Rythmol Sr

   
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Rythmol Sr


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

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

Active Ingredient(s) - Propafenone Hydrochloride
Multiple ingredients are in alphabetical order.

Strength - 225MG
The potency of the active ingredient(s), Propafenone Hydrochloride. May repeat for multiple part products.

Applicant - RELIANT PHARMS
The firm name holding legal responsibility for Rythmol Sr. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 021416
The FDA assigned number to Rythmol Sr. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Rythmol Sr. 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 4, 2003
The date Rythmol 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 Rythmol 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 Rythmol Sr is in. Format is RX, OTC, DISCN.

Applicant Full Name - Reliant Pharmaceuticals Llc
The full name of the firm holding legal responsibility for the new application of Rythmol Sr.

Rythmol Sr