Application 022067

Type: NDA
Sponsor: TARO

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	FLO-PRED	PREDNISOLONE ACETATE	SUSPENSION;ORAL	EQ 5MG BASE/5ML	No	No
002	FLO-PRED	PREDNISOLONE ACETATE	SUSPENSION;ORAL	EQ 15MG BASE/5ML	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N022067-001	FLO-PRED	PREDNISOLONE ACETATE	EQ 5MG BASE/5ML	SUSPENSION / ORAL			2008-01-17
N022067-002	FLO-PRED	PREDNISOLONE ACETATE	EQ 15MG BASE/5ML	SUSPENSION / ORAL			2008-01-17

Orange Book patents#

Current patent rows page 1 of 1 · 4 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N022067-001	7799331	2028-10-11	U-1068	Drug product	2012-04-16
N022067-001	7799331	2028-10-11	U-139	Drug product	2012-04-16
N022067-002	7799331	2028-10-11	U-1068	Drug product
N022067-002	7799331	2028-10-11	U-139	Drug product

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 3 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	N022067-001	FLO-PRED	EQ 5MG BASE/5ML	SUSPENSION / ORAL	2008-01-17	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N022067-002	FLO-PRED	EQ 15MG BASE/5ML	SUSPENSION / ORAL	2008-01-17	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N022067-001	FLO-PRED	EQ 5MG BASE/5ML	SUSPENSION / ORAL	2008-01-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022067-002	FLO-PRED	EQ 15MG BASE/5ML	SUSPENSION / ORAL	2008-01-17	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N022067-001	FLO-PRED	EQ 5MG BASE/5ML	SUSPENSION / ORAL	2008-01-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022067-002	FLO-PRED	EQ 15MG BASE/5ML	SUSPENSION / ORAL	2008-01-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022067-001	FLO-PRED	EQ 5MG BASE/5ML	SUSPENSION / ORAL	2008-01-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022067-002	FLO-PRED	EQ 15MG BASE/5ML	SUSPENSION / ORAL	2008-01-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022067-001	FLO-PRED	EQ 5MG BASE/5ML	SUSPENSION / ORAL	2008-01-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022067-002	FLO-PRED	EQ 15MG BASE/5ML	SUSPENSION / ORAL	2008-01-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022067-001	FLO-PRED	EQ 5MG BASE/5ML	SUSPENSION / ORAL	2008-01-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022067-002	FLO-PRED	EQ 15MG BASE/5ML	SUSPENSION / ORAL	2008-01-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022067-001	FLO-PRED	EQ 5MG BASE/5ML	SUSPENSION / ORAL	2008-01-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022067-002	FLO-PRED	EQ 15MG BASE/5ML	SUSPENSION / ORAL	2008-01-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022067-001	FLO-PRED	EQ 5MG BASE/5ML	SUSPENSION / ORAL	2008-01-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022067-002	FLO-PRED	EQ 15MG BASE/5ML	SUSPENSION / ORAL	2008-01-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022067-001	FLO-PRED	EQ 5MG BASE/5ML	SUSPENSION / ORAL	2008-01-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022067-002	FLO-PRED	EQ 15MG BASE/5ML	SUSPENSION / ORAL	2008-01-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022067-001	FLO-PRED	EQ 5MG BASE/5ML	SUSPENSION / ORAL	2008-01-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022067-002	FLO-PRED	EQ 15MG BASE/5ML	SUSPENSION / ORAL	2008-01-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022067-001	FLO-PRED	EQ 5MG BASE/5ML	SUSPENSION / ORAL	2008-01-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022067-002	FLO-PRED	EQ 15MG BASE/5ML	SUSPENSION / ORAL	2008-01-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022067-001	FLO-PRED	EQ 5MG BASE/5ML	SUSPENSION / ORAL	2008-01-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022067-002	FLO-PRED	EQ 15MG BASE/5ML	SUSPENSION / ORAL	2008-01-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022067-001	FLO-PRED	EQ 5MG BASE/5ML	SUSPENSION / ORAL	2008-01-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022067-002	FLO-PRED	EQ 15MG BASE/5ML	SUSPENSION / ORAL	2008-01-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022067-001	FLO-PRED	EQ 5MG BASE/5ML	SUSPENSION / ORAL	2008-01-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022067-002	FLO-PRED	EQ 15MG BASE/5ML	SUSPENSION / ORAL	2008-01-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022067-001	FLO-PRED	EQ 5MG BASE/5ML	SUSPENSION / ORAL	2008-01-17	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022067-002	FLO-PRED	EQ 15MG BASE/5ML	SUSPENSION / ORAL	2008-01-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022067-001	FLO-PRED	EQ 5MG BASE/5ML	SUSPENSION / ORAL	2008-01-17	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022067-002	FLO-PRED	EQ 15MG BASE/5ML	SUSPENSION / ORAL	2008-01-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022067-001	FLO-PRED	EQ 5MG BASE/5ML	SUSPENSION / ORAL	2008-01-17	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N022067-002	FLO-PRED	EQ 15MG BASE/5ML	SUSPENSION / ORAL	2008-01-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022067-001	FLO-PRED	EQ 5MG BASE/5ML	SUSPENSION / ORAL	2008-01-17	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022067-002	FLO-PRED	EQ 15MG BASE/5ML	SUSPENSION / ORAL	2008-01-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022067-001	FLO-PRED	EQ 5MG BASE/5ML	SUSPENSION / ORAL	2008-01-17	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022067-002	FLO-PRED	EQ 15MG BASE/5ML	SUSPENSION / ORAL	2008-01-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022067-001	FLO-PRED	EQ 5MG BASE/5ML	SUSPENSION / ORAL	2008-01-17	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022067-002	FLO-PRED	EQ 15MG BASE/5ML	SUSPENSION / ORAL	2008-01-17	`4b0b4de00fa7…`

