Gyne-lotrimin Combination Pack

   
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Gyne-lotrimin Combination Pack


Drug - Gyne-lotrimin 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 - SCHERING PLOUGH
The firm name holding legal responsibility for Gyne-lotrimin Combination Pack. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 020289
The FDA assigned number to Gyne-lotrimin Combination Pack. Format is nnnnnn.

Product Number - 002
The FDA assigned number to identify Gyne-lotrimin 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 26, 1993
The date Gyne-lotrimin 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) - Yes
The pioneer or innovator of Gyne-lotrimin 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 Gyne-lotrimin Combination Pack is in. Format is RX, OTC, DISCN.

Applicant Full Name - Schering Plough Healthcare Products Inc
The full name of the firm holding legal responsibility for the new application of Gyne-lotrimin Combination Pack.

Gyne-lotrimin Combination Pack