Climara

   
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Climara


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

Dosage - FILM, EXTENDED RELEASE; TRANSDERMAL
The product dosage form and route separated by a semi-colon.

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

Strength - 0.025MG/24HR
The potency of the active ingredient(s), Estradiol. May repeat for multiple part products.

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

New Drug Application (NDA) Number - 020375
The FDA assigned number to Climara. Format is nnnnnn.

Product Number - 004
The FDA assigned number to identify Climara. Each strength is a separate product. May repeat for multiple part products. Format is nnn.

Therapeutic Equivalence (TE) Code - AB2
The TE Code indicates the therapeutic equivalence rating of generic to innovator Rx products.

Approval Date - Mar 5, 1999
The date Climara 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 Climara. 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 Climara is in. Format is RX, OTC, DISCN.

Applicant Full Name - Berlex Inc
The full name of the firm holding legal responsibility for the new application of Climara.

Climara