Ovidrel

   
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Ovidrel


Drug - Ovidrel
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) - Choriogonadotropin Alfa
Multiple ingredients are in alphabetical order.

Strength - 0.25MG/VIAL
The potency of the active ingredient(s), Choriogonadotropin Alfa. May repeat for multiple part products.

Applicant - SERONO INC
The firm name holding legal responsibility for Ovidrel. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 021149
The FDA assigned number to Ovidrel. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Ovidrel. 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, 2000
The date Ovidrel 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 Ovidrel. 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 Ovidrel is in. Format is RX, OTC, DISCN.

Applicant Full Name - Serono Inc
The full name of the firm holding legal responsibility for the new application of Ovidrel.

Ovidrel