Oramorph Sr
Drug - Oramorph Sr
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 -
30MG
The potency of the active ingredient(s), Morphine Sulfate. May repeat for multiple part products.
Applicant -
XANODYNE PHARM
The firm name holding legal responsibility for Oramorph Sr. The firm name is condensed to a maximum twenty character unique string.
New Drug Application (NDA) Number -
019977
The FDA assigned number to Oramorph Sr. Format is nnnnnn.
Product Number -
001
The FDA assigned number to identify Oramorph Sr. Each strength is a separate product. May repeat for multiple part products. Format is nnn.
Therapeutic Equivalence (TE) Code -
BC
The TE Code indicates the therapeutic equivalence rating of generic to innovator Rx products.
Approval Date -
Aug 15, 1991
The date Oramorph Sr 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 Oramorph Sr. 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 Oramorph Sr is in. Format is RX, OTC, DISCN.
Applicant Full Name -
Xanodyne Pharmacal Inc
The full name of the firm holding legal responsibility for the new application of Oramorph Sr.
Oramorph Sr
Ms Contin 30mg Tablet, Extended Release; Oral Ms Contin 60mg Tablet, Extended Release; Oral Oramorph Sr 100mg Tablet, Extended Release; Oral Oramorph Sr 15mg Tablet, Extended Release; Oral Oramorph Sr 30mg Tablet, Extended Release; Oral Morphine Sulfate 60mg Tablet, Extended Release; Oral Morphine Sulfate 100mg Tablet, Extended Release; Oral Ms Contin 100mg Tablet, Extended Release; Oral Ms Contin 15mg Tablet, Extended Release; Oral Ms Contin 200mg Tablet, Extended Release; Oral
NewDrugInformation
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