Nephramine 5.4%

   
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Nephramine 5.4%


Drug - Nephramine 5.4%
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) - Amino Acids
Multiple ingredients are in alphabetical order.

Strength - 5.4% (5.4GM/100ML)
The potency of the active ingredient(s), Amino Acids. May repeat for multiple part products.

Applicant - B BRAUN
The firm name holding legal responsibility for Nephramine 5.4%. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 017766
The FDA assigned number to Nephramine 5.4%. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Nephramine 5.4%. 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 Nephramine 5.4% 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 Nephramine 5.4%. 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 Nephramine 5.4% is in. Format is RX, OTC, DISCN.

Applicant Full Name - B Braun Medical Inc
The full name of the firm holding legal responsibility for the new application of Nephramine 5.4%.

Nephramine 5.4%