Infumorph

   
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Infumorph


Drug - Infumorph
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) - Morphine Sulfate
Multiple ingredients are in alphabetical order.

Strength - 25MG/ML
The potency of the active ingredient(s), Morphine Sulfate. May repeat for multiple part products.

Applicant - BAXTER HLTHCARE
The firm name holding legal responsibility for Infumorph. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 018565
The FDA assigned number to Infumorph. Format is nnnnnn.

Product Number - 004
The FDA assigned number to identify Infumorph. 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 - Jul 19, 1991
The date Infumorph 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 Infumorph. 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 Infumorph is in. Format is RX, OTC, DISCN.

Applicant Full Name - Baxter Healthcare Corp Anesthesia And Critical Care
The full name of the firm holding legal responsibility for the new application of Infumorph.

Infumorph