Diltiazem Hcl

   
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Diltiazem Hcl


Drug - Diltiazem Hcl
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) - Diltiazem Hydrochloride
Multiple ingredients are in alphabetical order.

Strength - 60MG
The potency of the active ingredient(s), Diltiazem Hydrochloride. May repeat for multiple part products.

Applicant - MYLAN
The firm name holding legal responsibility for Diltiazem Hcl. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 073186
The FDA assigned number to Diltiazem Hcl. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Diltiazem Hcl. 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 - Nov 5, 1992
The date Diltiazem Hcl 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 Diltiazem Hcl. 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 Diltiazem Hcl is in. Format is RX, OTC, DISCN.

Applicant Full Name - Mylan Pharmaceuticals Inc
The full name of the firm holding legal responsibility for the new application of Diltiazem Hcl.

Diltiazem Hcl