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Amoxicillin

Amoxicillin Tablets

Approved
Approval ID

6dcd320a-2ba4-4dad-8173-1cef72b4c816

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jul 8, 2011

Manufacturers
FDA

RedPharm Drug Inc.

DUNS: 008039641

Products 1

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

Amoxicillin

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code67296-0220
Application NumberANDA065291
Product Classification
M
Marketing Category
C73584
G
Generic Name
Amoxicillin
Product Specifications
Route of AdministrationORAL
Effective DateJuly 8, 2011
FDA Product Classification

INGREDIENTS (7)

AmoxicillinActive
Quantity: 500 mg in 1 1
Code: 804826J2HU
Classification: ACTIB
gelatinInactive
Code: 2G86QN327L
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT

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Amoxicillin - FDA Drug Approval Details