Dexamethasone

   
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Dexamethasone


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

Dosage - INJECTABLE; INJECTION
The product dosage form and route separated by a semi-colon.

Active Ingredient(s) - Dexamethasone Sodium Phosphate
Multiple ingredients are in alphabetical order.

Strength - EQ 10MG PHOSPHATE/ML
The potency of the active ingredient(s), Dexamethasone Sodium Phosphate. May repeat for multiple part products.

Applicant - AM PHARM PARTNERS
The firm name holding legal responsibility for Dexamethasone. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 088469
The FDA assigned number to Dexamethasone. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Dexamethasone. 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 25, 1984
The date Dexamethasone 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 Dexamethasone. 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 Dexamethasone is in. Format is RX, OTC, DISCN.

Applicant Full Name - American Pharmaceutical Partners Inc
The full name of the firm holding legal responsibility for the new application of Dexamethasone.

Dexamethasone