Axid Ar
Drug - Axid Ar
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) -
Nizatidine
Multiple ingredients are in alphabetical order.
Strength -
75MG
The potency of the active ingredient(s), Nizatidine. May repeat for multiple part products.
Applicant -
WYETH CONS
The firm name holding legal responsibility for Axid Ar. The firm name is condensed to a maximum twenty character unique string.
New Drug Application (NDA) Number -
020555
The FDA assigned number to Axid Ar. Format is nnnnnn.
Product Number -
001
The FDA assigned number to identify Axid Ar. 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 -
May 9, 1996
The date Axid Ar 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 Axid Ar. The RLD identifies the product Abbreviated New Drug Applications (ANDA) use as a reference. Format is Yes or No.
Type -
OTC
The group or category of approved drugs Axid Ar is in. Format is RX, OTC, DISCN.
Applicant Full Name -
Wyeth Consumer Healthcare
The full name of the firm holding legal responsibility for the new application of Axid Ar.
Axid Ar
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