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Phentermine Hydrochloride

PHENTERMINE HYDROCHLORIDE TABLETS USP, 37.5 mg CIV

Approved
Approval ID

462eefa0-6224-42c2-af3f-c598de0d8010

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Mar 8, 2012

Manufacturers
FDA

Life Line Home Care Services, Inc.

DUNS: 844985374

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 Code75921-025
Application NumberANDA040876
Product Classification
M
Marketing Category
C73584
G
Generic Name
Phentermine Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateMarch 8, 2012
FDA Product Classification

INGREDIENTS (9)

FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
Phentermine HydrochlorideActive
Quantity: 37.5 mg in 1 1
Code: 0K2I505OTV
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT

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Phentermine Hydrochloride - FDA Drug Approval Details