Application 020990

Type
NDA
Sponsor
PFIZER

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ZOLOFTSERTRALINE HYDROCHLORIDECONCENTRATE;ORALEQ 20MG BASE/MLYesYes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N020990-001ZOLOFTSERTRALINE HYDROCHLORIDEEQ 20MG BASE/MLCONCENTRATE / ORALAARLD, RS1999-12-07

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
N020990-001AA

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 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N020990-001ZOLOFTEQ 20MG BASE/MLCONCENTRATE / ORALAARLD, RS1999-12-07caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N020990-001ZOLOFTEQ 20MG BASE/MLCONCENTRATE / ORALAARLD, RS1999-12-07011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020990-001ZOLOFTEQ 20MG BASE/MLCONCENTRATE / ORALAARLD, RS1999-12-0731067a03dcf5…
2025-08-23 18:47 UTC2025-08N020990-001ZOLOFTEQ 20MG BASE/MLCONCENTRATE / ORALAARLD, RS1999-12-076a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020990-001ZOLOFTEQ 20MG BASE/MLCONCENTRATE / ORALAARLD, RS1999-12-07fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020990-001ZOLOFTEQ 20MG BASE/MLCONCENTRATE / ORALAARLD, RS1999-12-07b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020990-001ZOLOFTEQ 20MG BASE/MLCONCENTRATE / ORALAARLD, RS1999-12-0703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020990-001ZOLOFTEQ 20MG BASE/MLCONCENTRATE / ORALAARLD, RS1999-12-072680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020990-001ZOLOFTEQ 20MG BASE/MLCONCENTRATE / ORALAARLD, RS1999-12-075bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020990-001ZOLOFTEQ 20MG BASE/MLCONCENTRATE / ORALAARLD, RS1999-12-07d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N020990-001ZOLOFTEQ 20MG BASE/MLCONCENTRATE / ORALAARLD, RS1999-12-07d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020990-001ZOLOFTEQ 20MG BASE/MLCONCENTRATE / ORALAARLD, RS1999-12-0779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020990-001ZOLOFTEQ 20MG BASE/MLCONCENTRATE / ORALAARLD, RS1999-12-07301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020990-001ZOLOFTEQ 20MG BASE/MLCONCENTRATE / ORALAARLD, RS1999-12-071e350fbaab3a…
2024-05-31 18:47 UTC2024-05N020990-001ZOLOFTEQ 20MG BASE/MLCONCENTRATE / ORALAARLD, RS1999-12-078072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N020990-001ZOLOFTEQ 20MG BASE/MLCONCENTRATE / ORALAARLD, RS1999-12-075c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N020990-001ZOLOFTEQ 20MG BASE/MLCONCENTRATE / ORALAARLD, RS1999-12-075d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N020990-001ZOLOFTEQ 20MG BASE/MLCONCENTRATE / ORALAARLD, RS1999-12-074b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N020990-001ZOLOFTEQ 20MG BASE/MLCONCENTRATE / ORALAARLD, RS1999-12-0774a2ff9319b5…
2022-03-09 01:35 UTC2022-03N020990-001ZOLOFTEQ 20MG BASE/MLCONCENTRATE / ORALAARLD, RS1999-12-07bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N020990-001ZOLOFTEQ 20MG BASE/MLCONCENTRATE / ORALAARLD, RS1999-12-07782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N020990-001ZOLOFTEQ 20MG BASE/MLCONCENTRATE / ORALAARLD, RS1999-12-0787673890dc5c…
2021-03-12 10:30 UTC2021-03N020990-001ZOLOFTEQ 20MG BASE/MLCONCENTRATE / ORALAARLD, RS1999-12-075aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N020990-001ZOLOFTEQ 20MG BASE/MLCONCENTRATE / ORALAARLD, RS1999-12-078869cabd3fbd…
2020-11-12 02:37 UTC2020-11N020990-001ZOLOFTEQ 20MG BASE/MLCONCENTRATE / ORALAARLD, RS1999-12-07c0c555d07b60…
2019-12-14 00:12 UTC2019-12N020990-001ZOLOFTEQ 20MG BASE/MLCONCENTRATE / ORALAARLD, RS1999-12-073f01610625f2…
2019-09-15 20:21 UTC2019-09N020990-001ZOLOFTEQ 20MG BASE/MLCONCENTRATE / ORALAARLD, RS1999-12-07b00525d2431f…
2019-07-19 19:46 UTC2019-07N020990-001ZOLOFTEQ 20MG BASE/MLCONCENTRATE / ORALAARLD, RS1999-12-07ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N020990-001ZOLOFTEQ 20MG BASE/MLCONCENTRATE / ORALAARLD, RS1999-12-076a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N020990-001ZOLOFTEQ 20MG BASE/MLCONCENTRATE / ORALAARLD, RS1999-12-071c564ffb4f44…
2023-12-20 04:57 UTC2023-12N020990-001ZOLOFTEQ 20MG BASE/MLCONCENTRATE / ORALAARLD, RS1999-12-07ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N020990-001ZOLOFTEQ 20MG BASE/MLCONCENTRATE / ORALAARLD, RS1999-12-07a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N020990-001ZOLOFTEQ 20MG BASE/MLCONCENTRATE / ORALAARLD, RS1999-12-079b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N020990-001ZOLOFTEQ 20MG BASE/MLCONCENTRATE / ORALAARLD, RS1999-12-07a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N020990-001ZOLOFTEQ 20MG BASE/MLCONCENTRATE / ORALAARLD, RS1999-12-073f0d92c62455…
2023-05-13 08:27 UTC2023-05N020990-001ZOLOFTEQ 20MG BASE/MLCONCENTRATE / ORALAARLD, RS1999-12-07053a50430f4f…
