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Ciprofloxacin

CIPROFLOXACIN TABLETS, USP

Approved
Approval ID

0a9891a2-fd39-47b0-adb2-2ed8392b6aff

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jun 27, 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.

ciprofloxacin hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code67296-0608
Application NumberANDA076794
Product Classification
M
Marketing Category
C73584
G
Generic Name
ciprofloxacin hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJune 24, 2009
FDA Product Classification

INGREDIENTS (10)

STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
crospovidoneInactive
Code: 68401960MK
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
polyvinyl alcoholInactive
Code: 532B59J990
Classification: IACT
silicon dioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
talcInactive
Code: 7SEV7J4R1U
Classification: IACT
polyethylene glycolInactive
Code: 3WJQ0SDW1A
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
ciprofloxacin hydrochlorideActive
Quantity: 250 mg in 1 1
Code: 4BA73M5E37
Classification: ACTIM

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Ciprofloxacin - FDA Drug Approval Details