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CIPROFLOXACIN

Ciprofloxacin Tablets 250 mg, 500 mg and 750 mg

Approved
Approval ID

1e815845-5336-4b5f-975a-39d79b30cd10

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Oct 19, 2009

Manufacturers
FDA

STAT RX USA LLC

DUNS: 786036330

Products 1

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

CIPROFLOXACIN

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code16590-054
Application NumberANDA076639
Product Classification
M
Marketing Category
C73584
G
Generic Name
CIPROFLOXACIN
Product Specifications
Route of AdministrationORAL
Effective DateOctober 19, 2009
FDA Product Classification

INGREDIENTS (10)

CIPROFLOXACIN HYDROCHLORIDEActive
Quantity: 500 mg in 1 1
Code: 4BA73M5E37
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSEInactive
Code: 3NXW29V3WO
Classification: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT

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CIPROFLOXACIN - FDA Drug Approval Details