Phoslo Gelcaps

   
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Phoslo Gelcaps


Drug - Phoslo Gelcaps
The trade name of the product as shown on the labeling.

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

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

Strength - EQ 169MG CALCIUM
The potency of the active ingredient(s), Calcium Acetate. May repeat for multiple part products.

Applicant - NABI
The firm name holding legal responsibility for Phoslo Gelcaps. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 021160
The FDA assigned number to Phoslo Gelcaps. Format is nnnnnn.

Product Number - 003
The FDA assigned number to identify Phoslo Gelcaps. 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 - Apr 2, 2001
The date Phoslo Gelcaps 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 Phoslo Gelcaps. 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 Phoslo Gelcaps is in. Format is RX, OTC, DISCN.

Applicant Full Name - Nabi Biopharmaceuticals
The full name of the firm holding legal responsibility for the new application of Phoslo Gelcaps.

Phoslo Gelcaps