Lithostat
Drug - Lithostat
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) -
Acetohydroxamic Acid
Multiple ingredients are in alphabetical order.
Strength -
250MG
The potency of the active ingredient(s), Acetohydroxamic Acid. May repeat for multiple part products.
Applicant -
MISSION PHARMA
The firm name holding legal responsibility for Lithostat. The firm name is condensed to a maximum twenty character unique string.
New Drug Application (NDA) Number -
018749
The FDA assigned number to Lithostat. Format is nnnnnn.
Product Number -
001
The FDA assigned number to identify Lithostat. 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 -
May 31, 1983
The date Lithostat 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) -
Yes
The pioneer or innovator of Lithostat. 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 Lithostat is in. Format is RX, OTC, DISCN.
Applicant Full Name -
Mission Pharmacal Co
The full name of the firm holding legal responsibility for the new application of Lithostat.
Lithostat
|
