Bicillin L-a
Drug - Bicillin L-a
The trade name of the product as shown on the labeling.
Dosage -
INJECTABLE; INJECTION
The product dosage form and route separated by a semi-colon.
Active Ingredient(s) -
Penicillin G Benzathine
Multiple ingredients are in alphabetical order.
Strength -
300,000 UNITS/ML
The potency of the active ingredient(s), Penicillin G Benzathine. May repeat for multiple part products.
Applicant -
KING PHARMS
The firm name holding legal responsibility for Bicillin L-a. The firm name is condensed to a maximum twenty character unique string.
New Drug Application (NDA) Number -
050141
The FDA assigned number to Bicillin L-a. Format is nnnnnn.
Product Number -
003
The FDA assigned number to identify Bicillin L-a. 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 -
Approved Prior to Jan 1, 1982
The date Bicillin L-a 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 Bicillin L-a. 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 Bicillin L-a is in. Format is RX, OTC, DISCN.
Applicant Full Name -
King Pharmaceuticals Inc
The full name of the firm holding legal responsibility for the new application of Bicillin L-a.
Bicillin L-a
|