2023-01-26 05:58 UTC2023-01N020990-001ZOLOFTEQ 20MG BASE/MLCONCENTRATE / ORALAARLD, RS1999-12-073bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N020990-001ZOLOFTEQ 20MG BASE/MLCONCENTRATE / ORALAARLD, RS1999-12-073a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N020990-001ZOLOFTEQ 20MG BASE/MLCONCENTRATE / ORALAARLD, RS1999-12-07f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N020990-001ZOLOFTEQ 20MG BASE/MLCONCENTRATE / ORALAARLD, RS1999-12-07e64feba35796…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07N020990-001AA1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N020990-001AA1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020990-001AA131067a03dcf5…
2025-08-23 18:47 UTC2025-08N020990-001AA16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020990-001AA1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020990-001AA1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020990-001AA103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020990-001AA12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020990-001AA15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020990-001AA1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N020990-001AA1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020990-001AA179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020990-001AA1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020990-001AA11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N020990-001AA18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N020990-001AA15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N020990-001AA15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N020990-001AA14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N020990-001AA174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N020990-001AA1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N020990-001AA1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N020990-001AA187673890dc5c…
2021-03-12 10:30 UTC2021-03N020990-001AA15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N020990-001AA18869cabd3fbd…
2020-11-12 02:37 UTC2020-11N020990-001AA1c0c555d07b60…
2019-12-14 00:12 UTC2019-12N020990-001AA13f01610625f2…
2019-09-15 20:21 UTC2019-09N020990-001AA1b00525d2431f…
2019-07-19 19:46 UTC2019-07N020990-001AA1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N020990-001AA16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N020990-001AA11c564ffb4f44…
2023-12-20 04:57 UTC2023-12N020990-001AA1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N020990-001AA1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N020990-001AA19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N020990-001AA1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N020990-001AA13f0d92c62455…
2023-05-13 08:27 UTC2023-05N020990-001AA1053a50430f4f…
2023-01-26 05:58 UTC2023-01N020990-001AA13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N020990-001AA13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N020990-001AA1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N020990-001AA1e64feba35796…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2019-12-13 00:20 UTC2019-12N020990-00167272832019-10-11U-580Drug product74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N020990-00170675552019-10-11Drug product74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N020990-0016727283*PED2020-04-11Pediatric extension74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N020990-0017067555*PED2020-04-11Pediatric extension74a2ff9319b5…
2020-12-22 03:56 UTC2020-12N020990-0016727283*PED2020-04-11Pediatric extension8869cabd3fbd…
2020-12-22 03:56 UTC2020-12N020990-0017067555*PED2020-04-11Pediatric extension8869cabd3fbd…
2020-11-12 02:37 UTC2020-11N020990-0016727283*PED2020-04-11Pediatric extensionc0c555d07b60…
2020-11-12 02:37 UTC2020-11N020990-0017067555*PED2020-04-11Pediatric extensionc0c555d07b60…
2019-12-14 00:12 UTC2019-12N020990-00167272832019-10-11U-580Drug product3f01610625f2…
2019-12-14 00:12 UTC2019-12N020990-00170675552019-10-11Drug product3f01610625f2…
2019-12-14 00:12 UTC2019-12N020990-0016727283*PED2020-04-11Pediatric extension3f01610625f2…
2019-12-14 00:12 UTC2019-12N020990-0017067555*PED2020-04-11Pediatric extension3f01610625f2…
2019-09-15 20:21 UTC2019-09N020990-00167272832019-10-11U-580Drug productb00525d2431f…
2019-09-15 20:21 UTC2019-09N020990-00170675552019-10-11Drug productb00525d2431f…
2019-09-15 20:21 UTC2019-09N020990-0016727283*PED2020-04-11Pediatric extensionb00525d2431f…
2019-09-15 20:21 UTC2019-09N020990-0017067555*PED2020-04-11Pediatric extensionb00525d2431f…
2019-07-19 19:46 UTC2019-07N020990-00167272832019-10-11U-580Drug productea99ee380514…
2019-07-19 19:46 UTC2019-07N020990-00170675552019-10-11Drug productea99ee380514…
2019-07-19 19:46 UTC2019-07N020990-0016727283*PED2020-04-11Pediatric extensionea99ee380514…
2019-07-19 19:46 UTC2019-07N020990-0017067555*PED2020-04-11Pediatric extensionea99ee380514…

