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Phentermine Hydrochloride

PHENTERMINE HYDROCHLORIDE TABLETS USP, 37.5 mg CIV

Approved
Approval ID

a894c87a-f04d-4080-a52b-b3fd8b8b6e01

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Dec 29, 2011

Manufacturers
FDA

H.J. Harkins Company, Inc.

DUNS: 147681894

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 Code52959-812
Application NumberANDA040527
Product Classification
M
Marketing Category
C73584
G
Generic Name
Phentermine Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateDecember 29, 2011
FDA Product Classification

INGREDIENTS (2)

Phentermine HydrochlorideActive
Quantity: 37.5 mg in 1 1
Code: 0K2I505OTV
Classification: ACTIB
povidoneInactive
Code: FZ989GH94E
Classification: IACT

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Phentermine Hydrochloride - FDA Drug Approval Details