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Phentermine HCL C-IV

Phentermine HCL C-IV

Approved
Approval ID

e4a2996e-2bfa-376f-e053-2995a90a0ed1

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jul 25, 2022

Manufacturers
FDA

Direct_Rx

DUNS: 079254320

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Phentermine HCL C-IV

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code72189-365
Application NumberANDA205019
Product Classification
M
Marketing Category
C73584
G
Generic Name
Phentermine HCL C-IV
Product Specifications
Route of AdministrationORAL
Effective DateJuly 25, 2022
FDA Product Classification

INGREDIENTS (18)

BUTYL ALCOHOLInactive
Code: 8PJ61P6TS3
Classification: IACT
PHENTERMINE HYDROCHLORIDEActive
Quantity: 15 mg in 1 1
Code: 0K2I505OTV
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
FD&C RED NO. 3Inactive
Code: PN2ZH5LOQY
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
FD&C YELLOW NO. 5Inactive
Code: I753WB2F1M
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT

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Phentermine HCL C-IV - FDA Drug Approval Details