Doryx

   
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Doryx


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

Dosage - TABLET, DELAYED RELEASE; 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 100MG BASE
The potency of the active ingredient(s), Doxycycline Hyclate. May repeat for multiple part products.

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

New Drug Application (NDA) Number - 050795
The FDA assigned number to Doryx. Format is nnnnnn.

Product Number - 002
The FDA assigned number to identify Doryx. 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 - May 6, 2005
The date Doryx 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 Doryx. 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 Doryx is in. Format is RX, OTC, DISCN.

Applicant Full Name - Faulding Pharmaceuticals Sub Fh Faulding And Co Ltd
The full name of the firm holding legal responsibility for the new application of Doryx.

Doryx