Tiopronin
Drug - Tiopronin
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) -
Tiopronin
Multiple ingredients are in alphabetical order.
Strength -
100MG
The potency of the active ingredient(s), Tiopronin. May repeat for multiple part products.
Applicant -
MISSION PHARMA
The firm name holding legal responsibility for Tiopronin. The firm name is condensed to a maximum twenty character unique string.
New Drug Application (NDA) Number -
019569
The FDA assigned number to Tiopronin. Format is nnnnnn.
Product Number -
001
The FDA assigned number to identify Tiopronin. 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 -
Aug 11, 1988
The date Tiopronin 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 Tiopronin. 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 Tiopronin 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 Tiopronin.
Tiopronin
|
