Metronidazole
METRONIDAZOLE TOPICAL LOTION, 0.75%
Approved
Approval ID
5368755a-dd37-4e34-843f-ece6bac8ef6a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 6, 2022
Manufacturers
FDA
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.
Metronidazole
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0168-0383
Application NumberANDA077197
Product Classification
M
Marketing Category
C73584
G
Generic Name
Metronidazole
Product Specifications
Route of AdministrationTOPICAL
Effective DateJuly 6, 2022
FDA Product Classification
INGREDIENTS (15)
METRONIDAZOLEActive
Quantity: 7.5 mg in 1 mL
Code: 140QMO216E
Classification: ACTIB
BENZYL ALCOHOLInactive
Code: LKG8494WBH
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
CARBOMER HOMOPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)Inactive
Code: F68VH75CJC
Classification: IACT
GLYCERYL MONOSTEARATEInactive
Code: 230OU9XXE4
Classification: IACT
LIGHT MINERAL OILInactive
Code: N6K5787QVP
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
PEG-100 STEARATEInactive
Code: YD01N1999R
Classification: IACT
POTASSIUM SORBATEInactive
Code: 1VPU26JZZ4
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
STEARETH-21Inactive
Code: 53J3F32P58
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
STEARYL ALCOHOLInactive
Code: 2KR89I4H1Y
Classification: IACT
CYCLOMETHICONEInactive
Code: NMQ347994Z
Classification: IACT
LACTIC ACID, UNSPECIFIED FORMInactive
Code: 33X04XA5AT
Classification: IACT