Innopran Xl

   
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Innopran Xl


Drug - Innopran Xl
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) - Propranolol Hydrochloride
Multiple ingredients are in alphabetical order.

Strength - 80MG
The potency of the active ingredient(s), Propranolol Hydrochloride. May repeat for multiple part products.

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

New Drug Application (NDA) Number - 021438
The FDA assigned number to Innopran Xl. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Innopran Xl. Each strength is a separate product. May repeat for multiple part products. Format is nnn.

Therapeutic Equivalence (TE) Code - BX
The TE Code indicates the therapeutic equivalence rating of generic to innovator Rx products.

Approval Date - Mar 12, 2003
The date Innopran Xl 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 Innopran Xl. 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 Innopran Xl 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 Innopran Xl.

Innopran Xl