Isopto Cetamide

   
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Isopto Cetamide


Drug - Isopto Cetamide
The trade name of the product as shown on the labeling.

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

Active Ingredient(s) - Sulfacetamide Sodium
Multiple ingredients are in alphabetical order.

Strength - 15%
The potency of the active ingredient(s), Sulfacetamide Sodium. May repeat for multiple part products.

Applicant - ALCON
The firm name holding legal responsibility for Isopto Cetamide. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 080020
The FDA assigned number to Isopto Cetamide. Format is nnnnnn.

Product Number - 002
The FDA assigned number to identify Isopto Cetamide. Each strength is a separate product. May repeat for multiple part products. Format is nnn.

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

Approval Date - Approved Prior to Jan 1, 1982
The date Isopto Cetamide 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 Isopto Cetamide. 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 Isopto Cetamide is in. Format is RX, OTC, DISCN.

Applicant Full Name - Alcon Laboratories Inc
The full name of the firm holding legal responsibility for the new application of Isopto Cetamide.

Isopto Cetamide