MORPHINE SULFATE | N019516 | KNOA PHARMA LLC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Aurolife Pharma LLC. FDA-2017-P-6307 · 4 docket documents Aurolife Pharma LLC submitted this citizen petition requesting that the FDA designate Morphine Sulfate Extended Release Tablets, 100 mg from Rhodes Pharmaceuticals LP (ANDA# A074769) as a reference standard for ANDA bioequivalence studies, because the original reference listed drug MS CONTIN (NDA# 0 | 505(q) | 2017-10-30 | Denied | Aurolife Pharma LLC. |
Citizen Petition From Purdue Pharma LP (Kleinfeld, Kaplan and Becker, LLP) FDA-2014-P-0205 · 4 docket documents Purdue Pharma LP filed this citizen petition requesting that the FDA exercise its authority under Section 505(o) of the Federal Food, Drug and Cosmetic Act to impose safety labeling changes on immediate-release opioid analgesics parallel to those mandated for extended-release and long-acting opioid | Other | 2014-02-25 | Partially Denied | Purdue Pharma LP (Kleinfeld, Kaplan and Becker, LLP) |
Lannett Company, Inc. and Cody Laboratories, Inc. (Alston & Bird LLP) - Citiz... FDA-2012-P-0053 · 5 docket documents Lannett Company Inc. and Cody Laboratories, Inc., through counsel at Alston & Bird, filed this citizen petition on January 12, 2012, under sections 201 and 505 of the Federal Food, Drug, and Cosmetic Act requesting that FDA affirm the grandfather status of morphine sulfate, including Lannett's Morph | Other | 2012-02-16 | Denied | — |
Actavis Elizabeth, LLC (Alston & Bird LLP) - Citizen Petition FDA-2010-P-0082 · 23 docket documents Actavis Elizabeth LLC filed this citizen petition under Section 505 of the Federal Food, Drug, and Cosmetic Act requesting that the FDA establish specific bioequivalence standards for Abbreviated New Drug Applications seeking approval of extended-release morphine sulfate products that cite KADIAN as | 505(q) | 2010-02-22 | Partially Denied | — |
Merchant & Gould P.C. - Citizen Petition FDA-2009-P-0388 · 6 docket documents Merchant & Gould P.C., on behalf of a client, filed this petition pursuant to Section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA determine that Morphine Sulfate Concentrate Oral Solution 20mg/mL is suitable for submission in an ANDA, with the Reference Listed Dr | Other | 2009-08-18 | Withdrawn | — |
Rakcczy Molino Mazzochi SIWIK LLP - Citizen Petition FDA-2008-P-0401 · 3 docket documents Rakoczy Molino Mazzocchi SIWIK LLP filed this suitability petition on July 10, 2008, under Section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA declare that an ANDA may be submitted for Morphine Sulfate Tablets in 5 mg, 10 mg, and 20 mg strengths, referencing Roxa | Other | 2008-07-16 | Withdrawn | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$8.90
per ea
Lowest NADAC/Unit
$4.68
per ea
Brand NDCs
2
Generic NDCs
0
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 42858063101MS CONTIN ER 30 MG TABLET | $8.90 | EA | Brand | $0.4336 | 2026-06-17 |
| 42858051501MS CONTIN ER 15 MG TABLET | $4.68 | EA | Brand | $0.3270 | 2025-07-01 |
Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.
No patent or exclusivity listings for this strength.