Betamethasone Dipropionate
These highlights do not include all the information needed to use BETAMETHASONE DIPROPIONATE Lotion (Augmented), 0.05% safely and effectively. See full prescribing information for BETAMETHASONE DIPROPIONATE Lotion (Augmented), 0.05%. BETAMETHASONE DIPROPIONATE lotion (Augmented), 0.05% for topical useInitial U.S. Approval: 1983
Approved
Approval ID
4f411e41-00dc-47cf-8517-3ff5876e1bf5
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 30, 2022
Manufacturers
FDA
E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.
DUNS: 043838424
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Betamethasone Dipropionate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0168-0267
Application NumberANDA077111
Product Classification
M
Marketing Category
C73584
G
Generic Name
Betamethasone Dipropionate
Product Specifications
Route of AdministrationTOPICAL
Effective DateJune 4, 2019
FDA Product Classification
INGREDIENTS (7)
propylene glycolInactive
Code: 6DC9Q167V3
Classification: IACT
isopropyl alcoholInactive
Code: ND2M416302
Classification: IACT
BETAMETHASONE DIPROPIONATEActive
Quantity: 0.5 mg in 1 mL
Code: 826Y60901U
Classification: ACTIM
waterInactive
Code: 059QF0KO0R
Classification: IACT
phosphoric acidInactive
Code: E4GA8884NN
Classification: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671P
Classification: IACT
SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORMInactive
Code: 3980JIH2SW
Classification: IACT