Coactin

   
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Coactin


Drug - Coactin
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) - Amdinocillin
Multiple ingredients are in alphabetical order.

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

Applicant - ROCHE
The firm name holding legal responsibility for Coactin. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 050565
The FDA assigned number to Coactin. Format is nnnnnn.

Product Number - 002
The FDA assigned number to identify Coactin. 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 - Dec 21, 1984
The date Coactin 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 Coactin. 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 Coactin is in. Format is RX, OTC, DISCN.

Applicant Full Name - Hoffmann La Roche Inc
The full name of the firm holding legal responsibility for the new application of Coactin.

Coactin