# PYRIDOSTIGMINE BROMIDE — FDA application ANDA040512

Informational only - not investment advice.

Application ANDA040512 · type ANDA · FDA status: approved · original approval 2003-10-08

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 | PYRIDOSTIGMINE BROMIDE | PYRIDOSTIGMINE BROMIDE | TABLET | ORAL | 60MG | Prescription | AB | No |
| 002 | PYRIDOSTIGMINE BROMIDE | PYRIDOSTIGMINE BROMIDE | TABLET | ORAL | 30MG | Discontinued | not listed | 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

- PYRIDOSTIGMINE BROMIDE · UNII KVI301NA53 · [lmmol compound VNYBTNPBYXSMOO-UHFFFAOYSA-M](https://lmmol.com/compound/VNYBTNPBYXSMOO-UHFFFAOYSA-M)

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:ANDA040512. FDA data retrieved 2026-08-07.

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