Ampicillin Sodium

   
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Ampicillin Sodium


Drug - Ampicillin Sodium
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
Multiple ingredients are in alphabetical order.

Strength - EQ 500MG BASE/VIAL
The potency of the active ingredient(s), Ampicillin Sodium. May repeat for multiple part products.

Applicant - SANDOZ
The firm name holding legal responsibility for Ampicillin Sodium. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 061395
The FDA assigned number to Ampicillin Sodium. Format is nnnnnn.

Product Number - 003
The FDA assigned number to identify Ampicillin Sodium. 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 - Approved Prior to Jan 1, 1982
The date Ampicillin 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 Ampicillin 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 Ampicillin Sodium is in. Format is RX, OTC, DISCN.

Applicant Full Name - Sandoz Inc
The full name of the firm holding legal responsibility for the new application of Ampicillin Sodium.

Ampicillin Sodium