Hepsera

   
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Hepsera


Drug - Hepsera
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) - Adefovir Dipivoxil
Multiple ingredients are in alphabetical order.

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

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

New Drug Application (NDA) Number - 021449
The FDA assigned number to Hepsera. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Hepsera. 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 - Sep 20, 2002
The date Hepsera 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 Hepsera. 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 Hepsera is in. Format is RX, OTC, DISCN.

Applicant Full Name - Gilead Sciences Inc
The full name of the firm holding legal responsibility for the new application of Hepsera.

Hepsera