Lupron

   
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Lupron


Drug - Lupron
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) - Leuprolide Acetate
Multiple ingredients are in alphabetical order.

Strength - 1MG/0.2ML
The potency of the active ingredient(s), Leuprolide Acetate. May repeat for multiple part products.

Applicant - TAP PHARM
The firm name holding legal responsibility for Lupron. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 019010
The FDA assigned number to Lupron. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Lupron. Each strength is a separate product. May repeat for multiple part products. Format is nnn.

Therapeutic Equivalence (TE) Code - AP
The TE Code indicates the therapeutic equivalence rating of generic to innovator Rx products.

Approval Date - Apr 9, 1985
The date Lupron 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 Lupron. 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 Lupron is in. Format is RX, OTC, DISCN.

Applicant Full Name - Tap Pharmaceutical Products Inc
The full name of the firm holding legal responsibility for the new application of Lupron.

Lupron