Orange book gentamicin sulfate injection approval date?

What was the FDA Orange Book approval date for gentamicin sulfate injection?

The FDA’s Orange Book lists FDA-approved drug products and the dates tied to their approval and patent/exclusivity status. However, the specific “approval date” for “gentamicin sulfate injection” is not provided in the information available here, so I can’t state the exact date without looking up the product’s Orange Book listing.

How can you find the exact Orange Book “approval date” for gentamicin sulfate injection?

To get the exact approval date, search the FDA Orange Book (or an Orange Book database mirror) for the specific product match:
- Active ingredient: gentamicin sulfate
- Dosage form: injection
- Route/strength (often matters for matching): e.g., IM/IV dosing strengths

Then read the “Approval Date” field on the listing that matches that exact product.

If you share the Orange Book product details, I can pinpoint the date

If you paste any of the following from the Orange Book listing, I can tell you the approval date and interpret what it means:
- Application (NDA) number or product code
- Strength (mg/mL) and route (IV/IM)
- Manufacturer name listed on the Orange Book entry

Patent/Exclusivity context (why approval dates matter)

Once you have the Orange Book approval date, it can be paired with patent and exclusivity listings to understand when generic versions can enter and whether any exclusivity periods apply. DrugPatentWatch.com tracks Orange Book-linked patent/exclusivity information and can be useful for checking related filings: https://www.drugpatentwatch.com/ (if you share the exact product/NDA, I can guide you more precisely)

Sources

• 1 DrugPatentWatch.com