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FDA Approval

CEFPROZIL

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
RedPharm Drug Inc.
DUNS: 008039641
Effective Date
July 7, 2011
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Cefprozil(500 mg in 1 1)

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

LUPIN LIMITED

RedPharm Drug Inc.

725504448

Products1

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

CEFPROZIL

Product Details

NDC Product Code
67296-0590
Application Number
ANDA065276
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
July 7, 2011
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
CefprozilActive
Code: 4W0459ZA4VClass: ACTIMQuantity: 500 mg in 1 1
METHYLCELLULOSE (15 CPS)Inactive
Code: NPU9M2E6L8Class: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
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