Penicillin G Sodium
Drug - Penicillin G Sodium
The trade name of the product as shown on the labeling.
Dosage -
INJECTABLE; IM-IV
The product dosage form and route separated by a semi-colon.
Active Ingredient(s) -
Penicillin G Sodium
Multiple ingredients are in alphabetical order.
Strength -
5,000,000 UNITS/VIAL
The potency of the active ingredient(s), Penicillin G Sodium. May repeat for multiple part products.
Applicant -
BIOCHEMIE
The firm name holding legal responsibility for Penicillin G Sodium. The firm name is condensed to a maximum twenty character unique string.
New Drug Application (NDA) Number -
065068
The FDA assigned number to Penicillin G Sodium. Format is nnnnnn.
Product Number -
001
The FDA assigned number to identify Penicillin G Sodium. 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 -
Feb 26, 2001
The date Penicillin G Sodium 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 Sodium. 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 Sodium is in. Format is RX, OTC, DISCN.
Applicant Full Name -
Biochemie Gmbh
The full name of the firm holding legal responsibility for the new application of Penicillin G Sodium.
Penicillin G Sodium
Penicillin G Procaine 300,000 Units/ml Injectable; Injection Penicillin G Procaine 1,500,000 Units/vial Injectable; Injection Penicillin G Procaine 300,000 Units/vial Injectable; Injection Pfizerpen-as 300,000 Units/ml Injectable; Injection Pfizerpen-as 600,000 Units/ml Injectable; Injection Penicillin G Sodium 5,000,000 Units/vial Injectable; Im-iv 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 Penicillin G Procaine 600,000 Units/ml Injectable; Injection
NewDrugInformation
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