Home Applications 021992 Application 021992
Type NDA
Sponsor PF PRISM CV Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 PRISTIQ DESVENLAFAXINE SUCCINATE TABLET, EXTENDED RELEASE;ORAL EQ 50MG BASE Yes Yes 002 PRISTIQ DESVENLAFAXINE SUCCINATE TABLET, EXTENDED RELEASE;ORAL EQ 100MG BASE Yes Yes 003 PRISTIQ DESVENLAFAXINE SUCCINATE TABLET, EXTENDED RELEASE;ORAL EQ 25MG BASE Yes No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N021992-001 PRISTIQ DESVENLAFAXINE SUCCINATE EQ 50MG BASE TABLET, EXTENDED RELEASE / ORAL AB RLD 2008-02-29 N021992-002 PRISTIQ DESVENLAFAXINE SUCCINATE EQ 100MG BASE TABLET, EXTENDED RELEASE / ORAL AB RLD, RS 2008-02-29 N021992-003 PRISTIQ DESVENLAFAXINE SUCCINATE EQ 25MG BASE TABLET, EXTENDED RELEASE / ORAL AB RLD 2014-08-20
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 matching rows.
Orange Book patents# Current patent rows page 1 of 1 · 3 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N021992-001 8269040 2027-07-05 Drug substance N021992-002 8269040 2027-07-05 Drug substance N021992-003 8269040 2027-07-05 Drug substance 2015-02-02
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 4 of 4 · 132 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2022-10-28 04:53 UTC 2022-10 N021992-001 PRISTIQ EQ 50MG BASE TABLET, EXTENDED RELEASE / ORAL AB RLD 2008-02-29 f41ea6bd6efb…2022-10-28 04:53 UTC 2022-10 N021992-002 PRISTIQ EQ 100MG BASE TABLET, EXTENDED RELEASE / ORAL AB RLD, RS 2008-02-29 f41ea6bd6efb…2022-10-28 04:53 UTC 2022-10 N021992-003 PRISTIQ EQ 25MG BASE TABLET, EXTENDED RELEASE / ORAL AB RLD 2014-08-20 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N021992-001 PRISTIQ EQ 50MG BASE TABLET, EXTENDED RELEASE / ORAL AB RLD 2008-02-29 e64feba35796…2022-09-29 23:25 UTC 2022-09 N021992-002 PRISTIQ EQ 100MG BASE TABLET, EXTENDED RELEASE / ORAL AB RLD, RS 2008-02-29 e64feba35796…2022-09-29 23:25 UTC 2022-09 N021992-003 PRISTIQ EQ 25MG BASE TABLET, EXTENDED RELEASE / ORAL AB RLD 2014-08-20 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N021992-001 PRISTIQ EQ 50MG BASE TABLET, EXTENDED RELEASE / ORAL AB RLD 2008-02-29 cb3db0bc1861…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N021992-002 PRISTIQ EQ 100MG BASE TABLET, EXTENDED RELEASE / ORAL AB RLD, RS 2008-02-29 cb3db0bc1861…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N021992-003 PRISTIQ EQ 25MG BASE TABLET, EXTENDED RELEASE / ORAL AB RLD 2014-08-20 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N021992-001 PRISTIQ EQ 50MG BASE TABLET, EXTENDED RELEASE / ORAL AB RLD 2008-02-29 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N021992-002 PRISTIQ EQ 100MG BASE TABLET, EXTENDED RELEASE / ORAL AB RLD, RS 2008-02-29 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N021992-003 PRISTIQ EQ 25MG BASE TABLET, EXTENDED RELEASE / ORAL AB RLD 2014-08-20 a50c72e98297…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 132 observed states.
Observed Orange Book patent history# Patent history page 1 of 6 · 240 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-10-15 13:18:30 2026-09 N021992-001 8269040 2027-07-05 Drug substance c2088c7a36db…2026-10-15 13:18:30 2026-09 N021992-002 8269040 2027-07-05 Drug substance c2088c7a36db…2026-10-15 13:18:30 2026-09 N021992-003 8269040 2027-07-05 Drug substance 2015-02-02 c2088c7a36db…2026-09-14 22:38:34 2026-08 N021992-001 8269040 2027-07-05 Drug substance 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021992-002 8269040 2027-07-05 Drug substance 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021992-003 8269040 2027-07-05 Drug substance 2015-02-02 84e616aacf4f…2026-08-18 06:07:40 2026-07 N021992-001 8269040 2027-07-05 Drug substance caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021992-002 8269040 2027-07-05 Drug substance caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021992-003 8269040 2027-07-05 Drug substance 2015-02-02 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N021992-001 8269040 2027-07-05 Drug substance 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021992-002 8269040 2027-07-05 Drug substance 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021992-003 8269040 2027-07-05 Drug substance 2015-02-02 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021992-001 8269040 2027-07-05 Drug substance 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021992-002 8269040 2027-07-05 Drug substance 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021992-003 8269040 2027-07-05 Drug substance 2015-02-02 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021992-001 8269040 2027-07-05 Drug substance 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021992-002 8269040 2027-07-05 Drug substance 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021992-003 8269040 2027-07-05 Drug substance 2015-02-02 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021992-001 8269040 2027-07-05 Drug substance fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021992-002 8269040 2027-07-05 Drug substance fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021992-003 8269040 2027-07-05 Drug substance 2015-02-02 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021992-001 8269040 2027-07-05 Drug substance b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021992-002 8269040 2027-07-05 Drug substance b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021992-003 8269040 2027-07-05 Drug substance 2015-02-02 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021992-001 8269040 2027-07-05 Drug substance 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021992-002 8269040 2027-07-05 Drug substance 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021992-003 8269040 2027-07-05 Drug substance 2015-02-02 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021992-001 8269040 2027-07-05 Drug substance 