Delcobese

   
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Delcobese


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

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

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

Strength - 5MG;5MG;5MG;5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
The potency of the active ingredient(s), Amphetamine Adipate; Amphetamine Sulfate; Dextroamphetamine Adipate; Dextroamphetamine Sulfate. May repeat for multiple part products.

Applicant - TEVA
The firm name holding legal responsibility for Delcobese. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 083564
The FDA assigned number to Delcobese. Format is nnnnnn.

Product Number - 004
The FDA assigned number to identify Delcobese. 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 - Approved Prior to Jan 1, 1982
The date Delcobese 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 Delcobese. 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 Delcobese is in. Format is RX, OTC, DISCN.

Applicant Full Name - Teva Pharmaceuticals Usa Inc
The full name of the firm holding legal responsibility for the new application of Delcobese.

Delcobese


Delcobese 1.25mg;1.25mg;1.25mg;1.25mg **federal Register Determination That Product Was Not Discontinued Or Withdrawn For Safety Or Efficacy Reasons** Capsule; Oral
Delcobese 2.5mg;2.5mg;2.5mg;2.5mg **federal Register Determination That Product Was Not Discontinued Or Withdrawn For Safety Or Efficacy Reasons** Capsule; Oral
Delcobese 3.75mg;3.75mg;3.75mg;3.75mg **federal Register Determination That Product Was Not Discontinued Or Withdrawn For Safety Or Efficacy Reasons** Capsule; Oral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
Amoxicillin And Clavulanate Potassium 875mg;eq 125mg Base Tablet; Oral
Amoxicillin And Clavulanate Potassium 500mg;eq 125mg Base Tablet; Oral
Amoxicillin And Clavulanate Potassium 875mg;eq 125mg Base Tablet; Oral
Augmentin '250' 250mg;eq 125mg Base Tablet; Oral
Augmentin '500' 500mg;eq 125mg Base Tablet; Oral
Augmentin '875' 875mg;eq 125mg Base Tablet; Oral

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