Indomethacin
Drug - Indomethacin
The trade name of the product as shown on the labeling.
Dosage -
SUSPENSION; ORAL
The product dosage form and route separated by a semi-colon.
Active Ingredient(s) -
Indomethacin
Multiple ingredients are in alphabetical order.
Strength -
25MG/5ML
The potency of the active ingredient(s), Indomethacin. May repeat for multiple part products.
Applicant -
ROXANE
The firm name holding legal responsibility for Indomethacin. The firm name is condensed to a maximum twenty character unique string.
New Drug Application (NDA) Number -
071412
The FDA assigned number to Indomethacin. Format is nnnnnn.
Product Number -
001
The FDA assigned number to identify Indomethacin. 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 -
Mar 18, 1987
The date Indomethacin 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 Indomethacin. 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 Indomethacin is in. Format is RX, OTC, DISCN.
Applicant Full Name -
Roxane Laboratories Inc
The full name of the firm holding legal responsibility for the new application of Indomethacin.
Indomethacin
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