Application 016851

Type: NDA
Sponsor: ALLERGAN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
002	FML	FLUOROMETHOLONE	SUSPENSION/DROPS;OPHTHALMIC	0.1%	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
N016851-002	FML	FLUOROMETHOLONE	0.1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1982-07-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N016851-002	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 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N016851-002	FML	0.1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1982-07-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N016851-002	FML	0.1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1982-07-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N016851-002	FML	0.1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1982-07-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N016851-002	FML	0.1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1982-07-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N016851-002	FML	0.1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1982-07-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N016851-002	FML	0.1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1982-07-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N016851-002	FML	0.1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1982-07-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N016851-002	FML	0.1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1982-07-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N016851-002	FML	0.1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1982-07-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N016851-002	FML	0.1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1982-07-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N016851-002	FML	0.1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1982-07-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N016851-002	FML	0.1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1982-07-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N016851-002	FML	0.1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1982-07-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N016851-002	FML	0.1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1982-07-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N016851-002	FML	0.1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1982-07-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N016851-002	FML	0.1%	SUSPENSION/DROPS / OPHTHALMIC		RLD, RS	1982-07-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N016851-002	FML	0.1%	SUSPENSION/DROPS / OPHTHALMIC		RLD, RS	1982-07-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N016851-002	FML	0.1%	SUSPENSION/DROPS / OPHTHALMIC		RLD, RS	1982-07-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N016851-002	FML	0.1%	SUSPENSION/DROPS / OPHTHALMIC		RLD, RS	1982-07-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N016851-002	FML	0.1%	SUSPENSION/DROPS / OPHTHALMIC		RLD, RS	1982-07-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N016851-002	FML	0.1%	SUSPENSION/DROPS / OPHTHALMIC		RLD, RS	1982-07-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N016851-002	FML	0.1%	SUSPENSION/DROPS / OPHTHALMIC		RLD, RS	1982-07-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N016851-002	FML	0.1%	SUSPENSION/DROPS / OPHTHALMIC		RLD, RS	1982-07-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N016851-002	FML	0.1%	SUSPENSION/DROPS / OPHTHALMIC		RLD, RS	1982-07-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N016851-002	FML	0.1%	SUSPENSION/DROPS / OPHTHALMIC		RLD, RS	1982-07-28	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N016851-002	FML	0.1%	SUSPENSION/DROPS / OPHTHALMIC		RLD, RS	1982-07-28	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N016851-002	FML	0.1%	SUSPENSION/DROPS / OPHTHALMIC		RLD, RS	1982-07-28	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N016851-002	FML	0.1%	SUSPENSION/DROPS / OPHTHALMIC		RLD, RS	1982-07-28	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N016851-002	FML	0.1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1982-07-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N016851-002	FML	0.1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1982-07-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N016851-002	FML	0.1%	SUSPENSION/DROPS / OPHTHALMIC		RLD, RS	1982-07-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N016851-002	FML	0.1%	SUSPENSION/DROPS / OPHTHALMIC		RLD, RS	1982-07-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N016851-002	FML	0.1%	SUSPENSION/DROPS / OPHTHALMIC		RLD, RS	1982-07-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N016851-002	FML	0.1%	SUSPENSION/DROPS / OPHTHALMIC		RLD, RS	1982-07-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N016851-002	FML	0.1%	SUSPENSION/DROPS / OPHTHALMIC		RLD, RS	1982-07-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N016851-002	FML	0.1%	SUSPENSION/DROPS / OPHTHALMIC		RLD, RS	1982-07-28	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N016851-002	FML	0.1%	SUSPENSION/DROPS / OPHTHALMIC		RLD, RS	1982-07-28	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N016851-002	FML	0.1%	SUSPENSION/DROPS / OPHTHALMIC		RLD, RS	1982-07-28	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N016851-002	FML	0.1%	SUSPENSION/DROPS / OPHTHALMIC		RLD, RS	1982-07-28	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N016851-002	FML	0.1%	SUSPENSION/DROPS / OPHTHALMIC		RLD, RS	1982-07-28	`e64feba35796…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	N016851-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N016851-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N016851-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N016851-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N016851-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N016851-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N016851-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N016851-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N016851-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N016851-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N016851-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N016851-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N016851-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N016851-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N016851-002	AB	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N016851-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N016851-002	AB	1	`1c564ffb4f44…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N016851-002	AB	1	`a50c72e98297…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
FML	FLUOROMETHOLONE	Allergan, Inc.	c374d65a-35b5-4c9e-9069-5148875dc4df	2023-12-01	Warnings, Adverse reactions	Exact identifier application applno (NDA): 016851 application number: NDA016851 ndc (product): 11980-211
FLUOROMETHOLONE	FLUOROMETHOLONE	Pacific Pharma, Inc.	af59c420-789d-4c05-b3fc-c3f855bcac24	2020-09-21	Warnings, Adverse reactions	Exact identifier application applno (NDA): 016851 application number: NDA016851 ndc (product): 60758-880

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
11980-211	FML	fluorometholone	Allergan, Inc.	NDA	Current
11980-211	FML	fluorometholone	Allergan, Inc.	NDA	Current
11980-211	FML	fluorometholone	Allergan, Inc.	NDA	Current
60758-880	FLUOROMETHOLONE	fluorometholone	Pacific Pharma, Inc.	NDA AUTHORIZED GENERIC	Current
60758-880	FLUOROMETHOLONE	fluorometholone	Pacific Pharma, Inc.	NDA AUTHORIZED GENERIC	Current
60758-880	FLUOROMETHOLONE	fluorometholone	Pacific Pharma, Inc.	NDA AUTHORIZED GENERIC	Current
60758-880	FLUOROMETHOLONE	fluorometholone	Pacific Pharma, Inc.	NDA AUTHORIZED GENERIC	Current
70518-1929	FLUOROMETHOLONE	fluorometholone	REMEDYREPACK INC.	NDA AUTHORIZED GENERIC	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
10928	SUPPL	2013-02-14
504	SUPPL	2013-02-13
10927	SUPPL	2003-06-16
13043	SUPPL	2001-06-28