Gyne-lotrimin 3
Drug - Gyne-lotrimin 3
The trade name of the product as shown on the labeling.
Dosage -
TABLET; VAGINAL
The product dosage form and route separated by a semi-colon.
Active Ingredient(s) -
Clotrimazole
Multiple ingredients are in alphabetical order.
Strength -
200MG
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 3. The firm name is condensed to a maximum twenty character unique string.
New Drug Application (NDA) Number -
020525
The FDA assigned number to Gyne-lotrimin 3. Format is nnnnnn.
Product Number -
001
The FDA assigned number to identify Gyne-lotrimin 3. 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 -
Jul 29, 1996
The date Gyne-lotrimin 3 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 3. 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 3 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 3.
Gyne-lotrimin 3
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