Miconazole 7
Drug - Miconazole 7
The trade name of the product as shown on the labeling.
Dosage -
CREAM; VAGINAL
The product dosage form and route separated by a semi-colon.
Active Ingredient(s) -
Miconazole Nitrate
Multiple ingredients are in alphabetical order.
Strength -
2%
The potency of the active ingredient(s), Miconazole Nitrate. May repeat for multiple part products.
Applicant -
ALPHARMA US PHARMS
The firm name holding legal responsibility for Miconazole 7. The firm name is condensed to a maximum twenty character unique string.
New Drug Application (NDA) Number -
074164
The FDA assigned number to Miconazole 7. Format is nnnnnn.
Product Number -
001
The FDA assigned number to identify Miconazole 7. Each strength is a separate product. May repeat for multiple part products. Format is nnn.
Therapeutic Equivalence (TE) Code -
The TE Code indicates the therapeutic equivalence rating of generic to innovator Rx products.
Approval Date -
Mar 29, 1996
The date Miconazole 7 was approved as stated in the FDA approval letter to the applicant. The format is Mmm dd, yyyy. Products approved prior to the January 1, 1982 contain the phrase: "Approved prior to Jan 1, 1982".
Reference Listed Drug (RLD) -
No
The pioneer or innovator of Miconazole 7. The RLD identifies the product Abbreviated New Drug Applications (ANDA) use as a reference. Format is Yes or No.
Type -
OTC
The group or category of approved drugs Miconazole 7 is in. Format is RX, OTC, DISCN.
Applicant Full Name -
Alpharma Us Pharmaceuticals Division
The full name of the firm holding legal responsibility for the new application of Miconazole 7.
Miconazole 7
M-zole 3 Combination Pack 2%,200mg Cream, Suppository; Topical, Vaginal M-zole 7 Dual Pack 2%,100mg Cream, Suppository; Topical, Vaginal Monistat-derm 2% Cream; Topical Miconazole 3 Combination Pack 2%,4% Cream; Topical, Vaginal Monistat 3 Combination Pack 2%,4% Cream; Topical, Vaginal Monistat 3 Combination Pack (prefilled) 2%,4% Cream; Topical, Vaginal Miconazole 3 4% Cream; Vaginal Miconazole 7 2% Cream; Vaginal Monistat 7 Combination Pack 2%,100mg Cream, Suppository; Topical, Vaginal Monistat-3 Combination Pack 2%,200mg Cream, Suppository; Topical, Vaginal
NewDrugInformation
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