Restasis
Drug - Restasis
The trade name of the product as shown on the labeling.
Dosage -
EMULSION; OPHTHALMIC
The product dosage form and route separated by a semi-colon.
Active Ingredient(s) -
Cyclosporine
Multiple ingredients are in alphabetical order.
Strength -
0.05%
The potency of the active ingredient(s), Cyclosporine. May repeat for multiple part products.
Applicant -
ALLERGAN
The firm name holding legal responsibility for Restasis. The firm name is condensed to a maximum twenty character unique string.
New Drug Application (NDA) Number -
050790
The FDA assigned number to Restasis. Format is nnnnnn.
Product Number -
001
The FDA assigned number to identify Restasis. 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 -
Dec 23, 2002
The date Restasis 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 Restasis. 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 Restasis is in. Format is RX, OTC, DISCN.
Applicant Full Name -
Allergan Inc
The full name of the firm holding legal responsibility for the new application of Restasis.
Restasis
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