Details for New Drug Application (NDA): 021992
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NDA 021992 describes PRISTIQ, which is a drug marketed by Pf Prism Cv and is included in one NDA. It is available from two suppliers. There is one patent protecting this drug and two Paragraph IV challenges. Additional details are available on the PRISTIQ profile page.
The generic ingredient in PRISTIQ is desvenlafaxine succinate. There are sixteen drug master file entries for this compound. Twenty-two suppliers are listed for this compound. Additional details are available on the desvenlafaxine succinate profile page.
The generic ingredient in PRISTIQ is desvenlafaxine succinate. There are sixteen drug master file entries for this compound. Twenty-two suppliers are listed for this compound. Additional details are available on the desvenlafaxine succinate profile page.
Summary for 021992
| Tradename: | PRISTIQ |
| Applicant: | Pf Prism Cv |
| Ingredient: | desvenlafaxine succinate |
| Patents: | 1 |
| Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 021992
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PRISTIQ | desvenlafaxine succinate | TABLET, EXTENDED RELEASE;ORAL | 021992 | NDA | Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. | 0008-1210 | 0008-1210-30 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0008-1210-30) |
| PRISTIQ | desvenlafaxine succinate | TABLET, EXTENDED RELEASE;ORAL | 021992 | NDA | Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. | 0008-1211 | 0008-1211-01 | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0008-1211-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | EQ 50MG BASE | ||||
| Approval Date: | Feb 29, 2008 | TE: | AB | RLD: | Yes | ||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Jul 5, 2027 | Product Flag? | Substance Flag? | Y | Delist Request? | ||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | EQ 100MG BASE | ||||
| Approval Date: | Feb 29, 2008 | TE: | AB | RLD: | Yes | ||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Jul 5, 2027 | Product Flag? | Substance Flag? | Y | Delist Request? | ||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | EQ 25MG BASE | ||||
| Approval Date: | Aug 20, 2014 | TE: | AB | RLD: | Yes | ||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Jul 5, 2027 | Product Flag? | Substance Flag? | Y | Delist Request? | ||
Expired US Patents for NDA 021992
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Pf Prism Cv | PRISTIQ | desvenlafaxine succinate | TABLET, EXTENDED RELEASE;ORAL | 021992-001 | Feb 29, 2008 | ⤷ Try a Trial | ⤷ Try a Trial |
| Pf Prism Cv | PRISTIQ | desvenlafaxine succinate | TABLET, EXTENDED RELEASE;ORAL | 021992-002 | Feb 29, 2008 | ⤷ Try a Trial | ⤷ Try a Trial |
| Pf Prism Cv | PRISTIQ | desvenlafaxine succinate | TABLET, EXTENDED RELEASE;ORAL | 021992-002 | Feb 29, 2008 | ⤷ Try a Trial | ⤷ Try a Trial |
| Pf Prism Cv | PRISTIQ | desvenlafaxine succinate | TABLET, EXTENDED RELEASE;ORAL | 021992-003 | Aug 20, 2014 | ⤷ Try a Trial | ⤷ Try a Trial |
| Pf Prism Cv | PRISTIQ | desvenlafaxine succinate | TABLET, EXTENDED RELEASE;ORAL | 021992-001 | Feb 29, 2008 | ⤷ Try a Trial | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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