Pamidronate Disodium

   
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Pamidronate Disodium


Drug - Pamidronate Disodium
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) - Pamidronate Disodium
Multiple ingredients are in alphabetical order.

Strength - 90MG /10ML(9MG/ML)
The potency of the active ingredient(s), Pamidronate Disodium. May repeat for multiple part products.

Applicant - SICOR PHARMS
The firm name holding legal responsibility for Pamidronate Disodium. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 076153
The FDA assigned number to Pamidronate Disodium. Format is nnnnnn.

Product Number - 002
The FDA assigned number to identify Pamidronate Disodium. 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 27, 2002
The date Pamidronate Disodium 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 Pamidronate Disodium. 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 Pamidronate Disodium is in. Format is RX, OTC, DISCN.

Applicant Full Name - Sicor Pharmaceuticals Inc
The full name of the firm holding legal responsibility for the new application of Pamidronate Disodium.

Pamidronate Disodium