Application 016322

Type: NDA
Sponsor: SCHERING

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	VALISONE	BETAMETHASONE VALERATE	CREAM;TOPICAL	EQ 0.1% BASE	No	No
002	VALISONE	BETAMETHASONE VALERATE	CREAM;TOPICAL	EQ 0.01% BASE	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N016322-001	VALISONE	BETAMETHASONE VALERATE	EQ 0.1% BASE	CREAM / TOPICAL		Approved before 1982
N016322-002	VALISONE	BETAMETHASONE VALERATE	EQ 0.01% BASE	CREAM / TOPICAL		Approved before 1982

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 2 of 3 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N016322-001	VALISONE	EQ 0.1% BASE	CREAM / TOPICAL	Approved before 1982	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N016322-002	VALISONE	EQ 0.01% BASE	CREAM / TOPICAL	Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N016322-001	VALISONE	EQ 0.1% BASE	CREAM / TOPICAL	Approved before 1982	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N016322-002	VALISONE	EQ 0.01% BASE	CREAM / TOPICAL	Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N016322-001	VALISONE	EQ 0.1% BASE	CREAM / TOPICAL	Approved before 1982	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N016322-002	VALISONE	EQ 0.01% BASE	CREAM / TOPICAL	Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N016322-001	VALISONE	EQ 0.1% BASE	CREAM / TOPICAL	Approved before 1982	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N016322-002	VALISONE	EQ 0.01% BASE	CREAM / TOPICAL	Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N016322-001	VALISONE	EQ 0.1% BASE	CREAM / TOPICAL	Approved before 1982	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N016322-002	VALISONE	EQ 0.01% BASE	CREAM / TOPICAL	Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N016322-001	VALISONE	EQ 0.1% BASE	CREAM / TOPICAL	Approved before 1982	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N016322-002	VALISONE	EQ 0.01% BASE	CREAM / TOPICAL	Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N016322-001	VALISONE	EQ 0.1% BASE	CREAM / TOPICAL	Approved before 1982	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N016322-002	VALISONE	EQ 0.01% BASE	CREAM / TOPICAL	Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N016322-001	VALISONE	EQ 0.1% BASE	CREAM / TOPICAL	Approved before 1982	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N016322-002	VALISONE	EQ 0.01% BASE	CREAM / TOPICAL	Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N016322-001	VALISONE	EQ 0.1% BASE	CREAM / TOPICAL	Approved before 1982	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N016322-002	VALISONE	EQ 0.01% BASE	CREAM / TOPICAL	Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N016322-001	VALISONE	EQ 0.1% BASE	CREAM / TOPICAL	Approved before 1982	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N016322-002	VALISONE	EQ 0.01% BASE	CREAM / TOPICAL	Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N016322-001	VALISONE	EQ 0.1% BASE	CREAM / TOPICAL	Approved before 1982	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N016322-002	VALISONE	EQ 0.01% BASE	CREAM / TOPICAL	Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N016322-001	VALISONE	EQ 0.1% BASE	CREAM / TOPICAL	Approved before 1982	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N016322-002	VALISONE	EQ 0.01% BASE	CREAM / TOPICAL	Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N016322-001	VALISONE	EQ 0.1% BASE	CREAM / TOPICAL	Approved before 1982	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N016322-002	VALISONE	EQ 0.01% BASE	CREAM / TOPICAL	Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N016322-001	VALISONE	EQ 0.1% BASE	CREAM / TOPICAL	Approved before 1982	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N016322-002	VALISONE	EQ 0.01% BASE	CREAM / TOPICAL	Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N016322-001	VALISONE	EQ 0.1% BASE	CREAM / TOPICAL	Approved before 1982	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N016322-002	VALISONE	EQ 0.01% BASE	CREAM / TOPICAL	Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N016322-001	VALISONE	EQ 0.1% BASE	CREAM / TOPICAL	Approved before 1982	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N016322-002	VALISONE	EQ 0.01% BASE	CREAM / TOPICAL	Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N016322-001	VALISONE	EQ 0.1% BASE	CREAM / TOPICAL	Approved before 1982	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N016322-002	VALISONE	EQ 0.01% BASE	CREAM / TOPICAL	Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N016322-001	VALISONE	EQ 0.1% BASE	CREAM / TOPICAL	Approved before 1982	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N016322-002	VALISONE	EQ 0.01% BASE	CREAM / TOPICAL	Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N016322-001	VALISONE	EQ 0.1% BASE	CREAM / TOPICAL	Approved before 1982	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N016322-002	VALISONE	EQ 0.01% BASE	CREAM / TOPICAL	Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N016322-001	VALISONE	EQ 0.1% BASE	CREAM / TOPICAL	Approved before 1982	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N016322-002	VALISONE	EQ 0.01% BASE	CREAM / TOPICAL	Approved before 1982	`3a93d1ddd44b…`

