ANDA 207001, held by Hq Spclt Pharma. Linezolid.
As of Nov 15, 2026, ANDA 207001 (Linezolid), held by Hq Spclt Pharma, was first approved by FDA on Jul 7, 2017, with 6 approved supplements and 0 published complete response letters.
Linezolid Injection is an oxazolidinone-class antibacterial indicated in adults and children for the treatment of the following infections caused by susceptible Gram-positive bacteria: Nosocomial pneumonia; Community-acquired pneumonia; Complicated skin and skin structure infections, including diabetic foot infections, without concomitant osteomyelitis; Uncomplicated skin and skin structure infections; Vancomycin-resistant Enterococcus faecium infections. Limitations of Use:
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 7, 2017 | Original application | Approved | None posted |
| May 22, 2025 | Supplement 10Labeling · Standard review | Approved | None posted |
| Jan 10, 2024 | Supplement 2Labeling · Standard review | Approved | None posted |
| Jan 10, 2024 | Supplement 4Labeling · Standard review | Approved | None posted |
| Jan 10, 2024 | Supplement 5Labeling · Standard review | Approved | None posted |
| Jan 10, 2024 | Supplement 6Labeling · Standard review | Approved | None posted |
| Jan 10, 2024 | Supplement 8Labeling · Standard review | Approved | None posted |
| Jul 7, 2017 | Original application | Approved | None posted |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