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021992-002 8269040 2027-07-05 Drug substance 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021992-003 8269040 2027-07-05 Drug substance 2015-02-02 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021992-001 8269040 2027-07-05 Drug substance 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021992-002 8269040 2027-07-05 Drug substance 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021992-003 8269040 2027-07-05 Drug substance 2015-02-02 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021992-001 8269040 2027-07-05 Drug substance d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021992-002 8269040 2027-07-05 Drug substance d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021992-003 8269040 2027-07-05 Drug substance 2015-02-02 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021992-001 8269040 2027-07-05 Drug substance d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021992-002 8269040 2027-07-05 Drug substance d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021992-003 8269040 2027-07-05 Drug substance 2015-02-02 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021992-001 8269040 2027-07-05 Drug substance 79d66fd596c7…
Observed Orange Book exclusivity history# openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 43 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0008-1210 Pristiq desvenlafaxine succinate Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. NDA Current 0008-1210 Pristiq desvenlafaxine succinate Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. NDA Current 0008-1210 Pristiq desvenlafaxine succinate Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. NDA Current 0008-1210 Pristiq desvenlafaxine succinate Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. NDA Current 0008-1210 Pristiq desvenlafaxine succinate Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. NDA Current 0008-1211 Pristiq desvenlafaxine succinate Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. NDA Current 0008-1211 Pristiq desvenlafaxine succinate Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. NDA Current 0008-1211 Pristiq desvenlafaxine succinate Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. NDA Current 0008-1211 Pristiq desvenlafaxine succinate Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. NDA Current 0008-1211 Pristiq desvenlafaxine succinate Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. NDA Current 0008-1222 Pristiq desvenlafaxine succinate Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. NDA Current 0008-1222 Pristiq desvenlafaxine succinate Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. NDA Current 0008-1222 Pristiq desvenlafaxine succinate Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. NDA Current 0008-1222 Pristiq desvenlafaxine succinate Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. NDA Current 0008-1222 Pristiq desvenlafaxine succinate Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. NDA Current 35356-491 Pristiq desvenlafaxine succinate Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC NDA Current 43063-262 Pristiq desvenlafaxine succinate PD-Rx Pharmaceuticals, Inc. NDA Current 43063-262 Pristiq desvenlafaxine succinate PD-Rx Pharmaceuticals, Inc. NDA Current 43063-262 Pristiq desvenlafaxine succinate PD-Rx Pharmaceuticals, Inc. NDA Current 43063-262 Pristiq desvenlafaxine succinate PD-Rx Pharmaceuticals, Inc. NDA Current 43063-262 Pristiq desvenlafaxine succinate PD-Rx Pharmaceuticals, Inc. NDA Current 43063-262 Pristiq desvenlafaxine succinate PD-Rx Pharmaceuticals, Inc. NDA Current 50090-4069 Desvenlafaxine Succinate desvenlafaxine succinate A-S Medication Solutions NDA AUTHORIZED GENERIC Current 55154-4230 Pristiq desvenlafaxine succinate Cardinal Health NDA Current 55154-4235 Pristiq desvenlafaxine succinate Cardinal Health NDA Current 59762-1210 Desvenlafaxine Succinate desvenlafaxine succinate Greenstone LLC NDA AUTHORIZED GENERIC Current 59762-1210 Desvenlafaxine Succinate desvenlafaxine succinate Greenstone LLC NDA AUTHORIZED GENERIC Current 59762-1210 Desvenlafaxine Succinate desvenlafaxine succinate Greenstone LLC NDA AUTHORIZED GENERIC Current 59762-1210 Desvenlafaxine Succinate desvenlafaxine succinate Greenstone LLC NDA AUTHORIZED GENERIC Current 59762-1210 Desvenlafaxine Succinate desvenlafaxine succinate Greenstone LLC NDA AUTHORIZED GENERIC Current 59762-1210 Desvenlafaxine Succinate desvenlafaxine succinate Greenstone LLC NDA AUTHORIZED GENERIC Current 59762-1211 Desvenlafaxine Succinate desvenlafaxine succinate Greenstone LLC NDA AUTHORIZED GENERIC Current 59762-1211 Desvenlafaxine Succinate desvenlafaxine succinate Greenstone LLC NDA AUTHORIZED GENERIC Current 59762-1211 Desvenlafaxine Succinate desvenlafaxine succinate Greenstone LLC NDA AUTHORIZED GENERIC Current 59762-1211 Desvenlafaxine Succinate desvenlafaxine succinate Greenstone LLC NDA AUTHORIZED GENERIC Current 59762-1211 Desvenlafaxine Succinate desvenlafaxine succinate Greenstone LLC NDA AUTHORIZED GENERIC Current 59762-1211 Desvenlafaxine Succinate desvenlafaxine succinate Greenstone LLC NDA AUTHORIZED GENERIC Current 59762-1222 Desvenlafaxine Succinate desvenlafaxine succinate Greenstone LLC NDA AUTHORIZED GENERIC Current 59762-1222 Desvenlafaxine Succinate desvenlafaxine succinate Greenstone LLC NDA AUTHORIZED GENERIC Current 59762-1222 Desvenlafaxine Succinate desvenlafaxine succinate Greenstone LLC NDA AUTHORIZED GENERIC Current 59762-1222 Desvenlafaxine Succinate desvenlafaxine succinate Greenstone LLC NDA AUTHORIZED GENERIC Current 59762-1222 Desvenlafaxine Succinate desvenlafaxine succinate Greenstone LLC NDA AUTHORIZED GENERIC Current 59762-1222 Desvenlafaxine Succinate desvenlafaxine succinate Greenstone LLC NDA AUTHORIZED GENERIC Current