Application 208079

Type: NDA
Sponsor: ENCORE DERMAT

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	SERNIVO	BETAMETHASONE DIPROPIONATE	SPRAY;TOPICAL	EQ 0.05% BASE/SPRAY	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
N208079-001	SERNIVO	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE/SPRAY	SPRAY / TOPICAL		RLD, RS	2016-02-05

Orange Book patents#

Current patent rows page 1 of 1 · 7 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N208079-001	10179137	2030-08-31	U-1858	Drug product	2019-02-08
N208079-001	9364485	2030-08-31	U-1858	Drug product	2016-06-29
N208079-001	9433630	2030-08-31	U-1858	Drug product	2016-09-14
N208079-001	9439911	2030-08-31	U-1858	Drug product	2016-09-21
N208079-001	9655907	2030-08-31	U-1858	Drug product	2017-06-02
N208079-001	9775851	2030-08-31	U-1858	Drug product	2017-10-17
N208079-001	9877974	2030-08-31	U-1858	Drug product	2018-02-15

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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N208079-001	SERNIVO	EQ 0.05% BASE/SPRAY	SPRAY / TOPICAL	RLD, RS	2016-02-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208079-001	SERNIVO	EQ 0.05% BASE/SPRAY	SPRAY / TOPICAL	RLD, RS	2016-02-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N208079-001	SERNIVO	EQ 0.05% BASE/SPRAY	SPRAY / TOPICAL	RLD, RS	2016-02-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208079-001	SERNIVO	EQ 0.05% BASE/SPRAY	SPRAY / TOPICAL	RLD, RS	2016-02-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208079-001	SERNIVO	EQ 0.05% BASE/SPRAY	SPRAY / TOPICAL	RLD, RS	2016-02-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208079-001	SERNIVO	EQ 0.05% BASE/SPRAY	SPRAY / TOPICAL	RLD, RS	2016-02-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208079-001	SERNIVO	EQ 0.05% BASE/SPRAY	SPRAY / TOPICAL	RLD, RS	2016-02-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208079-001	SERNIVO	EQ 0.05% BASE/SPRAY	SPRAY / TOPICAL	RLD, RS	2016-02-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208079-001	SERNIVO	EQ 0.05% BASE/SPRAY	SPRAY / TOPICAL	RLD, RS	2016-02-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N208079-001	SERNIVO	EQ 0.05% BASE/SPRAY	SPRAY / TOPICAL	RLD, RS	2016-02-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208079-001	SERNIVO	EQ 0.05% BASE/SPRAY	SPRAY / TOPICAL	RLD, RS	2016-02-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208079-001	SERNIVO	EQ 0.05% BASE/SPRAY	SPRAY / TOPICAL	RLD, RS	2016-02-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N208079-001	SERNIVO	EQ 0.05% BASE/SPRAY	SPRAY / TOPICAL	RLD, RS	2016-02-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N208079-001	SERNIVO	EQ 0.05% BASE/SPRAY	SPRAY / TOPICAL	RLD, RS	2016-02-05	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208079-001	SERNIVO	EQ 0.05% BASE/SPRAY	SPRAY / TOPICAL	RLD, RS	2016-02-05	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N208079-001	SERNIVO	EQ 0.05% BASE/SPRAY	SPRAY / TOPICAL	RLD, RS	2016-02-05	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N208079-001	SERNIVO	