Optipranolol
Drug - Optipranolol
The trade name of the product as shown on the labeling.
Dosage -
SOLUTION/DROPS; OPHTHALMIC
The product dosage form and route separated by a semi-colon.
Active Ingredient(s) -
Metipranolol Hydrochloride
Multiple ingredients are in alphabetical order.
Strength -
0.3%
The potency of the active ingredient(s), Metipranolol Hydrochloride. May repeat for multiple part products.
Applicant -
BAUSCH AND LOMB
The firm name holding legal responsibility for Optipranolol. The firm name is condensed to a maximum twenty character unique string.
New Drug Application (NDA) Number -
019907
The FDA assigned number to Optipranolol. Format is nnnnnn.
Product Number -
001
The FDA assigned number to identify Optipranolol. Each strength is a separate product. May repeat for multiple part products. Format is nnn.
Therapeutic Equivalence (TE) Code -
AT
The TE Code indicates the therapeutic equivalence rating of generic to innovator Rx products.
Approval Date -
Dec 29, 1989
The date Optipranolol 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 Optipranolol. 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 Optipranolol is in. Format is RX, OTC, DISCN.
Applicant Full Name -
Bausch And Lomb Pharmaceuticals Inc
The full name of the firm holding legal responsibility for the new application of Optipranolol.
Optipranolol
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