Akne-mycin

   
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Akne-mycin


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

Dosage - OINTMENT; TOPICAL
The product dosage form and route separated by a semi-colon.

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

Strength - 2%
The potency of the active ingredient(s), Erythromycin. May repeat for multiple part products.

Applicant - HEALTHPOINT
The firm name holding legal responsibility for Akne-mycin. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 050584
The FDA assigned number to Akne-mycin. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Akne-mycin. 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 - Jan 10, 1985
The date Akne-mycin 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 Akne-mycin. 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 Akne-mycin is in. Format is RX, OTC, DISCN.

Applicant Full Name - Healthpoint Ltd
The full name of the firm holding legal responsibility for the new application of Akne-mycin.

Akne-mycin