Unisom

   
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Unisom


Drug - Unisom
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) - Doxylamine Succinate
Multiple ingredients are in alphabetical order.

Strength - 25MG
The potency of the active ingredient(s), Doxylamine Succinate. May repeat for multiple part products.

Applicant - PFIZER
The firm name holding legal responsibility for Unisom. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 018066
The FDA assigned number to Unisom. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Unisom. 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 - Approved Prior to Jan 1, 1982
The date Unisom 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 Unisom. 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 Unisom is in. Format is RX, OTC, DISCN.

Applicant Full Name - Pfizer Laboratories Div Pfizer Inc
The full name of the firm holding legal responsibility for the new application of Unisom.

Unisom