Depodur

   
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Depodur


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

Dosage - INJECTABLE, LIPOSOMAL; EPIDURAL
The product dosage form and route separated by a semi-colon.

Active Ingredient(s) - Morphine Sulfate
Multiple ingredients are in alphabetical order.

Strength - 10MG/ML
The potency of the active ingredient(s), Morphine Sulfate. May repeat for multiple part products.

Applicant - SKYEPHARMA
The firm name holding legal responsibility for Depodur. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 021671
The FDA assigned number to Depodur. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Depodur. 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 - May 18, 2004
The date Depodur 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 Depodur. 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 Depodur is in. Format is RX, OTC, DISCN.

Applicant Full Name - Skyepharma Inc
The full name of the firm holding legal responsibility for the new application of Depodur.

Depodur