Osmitrol 5% In Water

   
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Osmitrol 5% In Water


Drug - Osmitrol 5% In Water
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) - Mannitol
Multiple ingredients are in alphabetical order.

Strength - 5GM/100ML
The potency of the active ingredient(s), Mannitol. May repeat for multiple part products.

Applicant - BAXTER HLTHCARE
The firm name holding legal responsibility for Osmitrol 5% In Water. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 013684
The FDA assigned number to Osmitrol 5% In Water. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Osmitrol 5% In Water. 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 Osmitrol 5% In Water 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 Osmitrol 5% In Water. 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 Osmitrol 5% In Water is in. Format is RX, OTC, DISCN.

Applicant Full Name - Baxter Healthcare Corp
The full name of the firm holding legal responsibility for the new application of Osmitrol 5% In Water.

Osmitrol 5% In Water