Pred-g

   
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Pred-g


Drug - Pred-g
The trade name of the product as shown on the labeling.

Dosage - SUSPENSION/DROPS; OPHTHALMIC
The product dosage form and route separated by a semi-colon.

Active Ingredient(s) - Gentamicin Sulfate; Prednisolone Acetate
Multiple ingredients are in alphabetical order.

Strength - EQ 0.3% BASE;1%
The potency of the active ingredient(s), Gentamicin Sulfate; Prednisolone Acetate. May repeat for multiple part products.

Applicant - ALLERGAN
The firm name holding legal responsibility for Pred-g. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 050586
The FDA assigned number to Pred-g. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Pred-g. 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 - Jun 10, 1988
The date Pred-g 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 Pred-g. 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 Pred-g is in. Format is RX, OTC, DISCN.

Applicant Full Name - Allergan Pharmaceutical
The full name of the firm holding legal responsibility for the new application of Pred-g.

Pred-g