M-zole 7 Dual Pack

   
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M-zole 7 Dual Pack


Drug - M-zole 7 Dual 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%,100MG
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 7 Dual Pack. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 074586
The FDA assigned number to M-zole 7 Dual Pack. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify M-zole 7 Dual 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 - Jul 17, 1997
The date M-zole 7 Dual 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 7 Dual 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 7 Dual 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 7 Dual Pack.

M-zole 7 Dual Pack