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PHENTERMINE HYDROCHLORIDE

PHENTERMINE HCI 15MG USP CAPSULES PHENTERMINE HCI 30MG USP CAPSULES Rx Only

Approved
Approval ID

139b0347-9954-4913-b1c1-d9506fc91393

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Feb 16, 2012

Manufacturers
FDA

Dispensing Solutions, Inc.

DUNS: 066070785

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 Code66336-185
Application NumberANDA040875
Product Classification
M
Marketing Category
C73584
G
Generic Name
PHENTERMINE HYDROCHLORIDE
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 16, 2012
FDA Product Classification

INGREDIENTS (8)

PHENTERMINE HYDROCHLORIDEActive
Quantity: 30 mg in 1 1
Code: 0K2I505OTV
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FD&C RED NO. 3Inactive
Code: PN2ZH5LOQY
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT

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PHENTERMINE HYDROCHLORIDE - FDA Drug Approval Details