M-zole 3 Combination Pack
Drug - M-zole 3 Combination Pack
The trade name of the product as shown on the labeling.
Dosage -
CREAM, SUPPOSITORY; TOPICAL, 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%,200MG
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 M-zole 3 Combination Pack. The firm name is condensed to a maximum twenty character unique string.
New Drug Application (NDA) Number -
074926
The FDA assigned number to M-zole 3 Combination Pack. Format is nnnnnn.
Product Number -
001
The FDA assigned number to identify M-zole 3 Combination Pack. 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 -
Apr 16, 1999
The date M-zole 3 Combination Pack 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 M-zole 3 Combination Pack. 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 M-zole 3 Combination Pack 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 M-zole 3 Combination Pack.
M-zole 3 Combination Pack
M-zole 3 Combination Pack 2%,200mg Cream, Suppository; Topical, Vaginal Mezlin Eq 4gm Base/vial Injectable; Injection Mezlin Eq 4gm Base/vial Injectable; Injection Mycamine 50mg/vial Injectable; Iv (infusion) Monistat 10mg/ml Injectable; Injection Miconazole 7 Combination Pack 2%,100mg Cream, Suppository; Topical, Vaginal Miconazole Nitrate Combination Pack 2%,200mg Cream, Suppository; Topical, 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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