Miconazole 3
Drug - Miconazole 3
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 -
4%
The potency of the active ingredient(s), Miconazole Nitrate. May repeat for multiple part products.
Applicant -
TARO
The firm name holding legal responsibility for Miconazole 3. The firm name is condensed to a maximum twenty character unique string.
New Drug Application (NDA) Number -
076773
The FDA assigned number to Miconazole 3. Format is nnnnnn.
Product Number -
001
The FDA assigned number to identify Miconazole 3. 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 2, 2005
The date Miconazole 3 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 3. 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 3 is in. Format is RX, OTC, DISCN.
Applicant Full Name -
Taro Pharmaceuticals Usa Inc
The full name of the firm holding legal responsibility for the new application of Miconazole 3.
Miconazole 3
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 Monistat 1 Combination Pack 1.2gm,2% Cream, Suppository; Topical, 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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