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AMOXAPINE

Amoxapine Tablets USPRevised: June 2009Rx only        190829

Approved
Approval ID

261006c8-3fd0-491b-b322-42beff6f9880

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jul 9, 2010

Manufacturers
FDA

Physicians Total Care, Inc.

DUNS: 194123980

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

amoxapine

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code54868-2438
Application NumberANDA072689
Product Classification
M
Marketing Category
C73584
G
Generic Name
amoxapine
Product Specifications
Route of AdministrationORAL
Effective DateMay 16, 2011
FDA Product Classification

INGREDIENTS (6)

AMOXAPINEActive
Quantity: 50 mg in 1 1
Code: R63VQ857OT
Classification: ACTIB
DIBASIC CALCIUM PHOSPHATE DIHYDRATEInactive
Code: O7TSZ97GEP
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT

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AMOXAPINE - FDA Drug Approval Details