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Terconazole

Terconazole Vaginal Suppositories 80 mg

Approved
Approval ID

38cd1718-6b3c-415d-a17f-7b399adb0ba2

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Nov 23, 2022

Manufacturers
FDA

Cosette Pharmaceuticals, Inc.

DUNS: 116918230

Products 1

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

Terconazole

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code0713-0552
Application NumberANDA077553
Product Classification
M
Marketing Category
C73584
G
Generic Name
Terconazole
Product Specifications
Route of AdministrationVAGINAL
Effective DateNovember 23, 2022
FDA Product Classification

INGREDIENTS (4)

BUTYLATED HYDROXYANISOLEInactive
Code: REK4960K2U
Classification: IACT
COCONUT OILInactive
Code: Q9L0O73W7L
Classification: IACT
PALM KERNEL OILInactive
Code: B0S90M0233
Classification: IACT
TERCONAZOLEActive
Quantity: 80 mg in 1 1
Code: 0KJ2VE664U
Classification: ACTIB

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Terconazole - FDA Drug Approval Details