Application 021261

Type
NDA
Sponsor
MEDTECH PRODUCTS

Related Records

Application Products

ProductDrugIngredientFormStrengthReference drugReference standard
001MONISTAT 3 COMBINATION PACK (PREFILLED)MICONAZOLE NITRATECREAM;TOPICAL, VAGINAL2%,4%YesYes
003MONISTAT 3 COMBINATION PACKMICONAZOLE NITRATECREAM;TOPICAL, VAGINAL2%,4%YesNo

Documents

DocumentSubmission typeDate
70548SUPPL2022-03-17
70400SUPPL2022-03-04
61729SUPPL2020-01-29
61728SUPPL2020-01-29
49513SUPPL2017-08-22
27254SUPPL2008-10-30
4822SUPPL2003-06-22
42060ORIG2001-08-21
36500ORIG2001-02-02
27253ORIG2001-02-02