Megace

   
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Megace


Drug - Megace
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) - Megestrol Acetate
Multiple ingredients are in alphabetical order.

Strength - 20MG
The potency of the active ingredient(s), Megestrol Acetate. May repeat for multiple part products.

Applicant - BRISTOL MYERS SQUIBB
The firm name holding legal responsibility for Megace. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 016979
The FDA assigned number to Megace. Format is nnnnnn.

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

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

Approval Date - Approved Prior to Jan 1, 1982
The date Megace 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 Megace. 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 Megace is in. Format is RX, OTC, DISCN.

Applicant Full Name - Bristol Myers Squibb
The full name of the firm holding legal responsibility for the new application of Megace.

Megace