Desmopressin Acetate (needs No Refrigeration)

   
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Desmopressin Acetate (needs No Refrigeration)


Drug - Desmopressin Acetate (needs No Refrigeration)
The trade name of the product as shown on the labeling.

Dosage - SPRAY, METERED; NASAL
The product dosage form and route separated by a semi-colon.

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

Strength - 0.01MG/SPRAY
The potency of the active ingredient(s), Desmopressin Acetate. May repeat for multiple part products.

Applicant - APOTEX
The firm name holding legal responsibility for Desmopressin Acetate (needs No Refrigeration). The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 076703
The FDA assigned number to Desmopressin Acetate (needs No Refrigeration). Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Desmopressin Acetate (needs No Refrigeration). Each strength is a separate product. May repeat for multiple part products. Format is nnn.

Therapeutic Equivalence (TE) Code - AB
The TE Code indicates the therapeutic equivalence rating of generic to innovator Rx products.

Approval Date - Jan 27, 2005
The date Desmopressin Acetate (needs No Refrigeration) 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 Desmopressin Acetate (needs No Refrigeration). 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 Desmopressin Acetate (needs No Refrigeration) is in. Format is RX, OTC, DISCN.

Applicant Full Name - Apotex Inc
The full name of the firm holding legal responsibility for the new application of Desmopressin Acetate (needs No Refrigeration).

Desmopressin Acetate (needs No Refrigeration)