FDA.report

Application 020670

Type
NDA
Sponsor
MEDTECH PRODUCTS

Related Records

Application Products

ProductDrugIngredientFormStrengthReference drugReference standard
002MONISTAT 3 COMBINATION PACKMICONAZOLE NITRATECREAM, SUPPOSITORY;TOPICAL, VAGINAL2%,200MGYesYes

NDC Listings For This Application

NDCNameNonproprietary nameLabelerMarketing categoryStatus
0363-5203Miconazole 3Miconazole nitrateWALGREEN COMPANYNDACurrent
51316-005Miconazole 1 Combination PackMiconazole NitrateCVS PHARMACY, INCNDACurrent
57501-006Monistat 3 Combination PackMiconazole NitrateApex International Mfg., Inc.NDACurrent
63736-002Monistat 3 Combination PackMiconazole NitrateInsight PharmaceuticalsNDACurrent
63736-010Monistat 3 Combination PackMiconazole NitrateInsight Pharmaceuticals LLCNDACurrent
63736-010Monistat 3 Combination PackMiconazole NitrateInsight Pharmaceuticals LLCNDACurrent
63736-016Monistat 3 Combination PackMiconazole NitrateInsight PharmaceuticalsNDACurrent
63736-017MONISTAT 3Miconazole NitrateInsight Pharmaceuticals LLCNDACurrent
63736-018Monistat 3 Combination PackMiconazole NitrateInsight PharmaceuticalsNDACurrent
63736-019Monistat 3 Combination PackMiconazole NitrateInsight Pharmaceuticals LLCNDACurrent
69842-950Miconazole 3Miconazole nitrateCVS PharmacyNDACurrent

Documents

DocumentSubmission typeDate
76665SUPPL 2023-11-24
76632SUPPL 2023-11-20
70540SUPPL2022-03-17
70398SUPPL2022-03-04
61721SUPPL2020-01-29
61720SUPPL2020-01-29
41536SUPPL2014-07-02
41537SUPPL2012-11-09
13179SUPPL2007-03-23
3052SUPPL2007-03-23
25484SUPPL2003-01-09