Elmiron

   
Google
 
Web NewDrugInformation.com

Elmiron


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

Dosage - CAPSULE; ORAL
The product dosage form and route separated by a semi-colon.

Active Ingredient(s) - Pentosan Polysulfate Sodium
Multiple ingredients are in alphabetical order.

Strength - 100MG
The potency of the active ingredient(s), Pentosan Polysulfate Sodium. May repeat for multiple part products.

Applicant - ORTHO MCNEIL PHARM
The firm name holding legal responsibility for Elmiron. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 020193
The FDA assigned number to Elmiron. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Elmiron. 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 - Sep 26, 1996
The date Elmiron 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 Elmiron. 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 Elmiron is in. Format is RX, OTC, DISCN.

Applicant Full Name - Ortho Mcneil Pharmaceutical Inc
The full name of the firm holding legal responsibility for the new application of Elmiron.

Elmiron