Adderall Xr 5

   
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Adderall Xr 5


Drug - Adderall Xr 5
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 - 1.25MG;1.25MG;1.25MG;1.25MG
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 5. 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 5. Format is nnnnnn.

Product Number - 005
The FDA assigned number to identify Adderall Xr 5. 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 5 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 5. 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 5 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 5.

Adderall Xr 5


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Delcobese 1.25mg;1.25mg;1.25mg;1.25mg **federal Register Determination That Product Was Not Discontinued Or Withdrawn For Safety Or Efficacy Reasons** Tablet; Oral
Delcobese 2.5mg;2.5mg;2.5mg;2.5mg **federal Register Determination That Product Was Not Discontinued Or Withdrawn For Safety Or Efficacy Reasons** Tablet; Oral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