Application 019216

Type: NDA
Sponsor: ALLERGAN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	FML FORTE	FLUOROMETHOLONE	SUSPENSION/DROPS;OPHTHALMIC	0.25%	Yes	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
N019216-001	FML FORTE	FLUOROMETHOLONE	0.25%	SUSPENSION/DROPS / OPHTHALMIC		RLD, RS	1986-04-23

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	N019216-001	FML FORTE	0.25%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	1986-04-23	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N019216-001	FML FORTE	0.25%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	1986-04-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019216-001	FML FORTE	0.25%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	1986-04-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019216-001	FML FORTE	0.25%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	1986-04-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019216-001	FML FORTE	0.25%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	1986-04-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019216-001	FML FORTE	0.25%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	1986-04-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019216-001	FML FORTE	0.25%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	1986-04-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019216-001	FML FORTE	0.25%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	1986-04-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019216-001	FML FORTE	0.25%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	1986-04-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019216-001	FML FORTE	0.25%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	1986-04-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N019216-001	FML FORTE	0.25%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	1986-04-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019216-001	FML FORTE	0.25%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	1986-04-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019216-001	FML FORTE	0.25%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	1986-04-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019216-001	FML FORTE	0.25%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	1986-04-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N019216-001	FML FORTE	0.25%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	1986-04-23	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019216-001	FML FORTE	0.25%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	1986-04-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N019216-001	FML FORTE	0.25%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	1986-04-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N019216-001	FML FORTE	0.25%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	1986-04-23	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N019216-001	FML FORTE	0.25%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	1986-04-23	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N019216-001	FML FORTE	0.25%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	1986-04-23	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N019216-001	FML FORTE	0.25%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	1986-04-23	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N019216-001	FML FORTE	0.25%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	1986-04-23	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N019216-001	FML FORTE	0.25%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	1986-04-23	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N019216-001	FML FORTE	0.25%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	1986-04-23	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N019216-001	FML FORTE	0.25%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	1986-04-23	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N019216-001	FML FORTE	0.25%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	1986-04-23	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N019216-001	FML FORTE	0.25%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	1986-04-23	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N019216-001	FML FORTE	0.25%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	1986-04-23	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N019216-001	FML FORTE	0.25%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	1986-04-23	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N019216-001	FML FORTE	0.25%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	1986-04-23	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N019216-001	FML FORTE	0.25%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	1986-04-23	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N019216-001	FML FORTE	0.25%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	1986-04-23	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N019216-001	FML FORTE	0.25%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	1986-04-23	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N019216-001	FML FORTE	0.25%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	1986-04-23	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N019216-001	FML FORTE	0.25%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	1986-04-23	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N019216-001	FML FORTE	0.25%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	1986-04-23	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N019216-001	FML FORTE	0.25%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	1986-04-23	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N019216-001	FML FORTE	0.25%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	1986-04-23	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N019216-001	FML FORTE	0.25%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	1986-04-23	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N019216-001	FML FORTE	0.25%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	1986-04-23	`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
FML FORTE	FLUOROMETHOLONE	Allergan, Inc.	b810b4c3-ac7a-4ba5-85bf-ebfaf3b1dabf	2025-02-13	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019216 application number: NDA019216 ndc (product): 11980-228

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
11980-228	FML FORTE	fluorometholone	Allergan, Inc.	NDA	Current
11980-228	FML FORTE	fluorometholone	Allergan, Inc.	NDA	Current
11980-228	FML FORTE	fluorometholone	Allergan, Inc.	NDA	Current
11980-228	FML FORTE	fluorometholone	Allergan, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
81262	SUPPL	2025-02-18
81261	SUPPL	2025-02-14
33708	SUPPL	2013-02-14
16216	SUPPL	2013-02-13
16215	SUPPL	2006-01-20
1253	SUPPL	2006-01-20
33707	SUPPL	2006-01-13
11453	SUPPL	2006-01-13