Preven Emergency Contraceptive Kit

   
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Preven Emergency Contraceptive Kit


Drug - Preven Emergency Contraceptive Kit
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) - Ethinyl Estradiol; Levonorgestrel
Multiple ingredients are in alphabetical order.

Strength - 0.05MG;0.25MG
The potency of the active ingredient(s), Ethinyl Estradiol; Levonorgestrel. May repeat for multiple part products.

Applicant - DURAMED
The firm name holding legal responsibility for Preven Emergency Contraceptive Kit. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 020946
The FDA assigned number to Preven Emergency Contraceptive Kit. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Preven Emergency Contraceptive Kit. 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 - Sep 1, 1998
The date Preven Emergency Contraceptive Kit 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 Preven Emergency Contraceptive Kit. The RLD identifies the product Abbreviated New Drug Applications (ANDA) use as a reference. Format is Yes or No.

Type - DISCN
The group or category of approved drugs Preven Emergency Contraceptive Kit is in. Format is RX, OTC, DISCN.

Applicant Full Name - Duramed Pharmaceuticals Inc
The full name of the firm holding legal responsibility for the new application of Preven Emergency Contraceptive Kit.

Preven Emergency Contraceptive Kit