Isoptin
Drug - Isoptin
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) -
Verapamil Hydrochloride
Multiple ingredients are in alphabetical order.
Strength -
80MG
The potency of the active ingredient(s), Verapamil Hydrochloride. May repeat for multiple part products.
Applicant -
FSC
The firm name holding legal responsibility for Isoptin. The firm name is condensed to a maximum twenty character unique string.
New Drug Application (NDA) Number -
018593
The FDA assigned number to Isoptin. Format is nnnnnn.
Product Number -
001
The FDA assigned number to identify Isoptin. 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 -
Mar 8, 1982
The date Isoptin 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 Isoptin. 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 Isoptin is in. Format is RX, OTC, DISCN.
Applicant Full Name -
Fsc Laboratories Inc
The full name of the firm holding legal responsibility for the new application of Isoptin.
Isoptin
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