Penicillin-2
Drug - Penicillin-2
The trade name of the product as shown on the labeling.
Dosage -
FOR SOLUTION; ORAL
The product dosage form and route separated by a semi-colon.
Active Ingredient(s) -
Penicillin G Potassium
Multiple ingredients are in alphabetical order.
Strength -
250,000 UNITS/5ML
The potency of the active ingredient(s), Penicillin G Potassium. May repeat for multiple part products.
Applicant -
TEVA
The firm name holding legal responsibility for Penicillin-2. The firm name is condensed to a maximum twenty character unique string.
New Drug Application (NDA) Number -
060307
The FDA assigned number to Penicillin-2. Format is nnnnnn.
Product Number -
003
The FDA assigned number to identify Penicillin-2. 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-2 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 Penicillin-2. 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 Penicillin-2 is in. Format is RX, OTC, DISCN.
Applicant Full Name -
Teva Pharmaceuticals Usa Inc
The full name of the firm holding legal responsibility for the new application of Penicillin-2.
Penicillin-2
Penicillin G Potassium 400,000 Units/5ml For Solution; Oral Penicillin-2 250,000 Units/5ml For Solution; Oral Bicillin C-r 300,000 Units/ml;300,000 Units/ml Injectable; Injection Bicillin C-r 900/300 900,000 Units/2ml;300,000 Units/2ml Injectable; Injection Penicillin 200,000 Units/5ml For Solution; Oral Penicillin 400,000 Units/5ml For Solution; Oral Penicillin G Potassium 200,000 Units/5ml For Solution; Oral Penicillin G Potassium 250,000 Units/5ml For Solution; Oral Penicillin G Potassium 400,000 Units/5ml For Solution; Oral Penicillin G Potassium 250,000 Units/5ml For Solution; Oral
NewDrugInformation
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