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Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Tablets,CII

Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Tablets, 20 mg,Cll · Tablet

Prescription ANDA Schedule CII TE AB
Informational index, not medical advice. Content is reproduced from public FDA and NLM data. Always confirm against the manufacturer's current prescribing information. Report adverse events to FDA MedWatch.

Overview

Brand name
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Tablets,CII
Generic name
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Tablets, 20 mg,Cll
Dosage form
Tablet
Route
Oral
Marketing category
ANDA · ANDA
Labeler
Alvogen Inc.
Product type
Human Prescription Drug
DEA schedule
CII
Active ingredients
20
NDC product codes
5
Packages
5
Data completeness
60% of corroborating sources present

Active ingredients

Source: NDC Directory
Active ingredients and strengths as listed in the NDC Directory.
Ingredient Strength RxCUI Monograph
Amphetamine Aspartate Monohydrate 1.25 mg/1 861221 View
Amphetamine Aspartate Monohydrate 2.5 mg/1 861221 View
Amphetamine Aspartate Monohydrate 3.75 mg/1 861221 View
Amphetamine Aspartate Monohydrate 5 mg/1 861221 View
Amphetamine Aspartate Monohydrate 7.5 mg/1 861221 View
Amphetamine Sulfate 1.25 mg/1 884655 View
Amphetamine Sulfate 2.5 mg/1 884655 View
Amphetamine Sulfate 3.75 mg/1 884655 View
Amphetamine Sulfate 5 mg/1 884655 View
Amphetamine Sulfate 7.5 mg/1 884655 View
Dextroamphetamine Saccharate 1.25 mg/1 861221 View
Dextroamphetamine Saccharate 2.5 mg/1 861221 View
Dextroamphetamine Saccharate 3.75 mg/1 861221 View
Dextroamphetamine Saccharate 5 mg/1 861221 View
Dextroamphetamine Saccharate 7.5 mg/1 861221 View
Dextroamphetamine Sulfate 1.25 mg/1 884385 View
Dextroamphetamine Sulfate 2.5 mg/1 884385 View
Dextroamphetamine Sulfate 3.75 mg/1 884385 View
Dextroamphetamine Sulfate 5 mg/1 884385 View
Dextroamphetamine Sulfate 7.5 mg/1 884385 View

Forms, strengths and routes

Source: NDC Directory
Dosage form
Tablet
Route of administration
Oral
Presentations
10

Pharmacologic classes are listed in the class section below.

Pharmacologic class

Source: NDC Directory
Established pharmacologic classes (EPC), mechanisms of action (MoA), chemical structures (CS) and physiologic effects (PE).
Class Type Browse
Central Nervous System Stimulant [EPC] EPC All 93 members
Central Nervous System Stimulation [PE] PE All 95 members

Regulatory status

Source: Drugs@FDANDC Directory
Application number
207388
Application type
ANDA · Abbreviated New Drug Application
Approval date
July 28, 2017
Sponsor
ALVOGEN
Products on application
7
Submissions recorded
3
Products approved under application 207388.
Product Trade name Form Strength Ingredient Status TE Flags
207388-001 DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE TABLET AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE Prescription AB
207388-002 DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE TABLET AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE Prescription AB
207388-003 DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE TABLET AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE Prescription AB
207388-004 DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE TABLET AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE Prescription AB
207388-005 DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE TABLET AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE Prescription AB
207388-006 DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE TABLET AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE Prescription AB
207388-007 DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE TABLET AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE Prescription AB

Therapeutic equivalence

Source: Orange Book
TE code
AB
Reference Listed Drug
No
Reference Standard
No

What this rating means: Therapeutically equivalent — bioequivalence demonstrated by in vivo or in vitro testing

Codes beginning with “A” indicate products the FDA considers therapeutically equivalent. Codes beginning with “B” indicate bioequivalence has not been established. See methodology.

Approval history

Source: Drugs@FDA
Most recent submissions on application 207388.
Type No. Action Status Date Review
Supplement 4 Labeling Approved October 20, 2023 Standard
Supplement 3 Labeling Approved February 25, 2022 Standard
Original application 1 Approved July 28, 2017 Standard

Adverse event reports

Source: openFDA FAERS
45,505
FAERS reports mentioning this drug
as of 2026-09-25T03:42:24+00:00
A report count is not a risk measure. FAERS accepts voluntary and mandatory reports without establishing causation, and reporting is influenced by how widely a drug is used, how long it has been marketed, and media attention. FDA states that reports “do not prove that the drug caused the event”. Compare rates, not totals.

Attributed to this product's most-reported active ingredient: DEXTROAMPHETAMINE SULFATE. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.

Packaging and NDCs

Source: NDC Directory
Every National Drug Code package associated with this medication. The NDC is the identifier used for dispensing, billing and pharmacovigilance in the United States.
Package NDC Product NDC Labeler Description Marketing start
47781-174-01 47781-174 Alvogen Inc. 100 TABLET in 1 BOTTLE (47781-174-01) July 28, 2017
47781-176-01 47781-176 Alvogen Inc. 100 TABLET in 1 BOTTLE (47781-176-01) July 28, 2017
47781-178-01 47781-178 Alvogen Inc. 100 TABLET in 1 BOTTLE (47781-178-01) July 28, 2017
47781-179-01 47781-179 Alvogen Inc. 100 TABLET in 1 BOTTLE (47781-179-01) July 28, 2017
47781-180-01 47781-180 Alvogen Inc. 100 TABLET in 1 BOTTLE (47781-180-01) July 28, 2017
47781-174 47781-174 Alvogen Inc. — July 28, 2017
47781-176 47781-176 Alvogen Inc. — July 28, 2017
47781-178 47781-178 Alvogen Inc. — July 28, 2017
47781-179 47781-179 Alvogen Inc. — July 28, 2017
47781-180 47781-180 Alvogen Inc. — July 28, 2017

Sources for this page

Every dataset that contributed a fact to this page.
Dataset Agency Used for
NDC Directory FDA Identity, ingredients, strengths, forms, routes, labelers, packages
Drugs@FDA FDA Application, sponsor, submissions, review documents, marketing status
Orange Book FDA Therapeutic equivalence codes, reference drug flags, patents, exclusivity
FAERS FDA Adverse event report counts

Generated September 25, 2026 · 10 sections on this page.