Isoptin Sr

   
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Isoptin Sr


Drug - Isoptin Sr
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) - Verapamil Hydrochloride
Multiple ingredients are in alphabetical order.

Strength - 240MG
The potency of the active ingredient(s), Verapamil Hydrochloride. May repeat for multiple part products.

Applicant - PAR PHARM
The firm name holding legal responsibility for Isoptin Sr. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 019152
The FDA assigned number to Isoptin Sr. Format is nnnnnn.

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

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

Approval Date - Dec 16, 1986
The date Isoptin 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) - Yes
The pioneer or innovator of Isoptin 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 Isoptin Sr is in. Format is RX, OTC, DISCN.

Applicant Full Name - Par Pharmaceutical Inc
The full name of the firm holding legal responsibility for the new application of Isoptin Sr.

Isoptin Sr