Benzaclin

   
Google
 
Web NewDrugInformation.com

Benzaclin


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

Dosage - GEL; TOPICAL
The product dosage form and route separated by a semi-colon.

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

Strength - 5%;EQ 1% BASE
The potency of the active ingredient(s), Benzoyl Peroxide; Clindamycin Phosphate. May repeat for multiple part products.

Applicant - DERMIK LABS
The firm name holding legal responsibility for Benzaclin. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 050756
The FDA assigned number to Benzaclin. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Benzaclin. Each strength is a separate product. May repeat for multiple part products. Format is nnn.

Therapeutic Equivalence (TE) Code - BT
The TE Code indicates the therapeutic equivalence rating of generic to innovator Rx products.

Approval Date - Dec 21, 2000
The date Benzaclin 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 Benzaclin. 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 Benzaclin is in. Format is RX, OTC, DISCN.

Applicant Full Name - Dermik Laboratories Div Aventis Pharmaceuticals Inc
The full name of the firm holding legal responsibility for the new application of Benzaclin.

Benzaclin