Oragrafin Calcium

   
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Oragrafin Calcium


Drug - Oragrafin Calcium
The trade name of the product as shown on the labeling.

Dosage - GRANULE; ORAL
The product dosage form and route separated by a semi-colon.

Active Ingredient(s) - Ipodate Calcium
Multiple ingredients are in alphabetical order.

Strength - 3GM/PACKET
The potency of the active ingredient(s), Ipodate Calcium. May repeat for multiple part products.

Applicant - BRACCO
The firm name holding legal responsibility for Oragrafin Calcium. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 012968
The FDA assigned number to Oragrafin Calcium. Format is nnnnnn.

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

Applicant Full Name - Bracco Diagnostics Inc
The full name of the firm holding legal responsibility for the new application of Oragrafin Calcium.

Oragrafin Calcium