Periostat

   
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Periostat


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

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

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

Strength - EQ 20MG BASE
The potency of the active ingredient(s), Doxycycline Hyclate. May repeat for multiple part products.

Applicant - COLLAGENEX PHARMS
The firm name holding legal responsibility for Periostat. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 050783
The FDA assigned number to Periostat. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Periostat. 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 - Feb 2, 2001
The date Periostat 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 Periostat. 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 Periostat is in. Format is RX, OTC, DISCN.

Applicant Full Name - Collagenex Pharmaceuticals Inc
The full name of the firm holding legal responsibility for the new application of Periostat.

Periostat