EQ 0.05% BASE/SPRAY	SPRAY / TOPICAL	RLD, RS	2016-02-05	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N208079-001	SERNIVO	EQ 0.05% BASE/SPRAY	SPRAY / TOPICAL	RLD, RS	2016-02-05	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N208079-001	SERNIVO	EQ 0.05% BASE/SPRAY	SPRAY / TOPICAL	RLD, RS	2016-02-05	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N208079-001	SERNIVO	EQ 0.05% BASE/SPRAY	SPRAY / TOPICAL	RLD, RS	2016-02-05	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N208079-001	SERNIVO	EQ 0.05% BASE/SPRAY	SPRAY / TOPICAL	RLD, RS	2016-02-05	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N208079-001	SERNIVO	EQ 0.05% BASE/SPRAY	SPRAY / TOPICAL	RLD, RS	2016-02-05	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N208079-001	SERNIVO	EQ 0.05% BASE/SPRAY	SPRAY / TOPICAL	RLD, RS	2016-02-05	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N208079-001	SERNIVO	EQ 0.05% BASE/SPRAY	SPRAY / TOPICAL	RLD, RS	2016-02-05	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N208079-001	SERNIVO	EQ 0.05% BASE/SPRAY	SPRAY / TOPICAL	RLD, RS	2016-02-05	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N208079-001	SERNIVO	EQ 0.05% BASE/SPRAY	SPRAY / TOPICAL	RLD, RS	2016-02-05	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N208079-001	SERNIVO	EQ 0.05% BASE/SPRAY	SPRAY / TOPICAL	RLD, RS	2016-02-05	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N208079-001	SERNIVO	EQ 0.05% BASE/SPRAY	SPRAY / TOPICAL	RLD, RS	2016-02-05	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N208079-001	SERNIVO	EQ 0.05% BASE/SPRAY	SPRAY / TOPICAL	RLD, RS	2016-02-05	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N208079-001	SERNIVO	EQ 0.05% BASE/SPRAY	SPRAY / TOPICAL	RLD, RS	2016-02-05	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N208079-001	SERNIVO	EQ 0.05% BASE/SPRAY	SPRAY / TOPICAL	RLD, RS	2016-02-05	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N208079-001	SERNIVO	EQ 0.05% BASE/SPRAY	SPRAY / TOPICAL	RLD, RS	2016-02-05	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N208079-001	SERNIVO	EQ 0.05% BASE/SPRAY	SPRAY / TOPICAL	RLD, RS	2016-02-05	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N208079-001	SERNIVO	EQ 0.05% BASE/SPRAY	SPRAY / TOPICAL	RLD, RS	2016-02-05	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N208079-001	SERNIVO	EQ 0.05% BASE/SPRAY	SPRAY / TOPICAL	RLD, RS	2016-02-05	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N208079-001	SERNIVO	EQ 0.05% BASE/SPRAY	SPRAY / TOPICAL	RLD, RS	2016-02-05	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N208079-001	SERNIVO	EQ 0.05% BASE/SPRAY	SPRAY / TOPICAL	RLD, RS	2016-02-05	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N208079-001	SERNIVO	EQ 0.05% BASE/SPRAY	SPRAY / TOPICAL	RLD, RS	2016-02-05	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N208079-001	SERNIVO	EQ 0.05% BASE/SPRAY	SPRAY / TOPICAL	RLD, RS	2016-02-05	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N208079-001	SERNIVO	EQ 0.05% BASE/SPRAY	SPRAY / TOPICAL	RLD, RS	2016-02-05	`cb3db0bc1861…`

