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Last Updated: November 4, 2024

Details for New Drug Application (NDA): 021308


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NDA 021308 describes MONISTAT 1 COMBINATION PACK, which is a drug marketed by Medtech Products and is included in one NDA. It is available from one supplier. Additional details are available on the MONISTAT 1 COMBINATION PACK profile page.

The generic ingredient in MONISTAT 1 COMBINATION PACK is miconazole nitrate. There are twenty-eight drug master file entries for this compound. Fifty-one suppliers are listed for this compound. Additional details are available on the miconazole nitrate profile page.
Summary for 021308
Tradename:MONISTAT 1 COMBINATION PACK
Applicant:Medtech Products
Ingredient:miconazole nitrate
Patents:0
Suppliers and Packaging for NDA: 021308
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MONISTAT 1 COMBINATION PACK miconazole nitrate CREAM, INSERT;TOPICAL, VAGINAL 021308 NDA Insight Pharmaceuticals LLC 63736-013 63736-013-30 1 KIT in 1 PACKAGE, COMBINATION (63736-013-30) * 1 SUPPOSITORY in 1 POUCH * 9 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:OTCDosage:CREAM, INSERT;TOPICAL, VAGINALStrength2%,1.2GM
Approval Date:Jun 29, 2001TE:RLD:Yes

Expired US Patents for NDA 021308

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Medtech Products MONISTAT 1 COMBINATION PACK miconazole nitrate CREAM, INSERT;TOPICAL, VAGINAL 021308-001 Jun 29, 2001 ⤷  Sign Up ⤷  Sign Up
Medtech Products MONISTAT 1 COMBINATION PACK miconazole nitrate CREAM, INSERT;TOPICAL, VAGINAL 021308-001 Jun 29, 2001 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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