CARISOPRODOL | N011792 | MYLAN SPECIALTY LP
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition A from Biopharmaceutics, Inc. FDA-1988-P-0040 Biopharmaceutics, Inc. filed this citizen petition under 21 U.S.C. Section 505(j)(2)(A) and (C) requesting that the FDA find the combination drug Carisoprodol 200mg and Acetaminophen 325mg suitable for abbreviated new drug application approval, arguing that Acetaminophen can substitute for Aspirin i | Other | 2017-06-28 | Withdrawn | — |
Citizen Petition B from Biopharmaceutics, Inc. FDA-1988-P-0040 Biopharmaceutics, Inc. filed this citizen petition on June 17, 1988, under 21 U.S.C. Section 505(j)(2)(A) and (C), requesting that the FDA find a combination drug product containing Carisoprodol 200 mg and Acetaminophen 325 mg suitable for approval as an Abbreviated New Drug Application. The petitio | 505(q) | 2017-06-28 | Withdrawn | — |
Lachman Consultant Services, Inc. - Citizen Petition FDA-2013-P-0945 Lachman Consultant Services, Inc. filed this citizen petition on behalf of a client pursuant to Section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act, requesting that the FDA declare Carisoprodol Tablets, 300 mg, suitable for submission in an ANDA, with Soma Tablets, 250 mg (NDA 011792, he | Other | 2013-08-26 | Granted | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$11.30
per ea
Lowest NADAC/Unit
$0.5313
per ea
Brand NDCs
1
Generic NDCs
1
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 00037200101SOMA 350 MG TABLET | $11.30 | EA | Brand | $0.0728 | 2026-10-21 |
| 51525590101CARISOPRODOL 250 MG TABLET | $0.5313 | EA | Generic | — | 2026-10-21 |
Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.
No patent or exclusivity listings for this strength.