Lac-hydrin

   
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Lac-hydrin


Drug - Lac-hydrin
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 - WESTWOOD SQUIBB
The firm name holding legal responsibility for Lac-hydrin. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 019155
The FDA assigned number to Lac-hydrin. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Lac-hydrin. 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 - Apr 24, 1985
The date Lac-hydrin 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 Lac-hydrin. 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 Lac-hydrin is in. Format is RX, OTC, DISCN.

Applicant Full Name - Westwood Squibb Pharmaceuticals Inc
The full name of the firm holding legal responsibility for the new application of Lac-hydrin.

Lac-hydrin