Details for New Drug Application (NDA): 220173
NDA 220173 describes DIMETHYL SULFOXIDE, which is a drug marketed by Mylan Institutional and Pharmobedient and is included in two NDAs. It is available from one supplier. Additional details are available on the DIMETHYL SULFOXIDE profile page.
The generic ingredient in DIMETHYL SULFOXIDE is dimethyl sulfoxide. There is one drug master file entry for this compound. Two suppliers are listed for this compound. Additional details are available on the dimethyl sulfoxide profile page.
The generic ingredient in DIMETHYL SULFOXIDE is dimethyl sulfoxide. There is one drug master file entry for this compound. Two suppliers are listed for this compound. Additional details are available on the dimethyl sulfoxide profile page.
Summary for 220173
| Tradename: | DIMETHYL SULFOXIDE |
| Applicant: | Pharmobedient |
| Ingredient: | dimethyl sulfoxide |
| Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 220173
Suppliers and Packaging for NDA: 220173
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DIMETHYL SULFOXIDE | dimethyl sulfoxide | SOLUTION;INTRAVESICAL | 220173 | ANDA | Renova Pharmaceuticals LLC | 84897-052 | 84897-052-01 | 1 VIAL, GLASS in 1 CARTON (84897-052-01) / 50 mL in 1 VIAL, GLASS |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVESICAL | Strength | 50% | ||||
| Approval Date: | Jul 7, 2026 | TE: | AT | RLD: | No | ||||
| Regulatory Exclusivity Expiration: | Mar 10, 2027 | ||||||||
| Regulatory Exclusivity Use: | COMPETITIVE GENERIC THERAPY | ||||||||
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