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 · 18 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Betamethasone Valerate	BETAMETHASONE VALERATE	Sun Pharmaceutical Industries, Inc.	7c96b978-25ff-44c2-bc9c-30ff5e34cffb	2026-03-23	Warnings, Adverse reactions	Name fallback generic name: BETAMETHASONE VALERATE
Betamethasone Valerate	BETAMETHASONE VALERATE	Preferred Pharmaceuticals Inc.	50d4763d-5a84-4c45-be06-040c4a527470	2026-03-19	Adverse reactions	Name fallback generic name: BETAMETHASONE VALERATE
BETAMETHASONE VALERATE	BETAMETHASONE VALERATE	Preferred Pharmaceuticals, Inc.	bfa4b6f5-3b66-430a-af41-60e3f12982bc	2026-03-19	Adverse reactions	Name fallback generic name: BETAMETHASONE VALERATE
BETAMETHASONE VALERATE	BETAMETHASONE VALERATE	A-S Medication Solutions	7281d272-5342-4738-b35c-42570459e9d4	2026-02-04	Adverse reactions	Name fallback generic name: BETAMETHASONE VALERATE
Betamethasone Valerate	BETAMETHASONE VALERATE	E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC	0b386ccc-a2d4-4d18-a2d7-e46ff894c674	2026-01-28	Adverse reactions	Name fallback generic name: BETAMETHASONE VALERATE
BETAMETHASONE VALERATE	BETAMETHASONE VALERATE	Sun Pharmaceutical Industries, Inc.	3c85be0f-2731-44f1-a18e-d3852d54846f	2025-10-02	Adverse reactions	Name fallback generic name: BETAMETHASONE VALERATE
Betamethasone valerate	BETAMETHASONE VALERATE	Alembic Pharmaceuticals Limited	75d70e76-023c-4a00-954d-79a697bed80f	2025-09-25	Adverse reactions	Name fallback generic name: BETAMETHASONE VALERATE
Betamethasone Valerate	BETAMETHASONE VALERATE	Preferred Pharmaceuticals Inc.	985d1f62-4bff-4bf1-b7c7-96cb456ef83d	2025-02-07	Adverse reactions	Name fallback generic name: BETAMETHASONE VALERATE
BETAMETHASONE VALERATE	BETAMETHASONE VALERATE	A-S Medication Solutions	02db1402-701c-483c-bfd6-8b7a543ae8ef	2024-11-11	Adverse reactions	Name fallback generic name: BETAMETHASONE VALERATE
Betamethasone valerate	BETAMETHASONE VALERATE	Alembic Pharmaceuticals Inc.	3b6fa573-de04-4626-a39a-dca39def6df2	2024-08-23	Adverse reactions	Name fallback generic name: BETAMETHASONE VALERATE
Betamethasone Valerate	BETAMETHASONE VALERATE	NuCare Pharmaceuticals,Inc.	a2154b33-0f61-49af-e053-2995a90a1810	2024-06-20	Adverse reactions	Name fallback generic name: BETAMETHASONE VALERATE
BETAMETHASONE VALERATE	BETAMETHASONE VALERATE	NuCare Pharmaceuticals,Inc.	64badc1a-8922-c6e3-e053-2991aa0a8b1c	2024-06-06	Adverse reactions	Name fallback generic name: BETAMETHASONE VALERATE
Betamethasone Valerate	BETAMETHASONE VALERATE	Padagis Israel Pharmaceuticals Ltd	dc5dfd3e-7762-40c8-880e-c7db80d87749	2024-03-31	Warnings, Adverse reactions	Name fallback generic name: BETAMETHASONE VALERATE
Betamethasone Valerate	BETAMETHASONE VALERATE	A-S Medication Solutions	f8711d17-de6a-45e3-8027-b650308207ed	2023-12-15	Adverse reactions	Name fallback generic name: BETAMETHASONE VALERATE
Betamethasone Valerate	BETAMETHASONE VALERATE	A-S Medication Solutions	d265d143-343f-41ec-9cb4-18d83edb772b	2023-12-12	Adverse reactions	Name fallback generic name: BETAMETHASONE VALERATE
Betamethasone Valerate	BETAMETHASONE VALERATE	Proficient Rx LP	036706f1-0a24-4765-9a62-820ad64934be	2022-06-01	Adverse reactions	Name fallback generic name: BETAMETHASONE VALERATE
Betamethasone Valerate	BETAMETHASONE VALERATE	Cosette Pharmaceuticals, Inc.	784476d2-5e5c-fdba-a677-8973a777b5ef	2022-05-05	Adverse reactions	Name fallback generic name: BETAMETHASONE VALERATE
Betamethasone Valerate	BETAMETHASONE VALERATE	Proficient Rx LP	2a64b65b-8a49-45ea-9464-2269751c075c	2021-04-01	Adverse reactions	Name fallback generic name: BETAMETHASONE VALERATE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.