Indocin I.V.

   
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Indocin I.V.


Drug - Indocin I.V.
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) - Indomethacin Sodium
Multiple ingredients are in alphabetical order.

Strength - EQ 1MG BASE/VIAL
The potency of the active ingredient(s), Indomethacin Sodium. May repeat for multiple part products.

Applicant - OVATION PHARMS
The firm name holding legal responsibility for Indocin I.V.. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 018878
The FDA assigned number to Indocin I.V.. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Indocin I.V.. 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 30, 1985
The date Indocin I.V. 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 Indocin I.V.. 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 Indocin I.V. is in. Format is RX, OTC, DISCN.

Applicant Full Name - Ovation Pharmaceuticals Inc
The full name of the firm holding legal responsibility for the new application of Indocin I.V..

Indocin I.V.