Dynacirc Cr
Drug - Dynacirc Cr
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) -
Isradipine
Multiple ingredients are in alphabetical order.
Strength -
10MG
The potency of the active ingredient(s), Isradipine. May repeat for multiple part products.
Applicant -
RELIANT PHARMS
The firm name holding legal responsibility for Dynacirc Cr. The firm name is condensed to a maximum twenty character unique string.
New Drug Application (NDA) Number -
020336
The FDA assigned number to Dynacirc Cr. Format is nnnnnn.
Product Number -
002
The FDA assigned number to identify Dynacirc Cr. 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 -
Jun 1, 1994
The date Dynacirc Cr 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 Dynacirc Cr. 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 Dynacirc Cr 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 Dynacirc Cr.
Dynacirc Cr
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