Melfiat
Drug - Melfiat
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) -
Phendimetrazine Tartrate
Multiple ingredients are in alphabetical order.
Strength -
35MG
The potency of the active ingredient(s), Phendimetrazine Tartrate. May repeat for multiple part products.
Applicant -
NUMARK
The firm name holding legal responsibility for Melfiat. The firm name is condensed to a maximum twenty character unique string.
New Drug Application (NDA) Number -
083790
The FDA assigned number to Melfiat. Format is nnnnnn.
Product Number -
002
The FDA assigned number to identify Melfiat. 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 -
Approved Prior to Jan 1, 1982
The date Melfiat 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 Melfiat. 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 Melfiat is in. Format is RX, OTC, DISCN.
Applicant Full Name -
Numark Laboratories Inc
The full name of the firm holding legal responsibility for the new application of Melfiat.
Melfiat
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