# VALSARTAN AND HYDROCHLOROTHIAZIDE — FDA application ANDA204382

Informational only - not investment advice.

Application ANDA204382 · type ANDA · FDA status: approved · original approval 2023-08-11

Listed sponsor: AMNEAL PHARMS · [AMRX company profile](/company/AMRX/) · 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 | VALSARTAN AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; VALSARTAN | TABLET | ORAL | 12.5MG;80MG | Prescription | AB | No |
| 002 | VALSARTAN AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; VALSARTAN | TABLET | ORAL | 12.5MG;160MG | Prescription | AB | No |
| 003 | VALSARTAN AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; VALSARTAN | TABLET | ORAL | 25MG;160MG | Prescription | AB | No |
| 004 | VALSARTAN AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; VALSARTAN | TABLET | ORAL | 12.5MG;320MG | Prescription | AB | No |
| 005 | VALSARTAN AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; VALSARTAN | TABLET | ORAL | 25MG;320MG | Prescription | AB | 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

- HYDROCHLOROTHIAZIDE · UNII 0J48LPH2TH · [lmmol compound JZUFKLXOESDKRF-UHFFFAOYSA-N](https://lmmol.com/compound/JZUFKLXOESDKRF-UHFFFAOYSA-N)
- VALSARTAN · UNII 80M03YXJ7I · [lmmol compound ACWBQPMHZXGDFX-QFIPXVFZSA-N](https://lmmol.com/compound/ACWBQPMHZXGDFX-QFIPXVFZSA-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/AMRX/)
- [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:ANDA204382. FDA data retrieved 2026-08-07.

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