Observed Orange Book patent history#

Patent history page 2 of 5 · 176 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022067-001	7799331	2028-10-11	U-1068	Drug product	2012-04-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022067-001	7799331	2028-10-11	U-139	Drug product	2012-04-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022067-002	7799331	2028-10-11	U-139	Drug product		`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022067-002	7799331	2028-10-11	U-1068	Drug product		`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022067-001	7799331	2028-10-11	U-1068	Drug product	2012-04-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022067-001	7799331	2028-10-11	U-139	Drug product	2012-04-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022067-002	7799331	2028-10-11	U-139	Drug product		`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022067-002	7799331	2028-10-11	U-1068	Drug product		`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022067-001	7799331	2028-10-11	U-1068	Drug product	2012-04-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022067-001	7799331	2028-10-11	U-139	Drug product	2012-04-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022067-002	7799331	2028-10-11	U-139	Drug product		`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022067-002	7799331	2028-10-11	U-1068	Drug product		`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022067-001	7799331	2028-10-11	U-1068	Drug product	2012-04-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022067-001	7799331	2028-10-11	U-139	Drug product	2012-04-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022067-002	7799331	2028-10-11	U-139	Drug product		`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022067-002	7799331	2028-10-11	U-1068	Drug product		`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022067-001	7799331	2028-10-11	U-1068	Drug product	2012-04-16	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022067-001	7799331	2028-10-11	U-139	Drug product	2012-04-16	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022067-002	7799331	2028-10-11	U-139	Drug product		`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022067-002	7799331	2028-10-11	U-1068	Drug product		`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022067-001	7799331	2028-10-11	U-1068	Drug product	2012-04-16	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022067-001	7799331	2028-10-11	U-139	Drug product	2012-04-16	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022067-002	7799331	2028-10-11	U-139	Drug product		`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022067-002	7799331	2028-10-11	U-1068	Drug product		`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022067-001	7799331	2028-10-11	U-1068	Drug product	2012-04-16	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N022067-001	7799331	2028-10-11	U-139	Drug product	2012-04-16	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N022067-002	7799331	2028-10-11	U-139	Drug product		`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N022067-002	7799331	2028-10-11	U-1068	Drug product		`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022067-001	7799331	2028-10-11	U-1068	Drug product	2012-04-16	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022067-001	7799331	2028-10-11	U-139	Drug product	2012-04-16	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022067-002	7799331	2028-10-11	U-139	Drug product		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022067-002	7799331	2028-10-11	U-1068	Drug product		`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022067-001	7799331	2028-10-11	U-1068	Drug product	2012-04-16	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022067-001	7799331	2028-10-11	U-139	Drug product	2012-04-16	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022067-002	7799331	2028-10-11	U-139	Drug product		`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022067-002	7799331	2028-10-11	U-1068	Drug product		`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022067-001	7799331	2028-10-11	U-1068	Drug product	2012-04-16	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022067-001	7799331	2028-10-11	U-139	Drug product	2012-04-16	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022067-002	7799331	2028-10-11	U-139	Drug product		`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022067-002	7799331	2028-10-11	U-1068	Drug product		`4b0b4de00fa7…`

