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FDA Product

Phentermine Hydrochloride

Product approved by U.S. Food and Drug Administration (US)

Basic Information

Phentermine Hydrochloride

63629-1106

Regulatory Information

63629-1106

ANDA040526

C73584

July 5, 2020

USA

These highlights do not include all the information needed to use PHENTERMINE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for PHENTERMINE HYDROCHLORIDE TABLETS. PHENTERMINE HYDROCHLORIDE tablets, for oral use, CIV Initial U.S. Approval: 1959

HUMAN PRESCRIPTION DRUG LABEL

4

Company Information

171714327

Active Ingredients

Phentermine Hydrochloride

Quantity: 30 mg in 1 1

Code: 0K2I505OTV

Class Code: ACTIM

CROSPOVIDONE (15 MPA.S AT 5%)

Code: 68401960MK

Class Code: IACT

DIBASIC CALCIUM PHOSPHATE DIHYDRATE

Code: O7TSZ97GEP

Class Code: IACT

FD&C Blue No. 1

Code: H3R47K3TBD

Class Code: IACT

POVIDONE, UNSPECIFIED

Code: FZ989GH94E

Class Code: IACT

magnesium stearate

Code: 70097M6I30

Class Code: IACT

Active Moieties

Phentermine

Code: C045TQL4WP

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