Minirin

   
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Minirin


Drug - Minirin
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 - FERRING
The firm name holding legal responsibility for Minirin. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 021333
The FDA assigned number to Minirin. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Minirin. 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 - Sep 16, 2002
The date Minirin 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 Minirin. 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 Minirin is in. Format is RX, OTC, DISCN.

Applicant Full Name - Ferring Pharmaceuticals Inc
The full name of the firm holding legal responsibility for the new application of Minirin.

Minirin