FDA.reportPublic FDA data

Application 050757

Type
NDA
Sponsor
TAKEDA PHARMS USA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PREVPACAMOXICILLIN; CLARITHROMYCIN; LANSOPRAZOLECAPSULE, CAPSULE, DELAYED REL PELLETS, TABLET;ORAL500MG,N/A,N/A;N/A,500MG,N/A;N/A,N/A,30MGYesNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
N050757-001PREVPAC (COPACKAGED)AMOXICILLIN; CLARITHROMYCIN; LANSOPRAZOLE500MG;500MG;30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS / ORALRLD1997-12-02

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 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N050757-001PREVPAC (COPACKAGED)500MG;500MG;30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS / ORALRLD1997-12-0284e616aacf4f…
2026-08-18 06:07:402026-07N050757-001PREVPAC (COPACKAGED)500MG;500MG;30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS / ORALRLD1997-12-02caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N050757-001PREVPAC (COPACKAGED)500MG;500MG;30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS / ORALRLD1997-12-02011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N050757-001PREVPAC (COPACKAGED)500MG;500MG;30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS / ORALRLD1997-12-0231067a03dcf5…
2025-08-23 18:47 UTC2025-08N050757-001PREVPAC (COPACKAGED)500MG;500MG;30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS / ORALRLD1997-12-026a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N050757-001PREVPAC (COPACKAGED)500MG;500MG;30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS / ORALRLD1997-12-02fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N050757-001PREVPAC (COPACKAGED)500MG;500MG;30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS / ORALRLD1997-12-02b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N050757-001PREVPAC (COPACKAGED)500MG;500MG;30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS / ORALRLD1997-12-0203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N050757-001PREVPAC (COPACKAGED)500MG;500MG;30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS / ORALRLD1997-12-022680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N050757-001PREVPAC (COPACKAGED)500MG;500MG;30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS / ORALRLD1997-12-025bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N050757-001PREVPAC (COPACKAGED)500MG;500MG;30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS / ORALRLD1997-12-02d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N050757-001PREVPAC (COPACKAGED)500MG;500MG;30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS / ORALRLD1997-12-02d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N050757-001PREVPAC (COPACKAGED)500MG;500MG;30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS / ORALRLD1997-12-0279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N050757-001PREVPAC (COPACKAGED)500MG;500MG;30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS / ORALRLD1997-12-02301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N050757-001PREVPAC (COPACKAGED)500MG;500MG;30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS / ORALRLD1997-12-021e350fbaab3a…
2024-05-31 18:47 UTC2024-05N050757-001PREVPAC (COPACKAGED)500MG;500MG;30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS / ORALRLD1997-12-028072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N050757-001PREVPAC (COPACKAGED)500MG;500MG;30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS / ORALRLD1997-12-025c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N050757-001PREVPAC (COPACKAGED)500MG;500MG;30MGCAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS / ORALRLD1997-12-025d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N050757-001PREVPAC (COPACKAGED)500MG;500MG;30MGCAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS / ORALRLD1997-12-024b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N050757-001PREVPAC500MG,N/A,N/A;N/A,500MG,N/A;N/A,N/A,30MGCAPSULE, CAPSULE, DELAYED REL PELLETS, TABLET / ORALRLD1997-12-0274a2ff9319b5…
2022-03-09 01:35 UTC2022-03N050757-001PREVPAC (COPACKAGED)500MG;500MG;30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS / ORALRLD1997-12-02bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N050757-001PREVPAC (COPACKAGED)500MG;500MG;30MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS / ORALRLD1997-12-02782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N050757-001PREVPAC500MG,N/A,N/A;N/A,500MG,N/A;N/A,N/A,30MGCAPSULE, CAPSULE, DELAYED REL PELLETS, TABLET / ORALRLD1997-12-0287673890dc5c…
2021-03-12 10:30 UTC2021-03N050757-001PREVPAC500MG,N/A,N/A;N/A,500MG,N/A;N/A,N/A,30MGCAPSULE, CAPSULE, DELAYED REL PELLETS, TABLET / ORALRLD1997-12-025aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N050757-001PREVPAC500MG,N/A,N/A;N/A,500MG,N/A;N/A,N/A,30MGCAPSULE, CAPSULE, DELAYED REL PELLETS, TABLET / ORALRLD1997-12-028869cabd3fbd…
2020-11-12 02:37 UTC2020-11N050757-001PREVPAC500MG,N/A,N/A;N/A,500MG,N/A;N/A,N/A,30MGCAPSULE, CAPSULE, DELAYED REL PELLETS, TABLET / ORALRLD1997-12-02c0c555d07b60…
2019-12-14 00:12 UTC2019-12N050757-001PREVPAC500MG,N/A,N/A;N/A,500MG,N/A;N/A,N/A,30MGCAPSULE, CAPSULE, DELAYED REL PELLETS, TABLET / ORALRLD1997-12-023f01610625f2…
2019-09-15 20:21 UTC2019-09N050757-001PREVPAC500MG,N/A,N/A;N/A,500MG,N/A;N/A,N/A,30MGCAPSULE, CAPSULE, DELAYED REL PELLETS, TABLET / ORALRLD1997-12-02b00525d2431f…
2019-07-19 19:46 UTC2019-07N050757-001PREVPAC500MG,N/A,N/A;N/A,500MG,N/A;N/A,N/A,30MGCAPSULE, CAPSULE, DELAYED REL PELLETS, TABLET / ORALRLD1997-12-02ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N050757-001PREVPAC (COPACKAGED)500MG;500MG;30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS / ORALRLD1997-12-026a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N050757-001PREVPAC (COPACKAGED)500MG;500MG;30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS / ORALRLD1997-12-021c564ffb4f44…
2023-12-20 04:57 UTC2023-12N050757-001PREVPAC (COPACKAGED)500MG;500MG;30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS / ORALRLD1997-12-02ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N050757-001PREVPAC (COPACKAGED)500MG;500MG;30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS / ORALRLD1997-12-02a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N050757-001PREVPAC (COPACKAGED)500MG;500MG;30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS / ORALRLD1997-12-029b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N050757-001PREVPAC (COPACKAGED)500MG;500MG;30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS / ORALRLD1997-12-02a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N050757-001PREVPAC (COPACKAGED)500MG;500MG;30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS / ORALRLD1997-12-023f0d92c62455…
2023-05-13 08:27 UTC2023-05N050757-001PREVPAC (COPACKAGED)500MG;500MG;30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS / ORALRLD1997-12-02053a50430f4f…
2023-01-26 05:58 UTC2023-01N050757-001PREVPAC (COPACKAGED)500MG;500MG;30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS / ORALRLD1997-12-023bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N050757-001PREVPAC (COPACKAGED)500MG;500MG;30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS / ORALRLD1997-12-023a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N050757-001PREVPAC (COPACKAGED)500MG;500MG;30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS / ORALRLD1997-12-02f41ea6bd6efb…

