Adderall Xr 30

   
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Adderall Xr 30


Drug - Adderall Xr 30
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 - 7.5MG;7.5MG;7.5MG;7.5MG
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 30. 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 30. Format is nnnnnn.

Product Number - 003
The FDA assigned number to identify Adderall Xr 30. 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 - Oct 11, 2001
The date Adderall Xr 30 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 Adderall Xr 30. 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 30 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 30.

Adderall Xr 30


Adderall Xr 20 5mg;5mg;5mg;5mg Capsule, Extended Release; Oral
Adderall Xr 25 6.25mg;6.25mg;6.25mg;6.25mg Capsule, Extended Release; Oral
Adderall Xr 30 7.5mg;7.5mg;7.5mg;7.5mg Capsule, Extended Release; 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Delcobese 5mg;5mg;5mg;5mg **federal Register Determination That Product Was Not Discontinued Or Withdrawn For Safety Or Efficacy Reasons** Capsule; Oral
Delcobese 1.25mg;1.25mg;1.25mg;1.25mg **federal Register Determination That Product Was Not Discontinued Or Withdrawn For Safety Or Efficacy Reasons** Tablet; Oral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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