FDA Product

Amoxapine

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

Basic Information

Product Name

Amoxapine

FDA Product Code

0591-5714

Regulatory Information

NDC Product Code

0591-5714

Application Number

ANDA072691

Marketing Category

C73584

Effective Date

February 28, 2015

Territorial Authority

USA

FDA Title

Revised: February 2015

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

18

Company Information

ManufacturerActavis Pharma, Inc.

DUNS Number

119723554

Active Ingredients

FD&C YELLOW NO. 6

Code: H77VEI93A8

Class Code: IACT

ANHYDROUS DIBASIC CALCIUM PHOSPHATE

Code: L11K75P92J

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

Quantity: 50 mg in 1 1

Code: R63VQ857OT

Class Code: ACTIB

STARCH, CORN

Code: O8232NY3SJ

Class Code: IACT

STEARIC ACID

Code: 4ELV7Z65AP

Class Code: IACT

Active Moieties

AMOXAPINE

Code: R63VQ857OT

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