Lunelle

   
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Lunelle


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

Dosage - INJECTABLE; INTRAMUSCULAR
The product dosage form and route separated by a semi-colon.

Active Ingredient(s) - Estradiol Cypionate; Medroxyprogesterone Acetate
Multiple ingredients are in alphabetical order.

Strength - 5MG/0.5ML;25MG/0.5ML
The potency of the active ingredient(s), Estradiol Cypionate; Medroxyprogesterone Acetate. May repeat for multiple part products.

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

New Drug Application (NDA) Number - 020874
The FDA assigned number to Lunelle. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Lunelle. 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 - Oct 5, 2000
The date Lunelle 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 Lunelle. 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 Lunelle 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 Lunelle.

Lunelle