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 · 15 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
PREDNISOLONE ACETATE	PREDNISOLONE ACETATE	A-S Medication Solutions	dd32d625-fb2f-4c51-89fe-cdccdf0201b9	2026-08-03	Warnings, Adverse reactions	Name fallback generic name: PREDNISOLONE ACETATE
Prednisolone Acetate	PREDNISOLONE ACETATE	Sportpharm LLC	3011a244-24a4-46ef-979a-b5d9e7076246	2026-07-23	Warnings, Adverse reactions	Name fallback generic name: PREDNISOLONE ACETATE
PREDNISOLONE ACETATE	PREDNISOLONE ACETATE	Sportpharm LLC	02fc6f0b-d053-49e1-82de-f272dd05d529	2026-04-24	Warnings, Adverse reactions	Name fallback generic name: PREDNISOLONE ACETATE
PREDNISOLONE ACETATE	PREDNISOLONE ACETATE	A-S Medication Solutions	f0e1b691-73ff-49ee-8a3c-71769b284ab8	2026-03-03	Warnings, Adverse reactions	Name fallback generic name: PREDNISOLONE ACETATE
PREDNISOLONE ACETATE	PREDNISOLONE ACETATE	Redpharm Drug	3dd0195c-8522-bbf9-e063-6394a90a9f3e	2025-12-02	Warnings, Adverse reactions	Name fallback generic name: PREDNISOLONE ACETATE
PRED MILD	PREDNISOLONE ACETATE	Allergan, Inc.	4fcce64a-94ea-4031-ad5a-c4eddc73a910	2025-11-25	Warnings, Adverse reactions	Name fallback generic name: PREDNISOLONE ACETATE
PREDNISOLONE ACETATE	PREDNISOLONE ACETATE	Lupin Pharmaceuticals, Inc.	75fbeab1-ce8d-4999-a875-472174be5cc6	2025-10-13	Warnings, Adverse reactions	Name fallback generic name: PREDNISOLONE ACETATE
prednisolone acetate	PREDNISOLONE ACETATE	Amneal Pharmaceuticals NY LLC	8d8e8f9b-4d65-426f-8c57-451001cdd849	2025-06-12	Warnings, Adverse reactions	Name fallback generic name: PREDNISOLONE ACETATE
Prednisolone Acetate	PREDNISOLONE ACETATE	Sandoz Inc	05d205c7-8f51-46b9-a6c5-4199bc432b26	2024-12-30	Warnings, Adverse reactions	Name fallback generic name: PREDNISOLONE ACETATE
PREDNISOLONE ACETATE	PREDNISOLONE ACETATE	A-S Medication Solutions	388abc87-cd5a-4e88-8675-7bf0c5ce7af5	2024-10-14	Warnings, Adverse reactions	Name fallback generic name: PREDNISOLONE ACETATE
PREDNISOLONE ACETATE	PREDNISOLONE ACETATE	NuCare Pharmaceuticals,Inc.	ab72cf3d-7660-41b1-e053-2995a90a7f44	2024-07-17	Warnings, Adverse reactions	Name fallback generic name: PREDNISOLONE ACETATE
PREDNISOLONE ACETATE	PREDNISOLONE ACETATE	Pacific Pharma, Inc.	1474d1df-70b6-4b1e-86d1-3349aa6d42fb	2024-03-19	Warnings, Adverse reactions	Name fallback generic name: PREDNISOLONE ACETATE
PRED FORTE	PREDNISOLONE ACETATE	Allergan, Inc.	00a5aa88-e361-4ea7-8922-530c738b726e	2024-02-02	Warnings, Adverse reactions	Name fallback generic name: PREDNISOLONE ACETATE
Prednisolone Acetate	PREDNISOLONE ACETATE	A-S Medication Solutions	b1d30a4f-4941-45a5-bd24-fea07f1bfc87	2023-04-30	Warnings, Adverse reactions	Name fallback generic name: PREDNISOLONE ACETATE
PREDNISOLONE ACETATE	PREDNISOLONE ACETATE	Asclemed USA, Inc.	232e40a5-17c5-4cf3-9e3b-110a194ad4be	2021-11-30	Warnings, Adverse reactions	Name fallback generic name: PREDNISOLONE ACETATE

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
51672-1338	Flo-Pred	Prednisolone Acetate	Taro Pharmaceuticals U.S.A., Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
78720	SUPPL	2024-07-02
78683	SUPPL	2024-06-06
68137	SUPPL	2021-07-20
68109	SUPPL	2021-07-19
6813	SUPPL	2011-06-17
16883	SUPPL	2011-06-16
16882	SUPPL	2010-05-17
6812	SUPPL	2010-05-12
44673	ORIG	2010-02-24
42407	ORIG	2010-02-24
38178	SUPPL	2008-10-09
6811	SUPPL	2008-10-08
6810	SUPPL	2008-07-01
16881	SUPPL	2008-06-30
29188	ORIG	2008-01-23
16880	ORIG	2008-01-18