Application 017011

Type: NDA
Sponsor: ALLERGAN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PRED FORTE	PREDNISOLONE ACETATE	SUSPENSION/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
N017011-001	PRED FORTE	PREDNISOLONE ACETATE	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS, Approved before 1982

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
N017011-001	AB

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	Product TE source text	RLD / RS	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N017011-001	PRED FORTE	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017011-001	PRED FORTE	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N017011-001	PRED FORTE	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017011-001	PRED FORTE	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017011-001	PRED FORTE	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017011-001	PRED FORTE	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017011-001	PRED FORTE	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS, Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017011-001	PRED FORTE	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N017011-001	PRED FORTE	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS, Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N017011-001	PRED FORTE	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS, Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N017011-001	PRED FORTE	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N017011-001	PRED FORTE	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N017011-001	PRED FORTE	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS, Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N017011-001	PRED FORTE	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS, Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N017011-001	PRED FORTE	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS, Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N017011-001	PRED FORTE	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS, Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N017011-001	PRED FORTE	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS, Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N017011-001	PRED FORTE	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS, Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N017011-001	PRED FORTE	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS, Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N017011-001	PRED FORTE	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS, Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N017011-001	PRED FORTE	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS, Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N017011-001	PRED FORTE	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS, Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N017011-001	PRED FORTE	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS, Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N017011-001	PRED FORTE	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS, Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N017011-001	PRED FORTE	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS, Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N017011-001	PRED FORTE	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS, Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N017011-001	PRED FORTE	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS, Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N017011-001	PRED FORTE	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS, Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N017011-001	PRED FORTE	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS, Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N017011-001	PRED FORTE	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS, Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N017011-001	PRED FORTE	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS, Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N017011-001	PRED FORTE	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS, Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N017011-001	PRED FORTE	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS, Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N017011-001	PRED FORTE	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS, Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N017011-001	PRED FORTE	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS, Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N017011-001	PRED FORTE	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS, Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N017011-001	PRED FORTE	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS, Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N017011-001	PRED FORTE	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS, Approved before 1982	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N017011-001	PRED FORTE	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS, Approved before 1982	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N017011-001	PRED FORTE	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS, Approved before 1982	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N017011-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017011-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N017011-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017011-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017011-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017011-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017011-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017011-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N017011-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N017011-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N017011-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N017011-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N017011-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N017011-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N017011-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N017011-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N017011-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N017011-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N017011-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N017011-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N017011-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N017011-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N017011-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N017011-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N017011-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N017011-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N017011-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N017011-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N017011-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N017011-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N017011-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N017011-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N017011-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N017011-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N017011-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N017011-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N017011-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N017011-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N017011-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N017011-001	AB	1	`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 · 7 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	Exact identifier application applno (NDA): 017011 application number: NDA017011 ndc (product): 50090-5275
PREDNISOLONE ACETATE	PREDNISOLONE ACETATE	Sportpharm LLC	02fc6f0b-d053-49e1-82de-f272dd05d529	2026-04-24	Warnings, Adverse reactions	Exact identifier application applno (NDA): 017011 application number: NDA017011
PREDNISOLONE ACETATE	PREDNISOLONE ACETATE	A-S Medication Solutions	388abc87-cd5a-4e88-8675-7bf0c5ce7af5	2024-10-14	Warnings, Adverse reactions	Exact identifier application applno (NDA): 017011 application number: NDA017011 ndc (product): 50090-1912
PREDNISOLONE ACETATE	PREDNISOLONE ACETATE	NuCare Pharmaceuticals,Inc.	ab72cf3d-7660-41b1-e053-2995a90a7f44	2024-07-17	Warnings, Adverse reactions	Exact identifier application applno (NDA): 017011 application number: NDA017011 ndc (product): 68071-2222
PREDNISOLONE ACETATE	PREDNISOLONE ACETATE	Pacific Pharma, Inc.	1474d1df-70b6-4b1e-86d1-3349aa6d42fb	2024-03-19	Warnings, Adverse reactions	Exact identifier application applno (NDA): 017011 application number: NDA017011 ndc (product): 60758-119
PRED FORTE	PREDNISOLONE ACETATE	Allergan, Inc.	00a5aa88-e361-4ea7-8922-530c738b726e	2024-02-02	Warnings, Adverse reactions	Exact identifier application applno (NDA): 017011 application number: NDA017011 ndc (product): 11980-180
PREDNISOLONE ACETATE	PREDNISOLONE ACETATE	Asclemed USA, Inc.	232e40a5-17c5-4cf3-9e3b-110a194ad4be	2021-11-30	Warnings, Adverse reactions	Exact identifier application applno (NDA): 017011 application number: NDA017011 ndc (product): 76420-204

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 14 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
11980-180	PRED FORTE	prednisolone acetate	Allergan, Inc.	NDA	Current
11980-180	PRED FORTE	prednisolone acetate	Allergan, Inc.	NDA	Current
11980-180	PRED FORTE	prednisolone acetate	Allergan, Inc.	NDA	Current
11980-180	PRED FORTE	prednisolone acetate	Allergan, Inc.	NDA	Current
11980-180	PRED FORTE	prednisolone acetate	Allergan, Inc.	NDA	Current
50090-1912	PREDNISOLONE ACETATE	prednisolone acetate	A-S Medication Solutions	NDA AUTHORIZED GENERIC	Current
50090-5275	PREDNISOLONE ACETATE	prednisolone acetate	A-S Medication Solutions	NDA AUTHORIZED GENERIC	Current
52959-265	PREDNISOLONE ACETATE	prednisolone acetate	H.J. Harkins Company, Inc.	NDA AUTHORIZED GENERIC	Current
60758-119	PREDNISOLONE ACETATE	prednisolone acetate	Pacific Pharma, Inc.	NDA AUTHORIZED GENERIC	Current
60758-119	PREDNISOLONE ACETATE	prednisolone acetate	Pacific Pharma, Inc.	NDA AUTHORIZED GENERIC	Current
68071-1722	PREDNISOLONE ACETATE	prednisolone acetate	NuCare Pharmaceuticals,Inc.	NDA AUTHORIZED GENERIC	Current
68071-2222	PREDNISOLONE ACETATE	prednisolone acetate	NuCare Pharmaceuticals,Inc.	NDA AUTHORIZED GENERIC	Current
68071-2222	PREDNISOLONE ACETATE	prednisolone acetate	NuCare Pharmaceuticals,Inc.	NDA AUTHORIZED GENERIC	Current
76420-204	PREDNISOLONE ACETATE	prednisolone acetate	Asclemed USA, Inc.	NDA AUTHORIZED GENERIC	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
54557	SUPPL	2018-06-14
54492	SUPPL	2018-06-11
48301	SUPPL	2017-05-09
48267	SUPPL	2017-05-08