Miconazole 7 Combination Pack

   
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Miconazole 7 Combination Pack


Drug - Miconazole 7 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%,100MG
The potency of the active ingredient(s), Miconazole Nitrate. May repeat for multiple part products.

Applicant - G AND W LABS
The firm name holding legal responsibility for Miconazole 7 Combination Pack. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 076585
The FDA assigned number to Miconazole 7 Combination Pack. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Miconazole 7 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 - Mar 26, 2004
The date Miconazole 7 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 7 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 7 Combination Pack is in. Format is RX, OTC, DISCN.

Applicant Full Name - G And W Laboratories Inc
The full name of the firm holding legal responsibility for the new application of Miconazole 7 Combination Pack.

Miconazole 7 Combination Pack