Follistim Aq

   
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Follistim Aq


Drug - Follistim Aq
The trade name of the product as shown on the labeling.

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

Active Ingredient(s) - Follitropin Alfa/beta
Multiple ingredients are in alphabetical order.

Strength - 150 IU/0.5ML
The potency of the active ingredient(s), Follitropin Alfa/beta. May repeat for multiple part products.

Applicant - ORGANON USA INC
The firm name holding legal responsibility for Follistim Aq. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 021273
The FDA assigned number to Follistim Aq. Format is nnnnnn.

Product Number - 002
The FDA assigned number to identify Follistim Aq. 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 - Aug 26, 2005
The date Follistim Aq 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 Follistim Aq. 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 Follistim Aq is in. Format is RX, OTC, DISCN.

Applicant Full Name - Organon Usa Inc
The full name of the firm holding legal responsibility for the new application of Follistim Aq.

Follistim Aq