Miconazole Nitrate Combination Pack

   
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Miconazole Nitrate Combination Pack


Drug - Miconazole Nitrate 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 - PERRIGO
The firm name holding legal responsibility for Miconazole Nitrate Combination Pack. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 075329
The FDA assigned number to Miconazole Nitrate Combination Pack. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Miconazole Nitrate 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 20, 1999
The date Miconazole Nitrate 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 Miconazole Nitrate 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 Miconazole Nitrate Combination Pack is in. Format is RX, OTC, DISCN.

Applicant Full Name - Perrigo Co
The full name of the firm holding legal responsibility for the new application of Miconazole Nitrate Combination Pack.

Miconazole Nitrate Combination Pack