Ammonium Lactate

   
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Ammonium Lactate


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

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

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

Strength - EQ 12% BASE
The potency of the active ingredient(s), Ammonium Lactate. May repeat for multiple part products.

Applicant - PADDOCK
The firm name holding legal responsibility for Ammonium Lactate. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 075575
The FDA assigned number to Ammonium Lactate. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Ammonium Lactate. 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 - Jun 11, 2002
The date Ammonium Lactate 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 Ammonium Lactate. 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 Ammonium Lactate is in. Format is RX, OTC, DISCN.

Applicant Full Name - Paddock Laboratories Inc
The full name of the firm holding legal responsibility for the new application of Ammonium Lactate.

Ammonium Lactate