Hylorel

   
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Hylorel


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

Dosage - TABLET; ORAL
The product dosage form and route separated by a semi-colon.

Active Ingredient(s) - Guanadrel Sulfate
Multiple ingredients are in alphabetical order.

Strength - 25MG
The potency of the active ingredient(s), Guanadrel Sulfate. May repeat for multiple part products.

Applicant - PHARMACIA AND UPJOHN
The firm name holding legal responsibility for Hylorel. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 018104
The FDA assigned number to Hylorel. Format is nnnnnn.

Product Number - 002
The FDA assigned number to identify Hylorel. 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 29, 1982
The date Hylorel 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 Hylorel. 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 Hylorel is in. Format is RX, OTC, DISCN.

Applicant Full Name - Pharmacia And Upjohn Co
The full name of the firm holding legal responsibility for the new application of Hylorel.

Hylorel