Application 012787

Type: NDA
Sponsor: MEDIMETRIKS PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
002	SYNALAR	FLUOCINOLONE ACETONIDE	CREAM;TOPICAL	0.025%	Yes	Yes
004	SYNALAR	FLUOCINOLONE ACETONIDE	CREAM;TOPICAL	0.01%	Yes	Yes
005	SYNALAR	FLUOCINOLONE ACETONIDE	CREAM;TOPICAL	0.025%	Yes	Yes

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS
N012787-002	SYNALAR	FLUOCINOLONE ACETONIDE	0.025%	CREAM / TOPICAL	AT	RLD, RS, Approved before 1982
N012787-004	SYNALAR	FLUOCINOLONE ACETONIDE	0.01%	CREAM / TOPICAL	AT	RLD, RS, Approved before 1982
N012787-005	SYNALAR	FLUOCINOLONE ACETONIDE	0.025%	CREAM / TOPICAL	AT	RLD, RS, Approved before 1982

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
N012787-002	AT
N012787-004	AT
N012787-005	AT

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 3 of 4 · 132 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
2020-11-12 02:37 UTC	2020-11	N012787-005	SYNALAR	0.025%	CREAM / TOPICAL	AT	RLD, RS, Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N012787-002	SYNALAR	0.025%	CREAM / TOPICAL	AT	RLD, RS, Approved before 1982	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N012787-004	SYNALAR	0.01%	CREAM / TOPICAL	AT	RLD, RS, Approved before 1982	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N012787-005	SYNALAR	0.025%	CREAM / TOPICAL	AT	RLD, RS, Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N012787-002	SYNALAR	0.025%	CREAM / TOPICAL	AT	RLD, RS, Approved before 1982	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N012787-004	SYNALAR	0.01%	CREAM / TOPICAL	AT	RLD, RS, Approved before 1982	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N012787-005	SYNALAR	0.025%	CREAM / TOPICAL	AT	RLD, RS, Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N012787-002	SYNALAR	0.025%	CREAM / TOPICAL	AT	RLD, RS, Approved before 1982	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N012787-004	SYNALAR	0.01%	CREAM / TOPICAL	AT	RLD, RS, Approved before 1982	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N012787-005	SYNALAR	0.025%	CREAM / TOPICAL	AT	RLD, RS, Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N012787-002	SYNALAR	0.025%	CREAM / TOPICAL	AT	RLD, RS, Approved before 1982	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N012787-004	SYNALAR	0.01%	CREAM / TOPICAL	AT	RLD, RS, Approved before 1982	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N012787-005	SYNALAR	0.025%	CREAM / TOPICAL	AT	RLD, RS, Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N012787-002	SYNALAR	0.025%	CREAM / TOPICAL	AT	RLD, RS, Approved before 1982	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N012787-004	SYNALAR	0.01%	CREAM / TOPICAL	AT	RLD, RS, Approved before 1982	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N012787-005	SYNALAR	0.025%	CREAM / TOPICAL	AT	RLD, RS, Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N012787-002	SYNALAR	0.025%	CREAM / TOPICAL	AT	RLD, RS, Approved before 1982	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N012787-004	SYNALAR	0.01%	CREAM / TOPICAL	AT	RLD, RS, Approved before 1982	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N012787-005	SYNALAR	0.025%	CREAM / TOPICAL	AT	RLD, RS, Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N012787-002	SYNALAR	0.025%	CREAM / TOPICAL	AT	RLD, RS, Approved before 1982	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N012787-004	SYNALAR	0.01%	CREAM / TOPICAL	AT	RLD, RS, Approved before 1982	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N012787-005	SYNALAR	0.025%	CREAM / TOPICAL	AT	RLD, RS, Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N012787-002	SYNALAR	0.025%	CREAM / TOPICAL	AT	RLD, RS, Approved before 1982	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N012787-004	SYNALAR	0.01%	CREAM / TOPICAL	AT	RLD, RS, Approved before 1982	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N012787-005	SYNALAR	0.025%	CREAM / TOPICAL	AT	RLD, RS, Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N012787-002	SYNALAR	0.025%	CREAM / TOPICAL	AT	RLD, RS, Approved before 1982	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N012787-004	SYNALAR	0.01%	CREAM / TOPICAL	AT	RLD, RS, Approved before 1982	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N012787-005	SYNALAR	0.025%	CREAM / TOPICAL	AT	RLD, RS, Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N012787-002	SYNALAR	0.025%	CREAM / TOPICAL	AT	RLD, RS, Approved before 1982	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N012787-004	SYNALAR	0.01%	CREAM / TOPICAL	AT	RLD, RS, Approved before 1982	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N012787-005	SYNALAR	0.025%	CREAM / TOPICAL	AT	RLD, RS, Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N012787-002	SYNALAR	0.025%	CREAM / TOPICAL	AT	RLD, RS, Approved before 1982	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N012787-004	SYNALAR	0.01%	CREAM / TOPICAL	AT	RLD, RS, Approved before 1982	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N012787-005	SYNALAR	0.025%	CREAM / TOPICAL	AT	RLD, RS, Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N012787-002	SYNALAR	0.025%	CREAM / TOPICAL	AT	RLD, RS, Approved before 1982	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N012787-004	SYNALAR	0.01%	CREAM / TOPICAL	AT	RLD, RS, Approved before 1982	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N012787-005	SYNALAR	0.025%	CREAM / TOPICAL	AT	RLD, RS, Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N012787-002	SYNALAR	0.025%	CREAM / TOPICAL	AT	RLD, RS, Approved before 1982	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N012787-004	SYNALAR	0.01%	CREAM / TOPICAL	AT	RLD, RS, Approved before 1982	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N012787-005	SYNALAR	0.025%	CREAM / TOPICAL	AT	RLD, RS, Approved before 1982	`3a93d1ddd44b…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 132 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	N012787-002	AT	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N012787-004	AT	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N012787-005	AT	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N012787-002	AT	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N012787-004	AT	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N012787-005	AT	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N012787-002	AT	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N012787-004	AT	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N012787-005	AT	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N012787-002	AT	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N012787-004	AT	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N012787-005	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N012787-002	AT	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N012787-004	AT	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N012787-005	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N012787-002	AT	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N012787-004	AT	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N012787-005	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N012787-002	AT	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N012787-004	AT	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N012787-005	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N012787-002	AT	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N012787-004	AT	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N012787-005	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N012787-002	AT	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N012787-004	AT	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N012787-005	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N012787-002	AT	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N012787-004	AT	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N012787-005	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N012787-002	AT	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N012787-004	AT	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N012787-005	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N012787-002	AT	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N012787-004	AT	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N012787-005	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N012787-002	AT	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N012787-004	AT	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N012787-005	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N012787-002	AT	1	`79d66fd596c7…`

