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RELEGARD

RELEGARD THERAPEUTIC VAGINAL GEL WITH APPLICATOR

Approved
Approval ID

dd1b4ad8-08f2-4412-8a98-2d82ef35f053

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Mar 20, 2017

Manufacturers
FDA

BLANSETT PHARMACAL CO

DUNS: 037477378

Products 1

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

GLACIAL ACETIC ACID, OXYQUINOLINE

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code51674-0130
Product Classification
G
Generic Name
GLACIAL ACETIC ACID, OXYQUINOLINE
Product Specifications
Route of AdministrationTOPICAL
Effective DateMarch 20, 2017
FDA Product Classification

INGREDIENTS (7)

GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
LACTIC ACIDInactive
Code: 33X04XA5AT
Classification: IACT
POLYETHYLENE GLYCOL 4500Inactive
Code: TVH7653921
Classification: IACT
ACETIC ACIDActive
Quantity: 0.9 mg in 1 mL
Code: Q40Q9N063P
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
OXYQUINOLINEActive
Quantity: 0.025 mg in 1 mL
Code: 5UTX5635HP
Classification: ACTIB

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RELEGARD - FDA Drug Approval Details