Dobutamine Hcl


Dobutamine Hcl

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

The product dosage form and route separated by a semi-colon.

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

Strength - EQ 1.25GM BASE/100ML
The potency of the active ingredient(s), Dobutamine Hydrochloride. May repeat for multiple part products.

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

New Drug Application (NDA) Number - 074634
The FDA assigned number to Dobutamine Hcl. Format is nnnnnn.

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

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

Approval Date - Sep 27, 1996
The date Dobutamine 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 Dobutamine 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 Dobutamine Hcl is in. Format is RX, OTC, DISCN.

Applicant Full Name - Hospira Inc
The full name of the firm holding legal responsibility for the new application of Dobutamine Hcl.

Dobutamine Hcl