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FDA Approval

ciprofloxacin

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

FDA Approval Summary

Company
RedPharm Drug, Inc.
DUNS: 828374897
Effective Date
January 20, 2022
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Ciprofloxacin(750 mg in 1 1)

Manufacturing Establishments1

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

RedPharm Drug, Inc.

RedPharm Drug, Inc.

828374897

Products1

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

ciprofloxacin

Product Details

NDC Product Code
67296-1269
Application Number
ANDA076639
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
January 20, 2022
HYPROMELLOSESInactive
Code: 3NXW29V3WOClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
CROSPOVIDONE (15 MPA.S AT 5%)Inactive
Code: 68401960MKClass: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1AClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
Code: 4BA73M5E37Class: ACTIMQuantity: 750 mg in 1 1
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
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