Claravis

   
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Claravis


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

Dosage - CAPSULE; ORAL
The product dosage form and route separated by a semi-colon.

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

Strength - 10MG
The potency of the active ingredient(s), Isotretinoin. May repeat for multiple part products.

Applicant - BARR
The firm name holding legal responsibility for Claravis. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 076356
The FDA assigned number to Claravis. Format is nnnnnn.

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

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

Approval Date - Apr 11, 2003
The date Claravis 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 Claravis. 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 Claravis is in. Format is RX, OTC, DISCN.

Applicant Full Name - Barr Laboratories Inc
The full name of the firm holding legal responsibility for the new application of Claravis.

Claravis