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
fluocinolone acetonide	FLUOCINOLONE ACETONIDE	ANI Pharmaceuticals, Inc.	50e7006d-a51b-49aa-8e1c-330340e7bf82	2026-02-23	Adverse reactions	Exact identifier application applno (NDA): 012787 application number: NDA012787
Synalar	FLUOCINOLONE ACETONIDE	Medimetriks Pharmaceuticals, Inc.	5af2e4c1-082b-48a0-aae7-72d4a68cbb2d	2024-07-18	Adverse reactions	Exact identifier application applno (NDA): 012787 application number: NDA012787 ndc (product): 43538-900

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 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0713-0324	Fluocinolone Acetonide	Fluocinolone Acetonide	Cosette Pharmaceuticals, Inc.	NDA	Current
43538-900	Synalar	fluocinolone acetonide	Medimetriks Pharmaceuticals, Inc.	NDA	Current
43538-901	Synalar	Fluocinolone acetonide	Medimetriks Pharmaceuticals, Inc.	NDA	Current
52565-020	Fluocinolone Acetonide	Fluocinolone Acetonide	Teligent Pharma, Inc.	NDA AUTHORIZED GENERIC	Current
52565-031	Fluocinolone Acetonide	Fluocinolone Acetonide	Teligent Pharma, Inc.	NDA AUTHORIZED GENERIC	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
10823	SUPPL	2013-04-09
10822	SUPPL	2013-04-01