Penicillin G Procaine
Drug - Penicillin G Procaine
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 Procaine
Multiple ingredients are in alphabetical order.
Strength -
300,000 UNITS/ML
The potency of the active ingredient(s), Penicillin G Procaine. May repeat for multiple part products.
Applicant -
KING PHARMS
The firm name holding legal responsibility for Penicillin G Procaine. The firm name is condensed to a maximum twenty character unique string.
New Drug Application (NDA) Number -
060101
The FDA assigned number to Penicillin G Procaine. Format is nnnnnn.
Product Number -
002
The FDA assigned number to identify Penicillin G Procaine. 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 Penicillin G Procaine 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 Penicillin G Procaine. 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 Penicillin G Procaine 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 Penicillin G Procaine.
Penicillin G Procaine
Pfizerpen G 200,000 Units Tablet; Oral Pfizerpen G 250,000 Units Tablet; Oral Pfizerpen G 400,000 Units Tablet; Oral Pfizerpen G 50,000 Units Tablet; Oral Pfizerpen G 800,000 Units Tablet; Oral Duracillin A.S. 300,000 Units/ml Injectable; Injection Penicillin G Procaine 300,000 Units/ml Injectable; Injection Penicillin G Procaine 600,000 Units/1.2ml Injectable; Injection Penicillin G Procaine 300,000 Units/ml Injectable; Injection Pfizerpen G 100,000 Units Tablet; Oral
NewDrugInformation
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