Acyclovir

   
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Acyclovir


Drug - Acyclovir
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) - Acyclovir Sodium
Multiple ingredients are in alphabetical order.

Strength - EQ 50MG BASE/ML
The potency of the active ingredient(s), Acyclovir Sodium. May repeat for multiple part products.

Applicant - SICOR PHARMS
The firm name holding legal responsibility for Acyclovir. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 075627
The FDA assigned number to Acyclovir. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Acyclovir. 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 - Mar 28, 2001
The date Acyclovir 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 Acyclovir. 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 Acyclovir is in. Format is RX, OTC, DISCN.

Applicant Full Name - Sicor Pharmaceuticals Inc
The full name of the firm holding legal responsibility for the new application of Acyclovir.

Acyclovir