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 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
64764-702PREVPAClansoprazole, amoxicillin and clarithromycinTakeda Pharmaceuticals America, Inc.NDACurrent
64764-702PREVPAClansoprazole, amoxicillin and clarithromycinTakeda Pharmaceuticals America, Inc.NDACurrent
66993-418lansoprazole, amoxicillin and clarithromycinlansoprazole, amoxicillin and clarithromycinPrasco LaboratoriesNDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
54586SUPPL2018-06-14
54535SUPPL2018-06-12
50565SUPPL2017-12-01
50530SUPPL2017-11-30
47449SUPPL2017-03-03
47392SUPPL2017-03-02
45724SUPPL2016-10-31
45650SUPPL2016-10-26
8212SUPPL2014-12-23
39275SUPPL2014-12-22
39274SUPPL2013-11-08
30470SUPPL2013-11-08
8211SUPPL2009-04-03
8210SUPPL2007-11-08
18189SUPPL2007-11-07
8209SUPPL2007-06-04
30469SUPPL2006-08-14
8208SUPPL2006-08-14
39273SUPPL2005-04-28
30468SUPPL2005-04-28
30467SUPPL2004-07-30
8207SUPPL2004-07-30
39272SUPPL2004-06-14
30466SUPPL2004-06-14
39271SUPPL2002-11-22
30465SUPPL2002-11-22
42720SUPPL1999-10-22
30464SUPPL1999-10-22
18188SUPPL1999-10-22
39270SUPPL1999-08-20
30463SUPPL1999-08-20
22225SUPPL1999-08-20
39269SUPPL1999-01-22
22224SUPPL1999-01-22
8206SUPPL1999-01-22
42719ORIG1997-12-02