Mycelex-7 Combination Pack

   
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Mycelex-7 Combination Pack


Drug - Mycelex-7 Combination Pack
The trade name of the product as shown on the labeling.

Dosage - CREAM, TABLET; TOPICAL, VAGINAL
The product dosage form and route separated by a semi-colon.

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

Strength - 1%,100MG
The potency of the active ingredient(s), Clotrimazole. May repeat for multiple part products.

Applicant - BAYER PHARMS
The firm name holding legal responsibility for Mycelex-7 Combination Pack. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 020389
The FDA assigned number to Mycelex-7 Combination Pack. Format is nnnnnn.

Product Number - 002
The FDA assigned number to identify Mycelex-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 - Jun 23, 1994
The date Mycelex-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 Mycelex-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 Mycelex-7 Combination Pack is in. Format is RX, OTC, DISCN.

Applicant Full Name - Bayer Pharmaceuticals Corp
The full name of the firm holding legal responsibility for the new application of Mycelex-7 Combination Pack.

Mycelex-7 Combination Pack