Home Applications 019839 Application 019839
Type NDA
Sponsor PFIZER Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 ZOLOFT SERTRALINE HYDROCHLORIDE TABLET;ORAL EQ 50MG BASE Yes No 002 ZOLOFT SERTRALINE HYDROCHLORIDE TABLET;ORAL EQ 100MG BASE Yes Yes 003 ZOLOFT SERTRALINE HYDROCHLORIDE TABLET;ORAL EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** Yes No 004 ZOLOFT SERTRALINE HYDROCHLORIDE TABLET;ORAL EQ 200MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** Yes No 005 ZOLOFT SERTRALINE HYDROCHLORIDE TABLET;ORAL EQ 25MG BASE Yes No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 5 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N019839-001 ZOLOFT SERTRALINE HYDROCHLORIDE EQ 50MG BASE TABLET / ORAL AB RLD 1991-12-30 N019839-002 ZOLOFT SERTRALINE HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL AB RLD, RS 1991-12-30 N019839-003 ZOLOFT SERTRALINE HYDROCHLORIDE EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1991-12-30 N019839-004 ZOLOFT SERTRALINE HYDROCHLORIDE EQ 200MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1991-12-30 N019839-005 ZOLOFT SERTRALINE HYDROCHLORIDE EQ 25MG BASE TABLET / ORAL AB RLD 1996-03-06
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 matching rows.
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 1 of 6 · 210 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 2026-08-18 06:07:40 2026-07 N019839-001 ZOLOFT EQ 50MG BASE TABLET / ORAL AB RLD 1991-12-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N019839-002 ZOLOFT EQ 100MG BASE TABLET / ORAL AB RLD, RS 1991-12-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N019839-003 ZOLOFT EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1991-12-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N019839-004 ZOLOFT EQ 200MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1991-12-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N019839-005 ZOLOFT EQ 25MG BASE TABLET / ORAL AB RLD 1996-03-06 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N019839-001 ZOLOFT EQ 50MG BASE TABLET / ORAL AB RLD 1991-12-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N019839-002 ZOLOFT EQ 100MG BASE TABLET / ORAL AB RLD, RS 1991-12-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N019839-003 ZOLOFT EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1991-12-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N019839-004 ZOLOFT EQ 200MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1991-12-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N019839-005 ZOLOFT EQ 25MG BASE TABLET / ORAL AB RLD 1996-03-06 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019839-001 ZOLOFT EQ 50MG BASE TABLET / ORAL AB RLD 1991-12-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019839-002 ZOLOFT EQ 100MG BASE TABLET / ORAL AB RLD, RS 1991-12-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019839-003 ZOLOFT EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1991-12-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019839-004 ZOLOFT EQ 200MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1991-12-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019839-005 ZOLOFT EQ 25MG BASE TABLET / ORAL AB RLD 1996-03-06 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N019839-001 ZOLOFT EQ 50MG BASE TABLET / ORAL AB RLD 1991-12-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N019839-002 ZOLOFT EQ 100MG BASE TABLET / ORAL AB RLD, RS 1991-12-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N019839-003 ZOLOFT EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1991-12-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N019839-004 ZOLOFT EQ 200MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1991-12-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N019839-005 ZOLOFT EQ 25MG BASE TABLET / ORAL AB RLD 1996-03-06 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019839-001 ZOLOFT EQ 50MG BASE TABLET / ORAL AB RLD 1991-12-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019839-002 ZOLOFT EQ 100MG BASE TABLET / ORAL AB RLD, RS 1991-12-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019839-003 ZOLOFT EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1991-12-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019839-004 ZOLOFT EQ 200MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1991-12-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019839-005 ZOLOFT EQ 25MG BASE TABLET / ORAL AB RLD 1996-03-06 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019839-001 ZOLOFT EQ 50MG BASE TABLET / ORAL AB RLD 1991-12-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019839-002 ZOLOFT EQ 100MG BASE TABLET / ORAL AB RLD, RS 1991-12-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019839-003 ZOLOFT EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1991-12-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019839-004 ZOLOFT EQ 200MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1991-12-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019839-005 ZOLOFT EQ 25MG BASE TABLET / ORAL AB RLD 1996-03-06 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N019839-001 ZOLOFT EQ 50MG BASE TABLET / ORAL AB RLD 1991-12-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N019839-002 ZOLOFT EQ 100MG BASE TABLET / ORAL AB RLD, RS 1991-12-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N019839-003 ZOLOFT EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1991-12-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N019839-004 ZOLOFT EQ 200MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1991-12-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N019839-005 ZOLOFT EQ 25MG BASE TABLET / ORAL AB RLD 1996-03-06 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N019839-001 ZOLOFT EQ 50MG BASE TABLET / ORAL AB RLD 1991-12-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N019839-002 ZOLOFT EQ 100MG BASE TABLET / ORAL AB RLD, RS 1991-12-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N019839-003 ZOLOFT EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1991-12-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N019839-004 ZOLOFT EQ 200MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1991-12-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N019839-005 ZOLOFT EQ 25MG BASE TABLET / ORAL AB RLD 1996-03-06 2680178bc6a6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 126 observed states.
