N.E.E. 1/35 28

   
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N.E.E. 1/35 28


Drug - N.E.E. 1/35 28
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
Multiple ingredients are in alphabetical order.

Strength - 0.035MG;1MG
The potency of the active ingredient(s), Ethinyl Estradiol; Norethindrone. May repeat for multiple part products.

Applicant - LPI
The firm name holding legal responsibility for N.E.E. 1/35 28. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 071542
The FDA assigned number to N.E.E. 1/35 28. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify N.E.E. 1/35 28. 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 - Dec 14, 1987
The date N.E.E. 1/35 28 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 N.E.E. 1/35 28. 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 N.E.E. 1/35 28 is in. Format is RX, OTC, DISCN.

Applicant Full Name - Lpi Holdings Inc
The full name of the firm holding legal responsibility for the new application of N.E.E. 1/35 28.

N.E.E. 1/35 28