Miconazole Nitrate

   
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Miconazole Nitrate


Drug - Miconazole Nitrate
The trade name of the product as shown on the labeling.

Dosage - SUPPOSITORY; VAGINAL
The product dosage form and route separated by a semi-colon.

Active Ingredient(s) - Miconazole Nitrate
Multiple ingredients are in alphabetical order.

Strength - 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 Miconazole Nitrate. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 073508
The FDA assigned number to Miconazole Nitrate. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Miconazole Nitrate. Each strength is a separate product. May repeat for multiple part products. Format is nnn.

Therapeutic Equivalence (TE) Code - AB
The TE Code indicates the therapeutic equivalence rating of generic to innovator Rx products.

Approval Date - Nov 19, 1993
The date Miconazole Nitrate 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. The RLD identifies the product Abbreviated New Drug Applications (ANDA) use as a reference. Format is Yes or No.

Type - RX
The group or category of approved drugs Miconazole Nitrate 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 Nitrate.

Miconazole Nitrate