Morphine Sulfate

   
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Morphine Sulfate


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

Dosage - TABLET, EXTENDED RELEASE; ORAL
The product dosage form and route separated by a semi-colon.

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

Strength - 60MG
The potency of the active ingredient(s), Morphine Sulfate. May repeat for multiple part products.

Applicant - MALLINCKRODT
The firm name holding legal responsibility for Morphine Sulfate. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 076412
The FDA assigned number to Morphine Sulfate. Format is nnnnnn.

Product Number - 003
The FDA assigned number to identify Morphine Sulfate. 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 - Jul 31, 2003
The date Morphine Sulfate 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 Morphine Sulfate. 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 Morphine Sulfate is in. Format is RX, OTC, DISCN.

Applicant Full Name - Mallinckrodt Inc
The full name of the firm holding legal responsibility for the new application of Morphine Sulfate.

Morphine Sulfate