Temaz
Drug - Temaz
The trade name of the product as shown on the labeling.
Dosage -
CAPSULE; ORAL
The product dosage form and route separated by a semi-colon.
Active Ingredient(s) -
Temazepam
Multiple ingredients are in alphabetical order.
Strength -
15MG
The potency of the active ingredient(s), Temazepam. May repeat for multiple part products.
Applicant -
QUANTUM PHARMICS
The firm name holding legal responsibility for Temaz. The firm name is condensed to a maximum twenty character unique string.
New Drug Application (NDA) Number -
070564
The FDA assigned number to Temaz. Format is nnnnnn.
Product Number -
001
The FDA assigned number to identify Temaz. 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 15, 1985
The date Temaz 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 Temaz. 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 Temaz is in. Format is RX, OTC, DISCN.
Applicant Full Name -
Quantum Pharmics Ltd
The full name of the firm holding legal responsibility for the new application of Temaz.
Temaz
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