Details for New Drug Application (NDA): 209128
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NDA 209128 describes DSUVIA, which is a drug marketed by Vertical Pharms and is included in one NDA. It is available from one supplier. There are twenty-one patents protecting this drug. Additional details are available on the DSUVIA profile page.
The generic ingredient in DSUVIA is sufentanil citrate. There are nine drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the sufentanil citrate profile page.
The generic ingredient in DSUVIA is sufentanil citrate. There are nine drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the sufentanil citrate profile page.
Summary for 209128
| Tradename: | DSUVIA |
| Applicant: | Vertical Pharms |
| Ingredient: | sufentanil citrate |
| Patents: | 21 |
Pharmacology for NDA: 209128
| Mechanism of Action | Full Opioid Agonists |
Medical Subject Heading (MeSH) Categories for 209128
Suppliers and Packaging for NDA: 209128
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DSUVIA | sufentanil citrate | TABLET;SUBLINGUAL | 209128 | NDA | AcelRx Pharmaceuticals, Inc. | 61621-430 | 61621-430-01 | 1 TABLET in 1 POUCH (61621-430-01) |
| DSUVIA | sufentanil citrate | TABLET;SUBLINGUAL | 209128 | NDA | AcelRx Pharmaceuticals, Inc. | 61621-430 | 61621-430-11 | 10 TABLET in 1 CARTON (61621-430-11) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;SUBLINGUAL | Strength | EQ 0.03MG BASE | ||||
| Approval Date: | Nov 2, 2018 | TE: | RLD: | Yes | |||||
| Patent: | 10,245,228 | Patent Expiration: | Jan 5, 2027 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | TREATMENT OF ACUTE PAIN | ||||||||
| Patent: | 10,342,762 | Patent Expiration: | Jan 5, 2027 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | 10,507,180 | Patent Expiration: | Jan 5, 2027 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | TREATMENT OF ACUTE PAIN | ||||||||
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