Combivir

   
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Combivir


Drug - Combivir
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) - Lamivudine; Zidovudine
Multiple ingredients are in alphabetical order.

Strength - 150MG;300MG
The potency of the active ingredient(s), Lamivudine; Zidovudine. May repeat for multiple part products.

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

New Drug Application (NDA) Number - 020857
The FDA assigned number to Combivir. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Combivir. 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 26, 1997
The date Combivir 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 Combivir. 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 Combivir is in. Format is RX, OTC, DISCN.

Applicant Full Name - Glaxosmithkline
The full name of the firm holding legal responsibility for the new application of Combivir.

Combivir