% PHOSPHATE	SOLUTION/DROPS / OPHTHALMIC	RS	1994-07-29	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040070-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 0.9% PHOSPHATE	SOLUTION/DROPS / OPHTHALMIC	RS	1994-07-29	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040070-001	PREDNISOLONE SODIUM PHOSPHATE	EQ 0.9% PHOSPHATE	SOLUTION/DROPS / OPHTHALMIC	RS	1994-07-29	`e64feba35796…`

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
PREDNISOLONE SODIUM PHOSPHATE	PREDNISOLONE SODIUM PHOSPHATE	Bausch & Lomb Incorporated	8a7f0f2a-3a48-4488-89cd-3e91c3b1365f	2023-04-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040070 application number: ANDA040070 ndc (product): 24208-715

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
11695-1431	Prednisolone Sodium Phosphate	PREDNISOLONE SODIUM PHOSPHATE	Butler Animal Health Supply	ANDA	Current
13985-025	PREDNISOLONE SODIUM PHOSPHATE	PREDNISOLONE SODIUM PHOSPHATE	MWI/VetOne	ANDA	Current
24208-715	PREDNISOLONE SODIUM PHOSPHATE	PREDNISOLONE SODIUM PHOSPHATE	Bausch & Lomb Incorporated	ANDA	Current
24208-715	PREDNISOLONE SODIUM PHOSPHATE	PREDNISOLONE SODIUM PHOSPHATE	Bausch & Lomb Incorporated	ANDA	Current
24208-715	PREDNISOLONE SODIUM PHOSPHATE	PREDNISOLONE SODIUM PHOSPHATE	Bausch & Lomb Incorporated	ANDA	Current