# UNASYN — FDA application NDA050608

Informational only - not investment advice.

Application NDA050608 · type NDA · FDA status: approved · original approval 1986-12-31

Listed sponsor: PFIZER · [PFE company profile](/company/PFE/) · 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 | UNASYN | AMPICILLIN SODIUM; SULBACTAM SODIUM | INJECTABLE | INJECTION | EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL | Prescription | AP | Yes |
| 002 | UNASYN | AMPICILLIN SODIUM; SULBACTAM SODIUM | INJECTABLE | INJECTION | EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL | Prescription | AP | Yes |
| 003 | UNASYN | AMPICILLIN SODIUM; SULBACTAM SODIUM | INJECTABLE | INJECTION | EQ 500MG BASE/VIAL;EQ 250MG BASE/VIAL | Discontinued | not listed | No |
| 005 | UNASYN | AMPICILLIN SODIUM; SULBACTAM SODIUM | INJECTABLE | INJECTION | EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL | Prescription | AP | 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

- AMPICILLIN SODIUM · UNII JFN36L5S8K · [lmmol compound KLOHDWPABZXLGI-YWUHCJSESA-M](https://lmmol.com/compound/KLOHDWPABZXLGI-YWUHCJSESA-M)
- SULBACTAM SODIUM · UNII DKQ4T82YE6 · [lmmol compound NKZMPZCWBSWAOX-IBTYICNHSA-M](https://lmmol.com/compound/NKZMPZCWBSWAOX-IBTYICNHSA-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/PFE/)
- [FDA-approved application index](/drug/)
- [Large-cap biopharma](/compare/pharma/)

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:NDA050608. FDA data retrieved 2026-08-07.

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