LOMAIRA
LOMAIRA™ (phentermine hydrochloride USP) tablets, CIV
Approved
Approval ID
0718f0f3-77f2-45d7-be12-1ed718c8b806
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 7, 2023
Manufacturers
FDA
Calvin Scott & Co., Inc.
DUNS: 073404626
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
PHENTERMINE HYDROCHLORIDE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code17224-840
Application NumberANDA203495
Product Classification
M
Marketing Category
C73584
G
Generic Name
PHENTERMINE HYDROCHLORIDE
Product Specifications
Route of AdministrationORAL
Effective DateApril 7, 2023
FDA Product Classification
INGREDIENTS (7)
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
PHENTERMINE HYDROCHLORIDEActive
Quantity: 8 mg in 1 1
Code: 0K2I505OTV
Classification: ACTIB