Pentetate Calcium Trisodium

   
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Pentetate Calcium Trisodium


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

Dosage - SOLUTION; INHALATION, INTRAVENOUS
The product dosage form and route separated by a semi-colon.

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

Strength - EQ 1GM/5ML(EQ 200MG/ML)
The potency of the active ingredient(s), Pentetate Calcium Trisodium. May repeat for multiple part products.

Applicant - HAMELN PHARMS
The firm name holding legal responsibility for Pentetate Calcium Trisodium. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 021749
The FDA assigned number to Pentetate Calcium Trisodium. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Pentetate Calcium Trisodium. 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 - Aug 11, 2004
The date Pentetate Calcium Trisodium 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 Pentetate Calcium Trisodium. 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 Pentetate Calcium Trisodium is in. Format is RX, OTC, DISCN.

Applicant Full Name - Hameln Pharmaceuticals Gmbh
The full name of the firm holding legal responsibility for the new application of Pentetate Calcium Trisodium.

Pentetate Calcium Trisodium