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Orange Book product · Brand (NDA)

Adderall 15

Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate

Brand (NDA)NDA 011522DiscontinuedRLD Teva Womens
Approved
Aug 31, 2000
Application
Brand (NDA)
TE code
Not listed
Listed patents
0
Adderall 15 (Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate) is Teva Womens's brand-name drug, approved by the FDA under NDA 011522 in 2000. It is a reference-listed drug (RLD) — the approved product that generic ANDA applicants must show their version is equivalent to. Its marketing status is listed as discontinued; a discontinued listing is not, by itself, a finding that the drug was withdrawn for safety or effectiveness. 41 approved generics share this drug's active ingredient.

Sourced from the FDA Orange Book

Approval, patents, exclusivity

Key dates

Key dates

  1. Approval

    FDA approval date of this drug product.

    Aug 31, 2000

    26 yr 3 mo ago

  2. Today

FDA product record

Pharmaceutical detail

Pharmaceutical detail

Active ingredient

AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE

Strength

3.75MG;3.75MG;3.75MG;3.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Dosage form

TABLET

Route

ORAL

TE code

Not listed

Application

NDA 011522

Product number

013

Marketing status

Discontinued

Reference listed drug (RLD)

Yes

Reference standard (RS)

No

Same application

Other strengths in NDA 011522

Brand + generics

Active-ingredient family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

View full Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate family
Orange Book patent file

Listed patents

Listed patents

No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

Adderall 15 — frequently asked questions

Approval, therapeutic equivalence, patents, and exclusivity for this product, from the FDA Orange Book.

Built directly from the FDA Orange Book data file. This product page links back to the Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate active-ingredient family, which is the canonical reference for generics, patents, and exclusivity across all strengths.

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