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Details for New Drug Application (NDA): 020670

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NDA 020670 describes MONISTAT 3 COMBINATION PACK, which is a drug marketed by Medtech Products and is included in two NDAs. It is available from three suppliers. Additional details are available on the MONISTAT 3 COMBINATION PACK profile page.

The generic ingredient in MONISTAT 3 COMBINATION PACK is miconazole nitrate. There are twenty-eight drug master file entries for this compound. Fifty-four suppliers are listed for this compound. Additional details are available on the miconazole nitrate profile page.

Summary for NDA: 020670

Therapeutic Class:Antifungals
Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 020670

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
miconazole nitrate
CREAM, SUPPOSITORY;TOPICAL, VAGINAL 020670 NDA Physicians Total Care, Inc. 54868-4238 54868-4238-0 1 KIT in 1 PACKAGE, COMBINATION * 3 SUPPOSITORY in 1 BLISTER PACK * 9 g in 1 TUBE
miconazole nitrate
CREAM, SUPPOSITORY;TOPICAL, VAGINAL 020670 NDA Insight Pharmaceuticals 63736-002 63736-002-03 1 KIT in 1 PACKAGE, COMBINATION (63736-002-03) * 3 POUCH in 1 KIT > 1 SUPPOSITORY in 1 POUCH * 9 g in 1 TUBE

Summary for product number 002

Active Rx/OTC/Discontinued:OTCDosage:CREAM, SUPPOSITORY;TOPICAL, VAGINALStrength2%,200MG
Approval Date:Apr 16, 1996TE:RLD:Yes

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.