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sertraline hydrochlorideSERTRALINE HYDROCHLORIDEMylan Pharmaceuticals Inc.1a58062b-e635-431a-908d-2651c6a4a21c2024-09-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 020990
application number: NDA020990
ndc (product): 59762-0067
ZoloftSERTRALINE HYDROCHLORIDEViatris Specialty LLCfda754f6-d0f3-4dce-a17a-927d64f912f72023-08-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 020990
application number: NDA020990

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 23 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0049-0050Zoloftsertraline hydrochlorideRoerigNDACurrent
0049-0050Zoloftsertraline hydrochlorideRoerigNDACurrent
0049-0050Zoloftsertraline hydrochlorideRoerigNDACurrent
0049-0050Zoloftsertraline hydrochlorideRoerigNDACurrent
0049-0050Zoloftsertraline hydrochlorideRoerigNDACurrent
0049-0050Zoloftsertraline hydrochlorideRoerigNDACurrent
0049-0050Zoloftsertraline hydrochlorideRoerigNDACurrent
0049-0050Zoloftsertraline hydrochlorideRoerigNDACurrent
0049-0050Zoloftsertraline hydrochlorideRoerigNDACurrent
0049-0050Zoloftsertraline hydrochlorideRoerigNDACurrent
0049-4940Zoloftsertraline hydrochlorideRoerigNDACurrent
59762-0067SERTRALINE HYDROCHLORIDEsertraline hydrochlorideGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-0067SERTRALINE HYDROCHLORIDEsertraline hydrochlorideGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-0067SERTRALINE HYDROCHLORIDEsertraline hydrochlorideGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-0067SERTRALINE HYDROCHLORIDEsertraline hydrochlorideGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-0067SERTRALINE HYDROCHLORIDEsertraline hydrochlorideGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-0067SERTRALINE HYDROCHLORIDEsertraline hydrochlorideGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-0067SERTRALINE HYDROCHLORIDEsertraline hydrochlorideGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-4940SERTRALINE HYDROCHLORIDEsertraline hydrochlorideGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-4940SERTRALINE HYDROCHLORIDEsertraline hydrochlorideGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-4940SERTRALINE HYDROCHLORIDEsertraline hydrochlorideGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-4940SERTRALINE HYDROCHLORIDEsertraline hydrochlorideGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-4940SERTRALINE HYDROCHLORIDEsertraline hydrochlorideGreenstone LLCNDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
75231SUPPL 2023-08-22
75210SUPPL 2023-08-22
75209SUPPL 2023-08-22
73312SUPPL2023-01-30
73311SUPPL2023-01-30
73293SUPPL2023-01-26
68707SUPPL2021-09-21
68706SUPPL2021-09-21
68674SUPPL2021-09-21
50723SUPPL2017-12-18
50722SUPPL2017-12-18
50669SUPPL2017-12-12
50668SUPPL2017-12-12
50667SUPPL2017-12-12
48747SUPPL2017-06-16
48726SUPPL2017-06-16
46552SUPPL2016-12-27
46551SUPPL2016-12-27
46550SUPPL2016-12-27
46537SUPPL2016-12-27
46536SUPPL2016-12-27
46535SUPPL2016-12-27
35840SUPPL2014-09-19
3996SUPPL2014-09-16
35839SUPPL2014-07-08
35838SUPPL2014-07-08
3995SUPPL2014-07-08
3994SUPPL2014-07-08
14121SUPPL2013-02-06
3993SUPPL2013-02-04
14122SUPPL2012-12-28
14119SUPPL2012-12-28
26428SUPPL2012-12-21
3992SUPPL2012-12-21
35837SUPPL2011-08-24
35836SUPPL2011-08-24
14120SUPPL2011-08-24
26427SUPPL2011-08-22
26426SUPPL2011-08-22
3991SUPPL2011-08-22
14118SUPPL2009-02-04
3990SUPPL2009-02-03
35835SUPPL2008-03-07
26425SUPPL2008-03-07
35834SUPPL2007-10-10
26424SUPPL2007-10-10
26422SUPPL2007-08-07
3989SUPPL2007-08-07
14117SUPPL2007-08-03
21334SUPPL2007-03-02
35833SUPPL2006-09-15
26423SUPPL2006-09-15
14116SUPPL2006-09-15
3988SUPPL2006-09-15
3987SUPPL2006-05-16
26421SUPPL2005-07-29
23616ORIG2005-07-29
14115SUPPL2005-07-14
14114SUPPL2005-07-14
26420SUPPL2005-02-23
3986SUPPL2005-02-23
35832SUPPL2004-08-25
26419SUPPL2004-08-25
14113SUPPL2004-08-25
3985SUPPL2004-08-25
26418SUPPL2004-07-01
35831SUPPL2003-09-25
26417SUPPL2003-09-25
3983SUPPL2003-07-31
26413SUPPL2003-07-23
35828SUPPL2003-04-25
14112SUPPL2003-03-05
3984SUPPL2002-09-20
26416SUPPL2002-09-18
35830SUPPL2002-05-16
26415SUPPL2002-05-16
35829SUPPL2001-08-17
26414SUPPL2001-08-17
21333SUPPL2001-08-17
26412ORIG1999-12-07
21332ORIG1999-12-07
14111ORIG1999-12-07