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AZITHROMYCIN

Approved
Approval ID

6fadde9e-dab3-4d01-b3fb-795eef7eff2f

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Feb 1, 2010

Manufacturers
FDA

Rebel Distributors Corp.

DUNS: 118802834

Products 2

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

AZITHROMYCIN

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code21695-013
Application NumberANDA065405
Product Classification
M
Marketing Category
C73584
G
Generic Name
AZITHROMYCIN
Product Specifications
Route of AdministrationORAL
Effective DateDecember 16, 2009
FDA Product Classification

INGREDIENTS (1)

AZITHROMYCIN ANHYDROUSActive
Quantity: 500 mg in 1 1
Code: J2KLZ20U1M
Classification: ACTIM

AZITHROMYCIN

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code21695-012
Application NumberANDA065404
Product Classification
M
Marketing Category
C73584
G
Generic Name
AZITHROMYCIN
Product Specifications
Route of AdministrationORAL
Effective DateDecember 16, 2009
FDA Product Classification

INGREDIENTS (1)

AZITHROMYCIN ANHYDROUSActive
Quantity: 250 mg in 1 1
Code: J2KLZ20U1M
Classification: ACTIM

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AZITHROMYCIN - FDA Drug Approval Details