Adderall Xr 15

   
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Adderall Xr 15


Drug - Adderall Xr 15
The trade name of the product as shown on the labeling.

Dosage - CAPSULE, EXTENDED RELEASE; ORAL
The product dosage form and route separated by a semi-colon.

Active Ingredient(s) - Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate
Multiple ingredients are in alphabetical order.

Strength - 3.75MG;3.75MG;3.75MG;3.75MG
The potency of the active ingredient(s), Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate. May repeat for multiple part products.

Applicant - SHIRE
The firm name holding legal responsibility for Adderall Xr 15. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 021303
The FDA assigned number to Adderall Xr 15. Format is nnnnnn.

Product Number - 006
The FDA assigned number to identify Adderall Xr 15. 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 - May 22, 2002
The date Adderall Xr 15 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 Adderall Xr 15. 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 Adderall Xr 15 is in. Format is RX, OTC, DISCN.

Applicant Full Name - Shire Development Inc
The full name of the firm holding legal responsibility for the new application of Adderall Xr 15.

Adderall Xr 15


Delcobese 1.25mg;1.25mg;1.25mg;1.25mg **federal Register Determination That Product Was Not Discontinued Or Withdrawn For Safety Or Efficacy Reasons** Capsule; Oral
Delcobese 2.5mg;2.5mg;2.5mg;2.5mg **federal Register Determination That Product Was Not Discontinued Or Withdrawn For Safety Or Efficacy Reasons** Capsule; Oral
Delcobese 3.75mg;3.75mg;3.75mg;3.75mg **federal Register Determination That Product Was Not Discontinued Or Withdrawn For Safety Or Efficacy Reasons** Capsule; Oral
Delcobese 5mg;5mg;5mg;5mg **federal Register Determination That Product Was Not Discontinued Or Withdrawn For Safety Or Efficacy Reasons** Capsule; Oral
Delcobese 1.25mg;1.25mg;1.25mg;1.25mg **federal Register Determination That Product Was Not Discontinued Or Withdrawn For Safety Or Efficacy Reasons** Tablet; Oral
Delcobese 2.5mg;2.5mg;2.5mg;2.5mg **federal Register Determination That Product Was Not Discontinued Or Withdrawn For Safety Or Efficacy Reasons** Tablet; Oral
Delcobese 3.75mg;3.75mg;3.75mg;3.75mg **federal Register Determination That Product Was Not Discontinued Or Withdrawn For Safety Or Efficacy Reasons** Tablet; Oral
Delcobese 5mg;5mg;5mg;5mg **federal Register Determination That Product Was Not Discontinued Or Withdrawn For Safety Or Efficacy Reasons** Tablet; Oral
Adderall Xr 10 2.5mg;2.5mg;2.5mg;2.5mg Capsule, Extended Release; Oral
Adderall Xr 15 3.75mg;3.75mg;3.75mg;3.75mg Capsule, Extended Release; Oral

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