Isoetharine Hcl

   
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Isoetharine Hcl


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

Dosage - SOLUTION; INHALATION
The product dosage form and route separated by a semi-colon.

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

Strength - 0.077%
The potency of the active ingredient(s), Isoetharine Hydrochloride. May repeat for multiple part products.

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

New Drug Application (NDA) Number - 086651
The FDA assigned number to Isoetharine Hcl. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Isoetharine Hcl. 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 - Approved Prior to Jan 1, 1982
The date Isoetharine 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 Isoetharine Hcl. 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 Isoetharine Hcl is in. Format is RX, OTC, DISCN.

Applicant Full Name - International Medication Systems Ltd
The full name of the firm holding legal responsibility for the new application of Isoetharine Hcl.

Isoetharine Hcl