Ampicillin And Sulbactam

   
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Ampicillin And Sulbactam


Drug - Ampicillin And Sulbactam
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) - Ampicillin Sodium; Sulbactam Sodium
Multiple ingredients are in alphabetical order.

Strength - EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL
The potency of the active ingredient(s), Ampicillin Sodium; Sulbactam Sodium. May repeat for multiple part products.

Applicant - BAXTER HLTHCARE
The firm name holding legal responsibility for Ampicillin And Sulbactam. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 065076
The FDA assigned number to Ampicillin And Sulbactam. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Ampicillin And Sulbactam. Each strength is a separate product. May repeat for multiple part products. Format is nnn.

Therapeutic Equivalence (TE) Code - AP
The TE Code indicates the therapeutic equivalence rating of generic to innovator Rx products.

Approval Date - Mar 19, 2002
The date Ampicillin And Sulbactam 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 Ampicillin And Sulbactam. 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 Ampicillin And Sulbactam is in. Format is RX, OTC, DISCN.

Applicant Full Name - Baxter Healthcare Corp Anesthesia And Critical Care
The full name of the firm holding legal responsibility for the new application of Ampicillin And Sulbactam.

Ampicillin And Sulbactam