Galzin
Drug - Galzin
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) -
Zinc Acetate
Multiple ingredients are in alphabetical order.
Strength -
EQ 50MG ZINC
The potency of the active ingredient(s), Zinc Acetate. May repeat for multiple part products.
Applicant -
TEVA
The firm name holding legal responsibility for Galzin. The firm name is condensed to a maximum twenty character unique string.
New Drug Application (NDA) Number -
020458
The FDA assigned number to Galzin. Format is nnnnnn.
Product Number -
002
The FDA assigned number to identify Galzin. 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 -
Jan 28, 1997
The date Galzin 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 Galzin. 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 Galzin is in. Format is RX, OTC, DISCN.
Applicant Full Name -
Teva Pharmaceuticals Usa Inc
The full name of the firm holding legal responsibility for the new application of Galzin.
Galzin
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