Repronex

   
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Repronex


Drug - Repronex
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) - Menotropins (fsh;lh)
Multiple ingredients are in alphabetical order.

Strength - 150 IU/VIAL;150 IU/VIAL
The potency of the active ingredient(s), Menotropins (fsh;lh). May repeat for multiple part products.

Applicant - FERRING
The firm name holding legal responsibility for Repronex. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 021047
The FDA assigned number to Repronex. Format is nnnnnn.

Product Number - 002
The FDA assigned number to identify Repronex. 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 27, 1999
The date Repronex 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 Repronex. 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 Repronex is in. Format is RX, OTC, DISCN.

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

Repronex