ANDA 206573, held by Pharm Assoc. Morphine Sulfate.
As of Nov 15, 2026, ANDA 206573 (Morphine Sulfate), held by Pharm Assoc, was first approved by FDA on Nov 14, 2016, with 8 approved supplements and 0 published complete response letters.
Morphine Sulfate Oral Solution 2 mg/mL is indicated for the management of: adults with acute and chronic pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Morphine Sulfate Oral Solution 20 mg/mL is indicated for the relief of acute and chronic pain in opioid-tolerant adult patients. Limitations of Use Because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosage or duration, reserve Morphine Sulfate Oral Solution for use in patients for whom alternative treatment options (e.g.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 14, 2016 | Original application | Approved |
| Morphine Sulfate100MG/5ML · solution;oral | Morphine Sulfate | Rx |
| Morphine Sulfate10MG/5ML · solution;oral | Morphine Sulfate | Rx |
| Jun 18, 2026 | Supplement 19REMS | Approved | None posted |
| Oct 31, 2024 | Supplement 13REMS | Approved | None posted |
| May 8, 2023 | Supplement 10Labeling · Standard review | Approved | None posted |
| May 8, 2023 | Supplement 8Labeling · Standard review | Approved | None posted |
| May 8, 2023 | Supplement 6Labeling · Standard review | Approved | None posted |
| May 8, 2023 | Supplement 4Labeling · Standard review | Approved | None posted |
| May 8, 2023 | Supplement 2Labeling · Standard review | Approved | None posted |
| Sep 18, 2018 | Supplement 1REMS | Approved | None posted |
| Nov 14, 2016 | Original application | Approved |
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