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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Zoloft SERTRALINE HYDROCHLORIDE Viatris Specialty LLC fda754f6-d0f3-4dce-a17a-927d64f912f7 2023-08-08 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 019839 application number: NDA019839
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 74 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0049-4900 Zoloft sertraline hydrochloride Roerig NDA Current 0049-4900 Zoloft sertraline hydrochloride Roerig NDA Current 0049-4900 Zoloft sertraline hydrochloride Roerig NDA Current 0049-4900 Zoloft sertraline hydrochloride Roerig NDA Current 0049-4900 Zoloft sertraline hydrochloride Roerig NDA Current 0049-4900 Zoloft sertraline hydrochloride Roerig NDA Current 0049-4900 Zoloft sertraline hydrochloride Roerig NDA Current 0049-4900 Zoloft sertraline hydrochloride Roerig NDA Current 0049-4900 Zoloft sertraline hydrochloride Roerig NDA Current 0049-4900 Zoloft sertraline hydrochloride Roerig NDA Current 0049-4910 Zoloft sertraline hydrochloride Roerig NDA Current 0049-4910 Zoloft sertraline hydrochloride Roerig NDA Current 0049-4910 Zoloft sertraline hydrochloride Roerig NDA Current 0049-4910 Zoloft sertraline hydrochloride Roerig NDA Current 0049-4910 Zoloft sertraline hydrochloride Roerig NDA Current 0049-4910 Zoloft sertraline hydrochloride Roerig NDA Current 0049-4910 Zoloft sertraline hydrochloride Roerig NDA Current 0049-4910 Zoloft sertraline hydrochloride Roerig NDA Current 0049-4910 Zoloft sertraline hydrochloride Roerig NDA Current 0049-4910 Zoloft sertraline hydrochloride Roerig NDA Current 0049-4960 Zoloft sertraline hydrochloride Roerig NDA Current 0049-4960 Zoloft sertraline hydrochloride Roerig NDA Current 0049-4960 Zoloft sertraline hydrochloride Roerig NDA Current 0049-4960 Zoloft sertraline hydrochloride Roerig NDA Current 0049-4960 Zoloft sertraline hydrochloride Roerig NDA Current 0049-4960 Zoloft sertraline hydrochloride Roerig NDA Current 0049-4960 Zoloft sertraline hydrochloride Roerig NDA Current 0049-4960 Zoloft sertraline hydrochloride Roerig NDA Current 0049-4960 Zoloft sertraline hydrochloride Roerig NDA Current 0049-4960 Zoloft sertraline hydrochloride Roerig NDA Current 43063-411 SERTRALINE HYDROCHLORIDE sertraline hydrochloride PD-Rx Pharmaceuticals, Inc. NDA AUTHORIZED GENERIC Current 43063-411 SERTRALINE HYDROCHLORIDE sertraline hydrochloride PD-Rx Pharmaceuticals, Inc. NDA AUTHORIZED GENERIC Current 53808-0582 SERTRALINE HYDROCHLORIDE sertraline hydrochloride State of Florida DOH Central Pharmacy NDA Current 55154-0527 SERTRALINE HYDROCHLORIDE sertraline hydrochloride Cardinal Health NDA Current 55154-0532 SERTRALINE HYDROCHLORIDE sertraline hydrochloride Cardinal Health NDA Current 55289-381 SERTRALINE HYDROCHLORIDE sertraline hydrochloride PD-Rx Pharmaceuticals, In NDA AUTHORIZED Current 55289-381 SERTRALINE HYDROCHLORIDE sertraline hydrochloride PD-Rx Pharmaceuticals, Inc. NDA AUTHORIZED GENERIC Current 55289-409 Zoloft sertraline hydrochloride PD-Rx Pharmaceuticals, In NDA Current 55289-409 Zoloft sertraline hydrochloride PD-Rx Pharmaceuticals, Inc. NDA Current 55289-409 Zoloft sertraline hydrochloride PD-Rx Pharmaceuticals, Inc. NDA Current 55289-409 Zoloft sertraline hydrochloride PD-Rx Pharmaceuticals, Inc. NDA Current 