Clindesse

   
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Clindesse


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

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

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

Strength - EQ 2% BASE
The potency of the active ingredient(s), Clindamycin Phosphate. May repeat for multiple part products.

Applicant - KV PHARM
The firm name holding legal responsibility for Clindesse. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 050793
The FDA assigned number to Clindesse. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Clindesse. 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 - Nov 30, 2004
The date Clindesse 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 Clindesse. 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 Clindesse is in. Format is RX, OTC, DISCN.

Applicant Full Name - Kv Pharmaceutical Co
The full name of the firm holding legal responsibility for the new application of Clindesse.

Clindesse