Cis-mdp

   
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Cis-mdp


Drug - Cis-mdp
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) - Technetium Tc-99m Medronate Kit
Multiple ingredients are in alphabetical order.

Strength - N/A
The potency of the active ingredient(s), Technetium Tc-99m Medronate Kit. May repeat for multiple part products.

Applicant - CIS
The firm name holding legal responsibility for Cis-mdp. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 018124
The FDA assigned number to Cis-mdp. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Cis-mdp. 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 Cis-mdp 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 Cis-mdp. 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 Cis-mdp is in. Format is RX, OTC, DISCN.

Applicant Full Name - Cis Us Inc
The full name of the firm holding legal responsibility for the new application of Cis-mdp.

Cis-mdp