Cytovene Iv

   
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Cytovene Iv


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

Dosage - INJECTABLE; INJECTION
The product dosage form and route separated by a semi-colon.

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

Strength - EQ 500MG BASE/VIAL
The potency of the active ingredient(s), Ganciclovir Sodium. May repeat for multiple part products.

Applicant - ROCHE PALO
The firm name holding legal responsibility for Cytovene Iv. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 019661
The FDA assigned number to Cytovene Iv. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Cytovene Iv. Each strength is a separate product. May repeat for multiple part products. Format is nnn.

Therapeutic Equivalence (TE) Code - AP
The TE Code indicates the therapeutic equivalence rating of generic to innovator Rx products.

Approval Date - Jun 23, 1989
The date Cytovene Iv 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 Cytovene Iv. 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 Cytovene Iv is in. Format is RX, OTC, DISCN.

Applicant Full Name - Roche Palo Alto Llc
The full name of the firm holding legal responsibility for the new application of Cytovene Iv.

Cytovene Iv