Grisactin Ultra

   
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Grisactin Ultra


Drug - Grisactin Ultra
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) - Griseofulvin, Ultramicrocrystalline
Multiple ingredients are in alphabetical order.

Strength - 125MG
The potency of the active ingredient(s), Griseofulvin, Ultramicrocrystalline. May repeat for multiple part products.

Applicant - WYETH AYERST
The firm name holding legal responsibility for Grisactin Ultra. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 062178
The FDA assigned number to Grisactin Ultra. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Grisactin Ultra. 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 Grisactin Ultra 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 Grisactin Ultra. 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 Grisactin Ultra is in. Format is RX, OTC, DISCN.

Applicant Full Name - Wyeth Ayerst Laboratories
The full name of the firm holding legal responsibility for the new application of Grisactin Ultra.

Grisactin Ultra