# INNOPRAN XL — FDA application NDA021438

Informational only - not investment advice.

Application NDA021438 · type NDA · FDA status: approved · original approval 2003-03-12

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 | INNOPRAN XL | PROPRANOLOL HYDROCHLORIDE | CAPSULE, EXTENDED RELEASE | ORAL | 80MG | Prescription | BX | Yes |
| 002 | INNOPRAN XL | PROPRANOLOL HYDROCHLORIDE | CAPSULE, EXTENDED RELEASE | ORAL | 120MG | Prescription | BX | Yes |

## 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

- PROPRANOLOL HYDROCHLORIDE · UNII F8A3652H1V · [lmmol compound ZMRUPTIKESYGQW-UHFFFAOYSA-N](https://lmmol.com/compound/ZMRUPTIKESYGQW-UHFFFAOYSA-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:NDA021438. FDA data retrieved 2026-08-07.

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