Leuprolide Acetate

   
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Leuprolide Acetate


Drug - Leuprolide Acetate
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 - BEDFORD LABS
The firm name holding legal responsibility for Leuprolide Acetate. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 074728
The FDA assigned number to Leuprolide Acetate. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Leuprolide Acetate. 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 - Aug 4, 1998
The date Leuprolide Acetate 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 Leuprolide Acetate. 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 Leuprolide Acetate is in. Format is RX, OTC, DISCN.

Applicant Full Name - Bedford Laboratories Inc
The full name of the firm holding legal responsibility for the new application of Leuprolide Acetate.

Leuprolide Acetate