Zerit Xr

   
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Zerit Xr


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

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

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

Strength - 75MG
The potency of the active ingredient(s), Stavudine. May repeat for multiple part products.

Applicant - BRISTOL MYERS SQUIBB
The firm name holding legal responsibility for Zerit Xr. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 021453
The FDA assigned number to Zerit Xr. Format is nnnnnn.

Product Number - 003
The FDA assigned number to identify Zerit Xr. 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 - Dec 31, 2002
The date Zerit Xr 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 Zerit Xr. The RLD identifies the product Abbreviated New Drug Applications (ANDA) use as a reference. Format is Yes or No.

Type - DISCN
The group or category of approved drugs Zerit Xr is in. Format is RX, OTC, DISCN.

Applicant Full Name - Bristol Myers Squibb Co
The full name of the firm holding legal responsibility for the new application of Zerit Xr.

Zerit Xr