Orvaten
Drug - Orvaten
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) -
Midodrine Hydrochloride
Multiple ingredients are in alphabetical order.
Strength -
5MG
The potency of the active ingredient(s), Midodrine Hydrochloride. May repeat for multiple part products.
Applicant -
UPSHER SMITH
The firm name holding legal responsibility for Orvaten. The firm name is condensed to a maximum twenty character unique string.
New Drug Application (NDA) Number -
076725
The FDA assigned number to Orvaten. Format is nnnnnn.
Product Number -
002
The FDA assigned number to identify Orvaten. 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 -
Nov 3, 2004
The date Orvaten 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 Orvaten. 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 Orvaten is in. Format is RX, OTC, DISCN.
Applicant Full Name -
Upsher Smith Laboratories Inc
The full name of the firm holding legal responsibility for the new application of Orvaten.
Orvaten
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