55289-409 Zoloft sertraline hydrochloride PD-Rx Pharmaceuticals, Inc. NDA Current 55289-409 Zoloft sertraline hydrochloride PD-Rx Pharmaceuticals, Inc. NDA Current 55289-409 Zoloft sertraline hydrochloride PD-Rx Pharmaceuticals, Inc. NDA Current 59762-4900 SERTRALINE HYDROCHLORIDE sertraline hydrochloride Greenstone LLC NDA AUTHORIZED GENERIC Current 59762-4900 SERTRALINE HYDROCHLORIDE sertraline hydrochloride Greenstone LLC NDA AUTHORIZED GENERIC Current 59762-4910 SERTRALINE HYDROCHLORIDE sertraline hydrochloride Greenstone LLC NDA AUTHORIZED GENERIC Current 59762-4960 SERTRALINE HYDROCHLORIDE sertraline hydrochloride Greenstone LLC NDA AUTHORIZED GENERIC Current 59762-5160 SERTRALINE HYDROCHLORIDE sertraline hydrochloride Greenstone LLC NDA AUTHORIZED GENERIC Current 59762-5160 SERTRALINE HYDROCHLORIDE sertraline hydrochloride Greenstone LLC NDA AUTHORIZED GENERIC Current 59762-5160 SERTRALINE HYDROCHLORIDE sertraline hydrochloride Greenstone LLC NDA AUTHORIZED GENERIC Current 59762-5160 SERTRALINE HYDROCHLORIDE sertraline hydrochloride Greenstone LLC NDA AUTHORIZED GENERIC Current 59762-5160 SERTRALINE HYDROCHLORIDE sertraline hydrochloride Greenstone LLC NDA AUTHORIZED GENERIC Current 59762-6347 SERTRALINE HYDROCHLORIDE sertraline hydrochloride Greenstone LLC NDA AUTHORIZED GENERIC Current 59762-6347 SERTRALINE HYDROCHLORIDE sertraline hydrochloride Greenstone LLC NDA AUTHORIZED GENERIC Current 59762-6347 SERTRALINE HYDROCHLORIDE sertraline hydrochloride Greenstone LLC NDA AUTHORIZED GENERIC Current 59762-6347 SERTRALINE HYDROCHLORIDE sertraline hydrochloride Greenstone LLC NDA AUTHORIZED GENERIC Current 59762-6347 SERTRALINE HYDROCHLORIDE sertraline hydrochloride Greenstone LLC NDA AUTHORIZED GENERIC Current 59762-6443 SERTRALINE HYDROCHLORIDE sertraline hydrochloride Greenstone LLC NDA AUTHORIZED GENERIC Current 59762-6443 SERTRALINE HYDROCHLORIDE sertraline hydrochloride Greenstone LLC NDA AUTHORIZED GENERIC Current 59762-6443 SERTRALINE HYDROCHLORIDE sertraline hydrochloride Greenstone LLC NDA AUTHORIZED GENERIC Current 59762-6443 SERTRALINE HYDROCHLORIDE sertraline hydrochloride Greenstone LLC NDA AUTHORIZED GENERIC Current 59762-6443 SERTRALINE HYDROCHLORIDE sertraline hydrochloride Greenstone LLC NDA AUTHORIZED GENERIC Current 63629-6755 SERTRALINE HYDROCHLORIDE sertraline hydrochloride Bryant Ranch Prepack NDA AUTHORIZED GENERIC Current 63629-6755 SERTRALINE HYDROCHLORIDE sertraline hydrochloride Bryant Ranch Prepack NDA AUTHORIZED GENERIC Current 67046-665 SERTRALINE HYDROCHLORIDE sertraline hydrochloride Contract Pharmacy Services-PA NDA Current 67544-080 Zoloft SERTRALINE HYDROCHLORIDE Aphena Pharma Solutions - Tennessee, LLC NDA Current 67544-298 Zoloft SERTRALINE HYDROCHLORIDE Aphena Pharma Solutions - Tennessee, LLC NDA Current 70518-1913 Zoloft sertraline hydrochloride REMEDYREPACK INC. NDA Current 70518-1913 Zoloft sertraline hydrochloride REMEDYREPACK INC. NDA Current 70518-1913 Zoloft sertraline hydrochloride REMEDYREPACK INC. NDA Current 70518-1913 Zoloft sertraline hydrochloride REMEDYREPACK INC. NDA Current 71610-433 SERTRALINE HYDROCHLORIDE sertraline hydrochloride Aphena Pharma Solutions - Tennessee, LLC NDA AUTHORIZED GENERIC Current 75921-490 SERTRALINE HYDROCHLORIDE sertraline hydrochloride Life Line Home Care Services NDA Current