Levatol
Drug - Levatol
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) -
Penbutolol Sulfate
Multiple ingredients are in alphabetical order.
Strength -
10MG
The potency of the active ingredient(s), Penbutolol Sulfate. May repeat for multiple part products.
Applicant -
SCHWARZ PHARMA
The firm name holding legal responsibility for Levatol. The firm name is condensed to a maximum twenty character unique string.
New Drug Application (NDA) Number -
018976
The FDA assigned number to Levatol. Format is nnnnnn.
Product Number -
001
The FDA assigned number to identify Levatol. 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 -
Dec 30, 1987
The date Levatol 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 Levatol. 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 Levatol is in. Format is RX, OTC, DISCN.
Applicant Full Name -
Schwarz Pharma Inc
The full name of the firm holding legal responsibility for the new application of Levatol.
Levatol
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