Renormax

   
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Renormax


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

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

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

Strength - 6MG
The potency of the active ingredient(s), Spirapril Hydrochloride. May repeat for multiple part products.

Applicant - SCHERING
The firm name holding legal responsibility for Renormax. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 020240
The FDA assigned number to Renormax. Format is nnnnnn.

Product Number - 002
The FDA assigned number to identify Renormax. 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 - Dec 29, 1994
The date Renormax 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 Renormax. The RLD identifies the product Abbreviated New Drug Applications (ANDA) use as a reference. Format is Yes or No.

Type - DISCN
The group or category of approved drugs Renormax is in. Format is RX, OTC, DISCN.

Applicant Full Name - Schering Corp
The full name of the firm holding legal responsibility for the new application of Renormax.

Renormax