TEMOVATE E

Product NDC
10337-301
11-digit product format
103370301
Labeler code
10337
Product ID
10337-301_ee16de89-1d93-43cb-9c93-2eab26bf180e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
clobetasol propionate
Dosage form
CREAM
Route
TOPICAL
Labeler
PharmaDerm a division of Fougera Pharmaceuticals Inc.
Application
ANDA075430
Marketing category
ANDA
Marketing start
1999-05-26
Marketing end
0000-00-00
Substance
CLOBETASOL PROPIONATE
Active strength
1 mg/g
Pharmacologic classes
Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct10337-301DDiscontinued by firm2026-08-03
excluded packagepackage10337-30110337-301-60DDiscontinued by firm2026-08-03

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A075430-001CLOBETASOL PROPIONATE (EMOLLIENT)CLOBETASOL PROPIONATE0.05%CREAM / TOPICALAB2RS1999-05-26

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A075430-001AB2

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A075430-001CLOBETASOL PROPIONATE (EMOLLIENT)0.05%CREAM / TOPICALAB2RS1999-05-26a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A075430-001AB21a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Clobetasol Propionate (emollient)CLOBETASOL PROPIONATEE. Fougera & Co. a division of Fougera Pharmaceuticals Inc.fdfd83ee-dfb4-4c12-a74e-a0053e34e08c2021-07-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075430
application number: ANDA075430

FDA-Initiated Inactive NDC Indexing#

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
clobetasol propionateACTIVE INGREDIENT779619577MTEMOVATE E (CLOBETASOL PROPIONATE) CREAM [PHARMADERM A DIVISION OF FOUGERA PHARMACEUTICALS INC.]4
clobetasolACTIVE MOIETYADN79D536HTEMOVATE E (CLOBETASOL PROPIONATE) CREAM [PHARMADERM A DIVISION OF FOUGERA PHARMACEUTICALS INC.]4
ceteth-20INACTIVE INGREDIENTI835H2IHHXTEMOVATE E (CLOBETASOL PROPIONATE) CREAM [PHARMADERM A DIVISION OF FOUGERA PHARMACEUTICALS INC.]4
cetostearyl alcoholINACTIVE INGREDIENT2DMT128M1STEMOVATE E (CLOBETASOL PROPIONATE) CREAM [PHARMADERM A DIVISION OF FOUGERA PHARMACEUTICALS INC.]4
citric acid monohydrateINACTIVE INGREDIENT2968PHW8QPTEMOVATE E (CLOBETASOL PROPIONATE) CREAM [PHARMADERM A DIVISION OF FOUGERA PHARMACEUTICALS INC.]4
dimethicone 350INACTIVE INGREDIENT2Y53S6ATLUTEMOVATE E (CLOBETASOL PROPIONATE) CREAM [PHARMADERM A DIVISION OF FOUGERA PHARMACEUTICALS INC.]4
imidureaINACTIVE INGREDIENTM629807ATLTEMOVATE E (CLOBETASOL PROPIONATE) CREAM [PHARMADERM A DIVISION OF FOUGERA PHARMACEUTICALS INC.]4
isopropyl myristateINACTIVE INGREDIENT0RE8K4LNJSTEMOVATE E (CLOBETASOL PROPIONATE) CREAM [PHARMADERM A DIVISION OF FOUGERA PHARMACEUTICALS INC.]4
propylene glycolINACTIVE INGREDIENT6DC9Q167V3TEMOVATE E (CLOBETASOL PROPIONATE) CREAM [PHARMADERM A DIVISION OF FOUGERA PHARMACEUTICALS INC.]4
sodium citrateINACTIVE INGREDIENT1Q73Q2JULRTEMOVATE E (CLOBETASOL PROPIONATE) CREAM [PHARMADERM A DIVISION OF FOUGERA PHARMACEUTICALS INC.]4
waterINACTIVE INGREDIENT059QF0KO0RTEMOVATE E (CLOBETASOL PROPIONATE) CREAM [PHARMADERM A DIVISION OF FOUGERA PHARMACEUTICALS INC.]4