Observed Orange Book patent history#

Patent history page 1 of 8 · 287 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N208079-001	10179137	2030-08-31	U-1858	Drug product	2019-02-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208079-001	9364485	2030-08-31	U-1858	Drug product	2016-06-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208079-001	9433630	2030-08-31	U-1858	Drug product	2016-09-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208079-001	9439911	2030-08-31	U-1858	Drug product	2016-09-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208079-001	9655907	2030-08-31	U-1858	Drug product	2017-06-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208079-001	9775851	2030-08-31	U-1858	Drug product	2017-10-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208079-001	9877974	2030-08-31	U-1858	Drug product	2018-02-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208079-001	10179137	2030-08-31	U-1858	Drug product	2019-02-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208079-001	9364485	2030-08-31	U-1858	Drug product	2016-06-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208079-001	9433630	2030-08-31	U-1858	Drug product	2016-09-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208079-001	9439911	2030-08-31	U-1858	Drug product	2016-09-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208079-001	9655907	2030-08-31	U-1858	Drug product	2017-06-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208079-001	9775851	2030-08-31	U-1858	Drug product	2017-10-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208079-001	9877974	2030-08-31	U-1858	Drug product	2018-02-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N208079-001	10179137	2030-08-31	U-1858	Drug product	2019-02-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208079-001	9364485	2030-08-31	U-1858	Drug product	2016-06-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208079-001	9433630	2030-08-31	U-1858	Drug product	2016-09-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208079-001	9439911	2030-08-31	U-1858	Drug product	2016-09-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208079-001	9655907	2030-08-31	U-1858	Drug product	2017-06-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208079-001	9775851	2030-08-31	U-1858	Drug product	2017-10-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208079-001	9877974	2030-08-31	U-1858	Drug product	2018-02-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208079-001	10179137	2030-08-31	U-1858	Drug product	2019-02-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208079-001	9364485	2030-08-31	U-1858	Drug product	2016-06-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208079-001	9433630	2030-08-31	U-1858	Drug product	2016-09-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208079-001	9439911	2030-08-31	U-1858	Drug product	2016-09-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208079-001	9655907	2030-08-31	U-1858	Drug product	2017-06-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208079-001	9775851	2030-08-31	U-1858	Drug product	2017-10-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208079-001	9877974	2030-08-31	U-1858	Drug product	2018-02-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208079-001	10179137	2030-08-31	U-1858	Drug product	2019-02-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208079-001	9364485	2030-08-31	U-1858	Drug product	2016-06-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208079-001	9433630	2030-08-31	U-1858	Drug product	2016-09-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208079-001	9439911	2030-08-31	U-1858	Drug product	2016-09-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208079-001	9655907	2030-08-31	U-1858	Drug product	2017-06-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208079-001	9775851	2030-08-31	U-1858	Drug product	2017-10-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208079-001	9877974	2030-08-31	U-1858	Drug product	2018-02-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208079-001	10179137	2030-08-31	U-1858	Drug product	2019-02-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208079-001	9364485	2030-08-31	U-1858	Drug product	2016-06-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208079-001	9433630	2030-08-31	U-1858	Drug product	2016-09-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208079-001	9439911	2030-08-31	U-1858	Drug product	2016-09-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208079-001	9655907	2030-08-31	U-1858	Drug product	2017-06-02	`03ed91905a0d…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N208079-001	NDF	2019-02-05	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	N208079-001	NDF	2019-02-05	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N208079-001	NDF	2019-02-05	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N208079-001	NDF	2019-02-05	`ea99ee380514…`

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
Sernivo	BETAMETHASONE DIPROPIONATE	Primus Pharmaceuticals, Inc.	b1b3d1b0-da9b-11eb-ad76-0800200c9a66	2026-04-22	Warnings, Adverse reactions	Exact identifier application applno (NDA): 208079 application number: NDA208079 ndc (product): 68040-714

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
67857-808	Sernivo	betamethasone dipropionate	Promius Pharma, LLC	NDA	Current
68040-714	Sernivo	betamethasone dipropionate	Primus Pharmaceuticals, Inc.	NDA	Current
68040-714	Sernivo	betamethasone dipropionate	Primus Pharmaceuticals, Inc.	NDA	Current
68040-714	Sernivo	betamethasone dipropionate	Primus Pharmaceuticals, Inc.	NDA	Current
69482-800	Sernivo	betamethasone dipropionate	Encore Dermatology Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
62349	SUPPL	2020-03-26
62311	SUPPL	2020-03-25
56666	SUPPL	2018-12-07
56617	SUPPL	2018-12-03
49518	ORIG	2017-08-23
32887	ORIG	2016-02-09
19983	ORIG	2016-02-09