Junel Fe 1.5/30

   
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Junel Fe 1.5/30


Drug - Junel Fe 1.5/30
The trade name of the product as shown on the labeling.

Dosage - TABLET; ORAL-28
The product dosage form and route separated by a semi-colon.

Active Ingredient(s) - Ethinyl Estradiol; Norethindrone Acetate
Multiple ingredients are in alphabetical order.

Strength - 0.03MG;1.5MG
The potency of the active ingredient(s), Ethinyl Estradiol; Norethindrone Acetate. May repeat for multiple part products.

Applicant - BARR
The firm name holding legal responsibility for Junel Fe 1.5/30. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 076064
The FDA assigned number to Junel Fe 1.5/30. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Junel Fe 1.5/30. Each strength is a separate product. May repeat for multiple part products. Format is nnn.

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

Approval Date - Sep 18, 2003
The date Junel Fe 1.5/30 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) - No
The pioneer or innovator of Junel Fe 1.5/30. 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 Junel Fe 1.5/30 is in. Format is RX, OTC, DISCN.

Applicant Full Name - Barr Laboratories Inc
The full name of the firm holding legal responsibility for the new application of Junel Fe 1.5/30.

Junel Fe 1.5/30