# DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE — FDA application ANDA205401

Informational only - not investment advice.

Application ANDA205401 · type ANDA · FDA status: approved · original approval 2019-01-22

Listed sponsor: ANI PHARMS · [ANIP company profile](/company/ANIP/) · exact_unique

Sponsor as listed in Drugs@FDA at retrieval (2026-08-07); FDA sponsor listings can lag ownership transfers.

## FDA application facts

| Product | FDA-listed trade name | Active ingredient | Dosage form | Route | Strength | Marketing status | TE code | RLD |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 001 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE | AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE | CAPSULE, EXTENDED RELEASE | ORAL | 1.25MG;1.25MG;1.25MG;1.25MG | Prescription | AB1 | No |
| 002 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE | AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE | CAPSULE, EXTENDED RELEASE | ORAL | 2.5MG;2.5MG;2.5MG;2.5MG | Prescription | AB1 | No |
| 003 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE | AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE | CAPSULE, EXTENDED RELEASE | ORAL | 3.75MG;3.75MG;3.75MG;3.75MG | Prescription | AB1 | No |
| 004 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE | AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE | CAPSULE, EXTENDED RELEASE | ORAL | 5MG;5MG;5MG;5MG | Prescription | AB1 | No |
| 005 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE | AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE | CAPSULE, EXTENDED RELEASE | ORAL | 6.25MG;6.25MG;6.25MG;6.25MG | Prescription | AB1 | No |
| 006 | DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE | AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE | CAPSULE, EXTENDED RELEASE | ORAL | 7.5MG;7.5MG;7.5MG;7.5MG | Prescription | AB1 | No |

## Orange Book patent and exclusivity listings

No Orange Book patent or exclusivity listings joined to this application.

Patent and exclusivity dates are regulatory listings from the FDA Orange Book; no relationship to revenue or future sales is stated or implied.

## Compound cross-links

- AMPHETAMINE DL-ASPARTATE MONOHYDRATE · UNII O1ZPV620O4 · no lmmol compound match
- AMPHETAMINE SULFATE · UNII 6DPV8NK46S · no lmmol compound match
- DEXTROAMPHETAMINE SACCHARATE · UNII G83415V073 · no lmmol compound match
- DEXTROAMPHETAMINE SULFATE · UNII JJ768O327N · [lmmol compound PYHRZPFZZDCOPH-QXGOIDDHSA-N](https://lmmol.com/compound/PYHRZPFZZDCOPH-QXGOIDDHSA-N)

Ingredient–compound links use FDA openFDA/GSRS identifiers and an exact lmmol InChIKey join. Ingredient names cannot create a link.

## Related pages

- [Sponsor company](/company/ANIP/)
- [FDA-approved application index](/drug/)

Sources: https://www.fda.gov/drugs/drug-approvals-and-databases/drugsfda-data-files · https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files · https://api.fda.gov/drug/drugsfda.json?search=application_number:ANDA205401. FDA data retrieved 2026-08-07.

Regulatory listing data as published by FDA; not medical or investment advice.