Prilosec Otc

   
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Prilosec Otc


Drug - Prilosec Otc
The trade name of the product as shown on the labeling.

Dosage - TABLET, DELAYED RELEASE; ORAL
The product dosage form and route separated by a semi-colon.

Active Ingredient(s) - Omeprazole Magnesium
Multiple ingredients are in alphabetical order.

Strength - EQ 20MG BASE
The potency of the active ingredient(s), Omeprazole Magnesium. May repeat for multiple part products.

Applicant - ASTRAZENECA
The firm name holding legal responsibility for Prilosec Otc. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 021229
The FDA assigned number to Prilosec Otc. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Prilosec Otc. 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 - Jun 20, 2003
The date Prilosec Otc 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 Prilosec Otc. 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 Prilosec Otc is in. Format is RX, OTC, DISCN.

Applicant Full Name - Astrazeneca Lp
The full name of the firm holding legal responsibility for the new application of Prilosec Otc.

Prilosec Otc