Mykrox
Drug - Mykrox
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) -
Metolazone
Multiple ingredients are in alphabetical order.
Strength -
0.5MG
The potency of the active ingredient(s), Metolazone. May repeat for multiple part products.
Applicant -
UCB
The firm name holding legal responsibility for Mykrox. The firm name is condensed to a maximum twenty character unique string.
New Drug Application (NDA) Number -
019532
The FDA assigned number to Mykrox. Format is nnnnnn.
Product Number -
001
The FDA assigned number to identify Mykrox. 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 -
Oct 30, 1987
The date Mykrox 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 Mykrox. 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 Mykrox is in. Format is RX, OTC, DISCN.
Applicant Full Name -
Ucb Pharma Inc
The full name of the firm holding legal responsibility for the new application of Mykrox.
Mykrox
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