Details for New Drug Application (NDA): 214044
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NDA 214044 describes QDOLO, which is a drug marketed by Athena and is included in one NDA. It is available from three suppliers. There are two patents protecting this drug. Additional details are available on the QDOLO profile page.
The generic ingredient in QDOLO is tramadol hydrochloride. There are thirty-six drug master file entries for this compound. Forty-eight suppliers are listed for this compound. Additional details are available on the tramadol hydrochloride profile page.
The generic ingredient in QDOLO is tramadol hydrochloride. There are thirty-six drug master file entries for this compound. Forty-eight suppliers are listed for this compound. Additional details are available on the tramadol hydrochloride profile page.
Summary for 214044
| Tradename: | QDOLO |
| Applicant: | Athena |
| Ingredient: | tramadol hydrochloride |
| Patents: | 2 |
Pharmacology for NDA: 214044
| Mechanism of Action | Full Opioid Agonists |
Medical Subject Heading (MeSH) Categories for 214044
Suppliers and Packaging for NDA: 214044
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| QDOLO | tramadol hydrochloride | SOLUTION;ORAL | 214044 | NDA AUTHORIZED GENERIC | TruPharma, LLC | 52817-615 | 52817-615-16 | 473 mL in 1 BOTTLE (52817-615-16) |
| QDOLO | tramadol hydrochloride | SOLUTION;ORAL | 214044 | NDA AUTHORIZED GENERIC | Palmetto Pharmaceuticals, Inc. | 68134-402 | 68134-402-40 | 4 TRAY in 1 CASE (68134-402-40) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (68134-402-05) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;ORAL | Strength | 5MG/ML | ||||
| Approval Date: | Sep 1, 2020 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Sign Up | Patent Expiration: | Sep 1, 2040 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE AN OPIOID ANALGESIC AND FOR WHICH ALTERNATIVE TREATMENTS ARE INADEQUATE | ||||||||
| Patent: | ⤷ Sign Up | Patent Expiration: | Sep 1, 2040 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE AN OPIOID ANALGESIC AND FOR WHICH ALTERNATIVE TREATMENTS ARE INADEQUATE | ||||||||
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