Supprelin

   
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Supprelin


Drug - Supprelin
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) - Histrelin Acetate
Multiple ingredients are in alphabetical order.

Strength - EQ 0.2MG BASE/ML
The potency of the active ingredient(s), Histrelin Acetate. May repeat for multiple part products.

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

New Drug Application (NDA) Number - 019836
The FDA assigned number to Supprelin. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Supprelin. 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 - Dec 24, 1991
The date Supprelin 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 Supprelin. 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 Supprelin is in. Format is RX, OTC, DISCN.

Applicant Full Name - Shire Development Inc
The full name of the firm holding legal responsibility for the new application of Supprelin.

Supprelin