Application 018031

Type
NDA
Sponsor
WYETH PHARMS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001INDERIDE-40/25HYDROCHLOROTHIAZIDE; PROPRANOLOL HYDROCHLORIDETABLET;ORAL25MG;40MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo
002INDERIDE-80/25HYDROCHLOROTHIAZIDE; PROPRANOLOL HYDROCHLORIDETABLET;ORAL25MG;80MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N018031-001INDERIDE-40/25HYDROCHLOROTHIAZIDE; PROPRANOLOL HYDROCHLORIDE25MG;40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 1982
N018031-002INDERIDE-80/25HYDROCHLOROTHIAZIDE; PROPRANOLOL HYDROCHLORIDE25MG;80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 1982

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 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N018031-001INDERIDE-40/2525MG;40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02N018031-002INDERIDE-80/2525MG;80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 1982011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018031-001INDERIDE-40/2525MG;40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018031-002INDERIDE-80/2525MG;80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 198231067a03dcf5…
2025-08-23 18:47 UTC2025-08N018031-001INDERIDE-40/2525MG;40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08N018031-002INDERIDE-80/2525MG;80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 19826a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018031-001INDERIDE-40/2525MG;40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018031-002INDERIDE-80/2525MG;80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 1982fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018031-001INDERIDE-40/2525MG;40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 1982b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018031-002INDERIDE-80/2525MG;80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 1982b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018031-001INDERIDE-40/2525MG;40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 198203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018031-002INDERIDE-80/2525MG;80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 198203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018031-001INDERIDE-40/2525MG;40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 19822680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018031-002INDERIDE-80/2525MG;80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 19822680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018031-001INDERIDE-40/2525MG;40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 19825bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018031-002INDERIDE-80/2525MG;80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 19825bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018031-001INDERIDE-40/2525MG;40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 1982d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018031-002INDERIDE-80/2525MG;80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 1982d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N018031-001INDERIDE-40/2525MG;40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 1982d06236e962d9…
2024-10-29 15:01 UTC2024-10N018031-002INDERIDE-80/2525MG;80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 1982d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N018031-001INDERIDE-40/2525MG;40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 198279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N018031-002INDERIDE-80/2525MG;80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 198279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N018031-001INDERIDE-40/2525MG;40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 1982301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N018031-002INDERIDE-80/2525MG;80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 1982301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N018031-001INDERIDE-40/2525MG;40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 19821e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N018031-002INDERIDE-80/2525MG;80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 19821e350fbaab3a…
2024-05-31 18:47 UTC2024-05N018031-001INDERIDE-40/2525MG;40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 19828072bd15b7f6…
2024-05-31 18:47 UTC2024-05N018031-002INDERIDE-80/2525MG;80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 19828072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N018031-001INDERIDE-40/2525MG;40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 19825c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N018031-002INDERIDE-80/2525MG;80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 19825c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N018031-001INDERIDE-40/2525MG;40MGTABLET / ORALRLD, Approved before 19825d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N018031-002INDERIDE-80/2525MG;80MGTABLET / ORALRLD, Approved before 19825d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N018031-001INDERIDE-40/2525MG;40MGTABLET / ORALRLD, Approved before 19824b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N018031-002INDERIDE-80/2525MG;80MGTABLET / ORALRLD, Approved before 19824b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N018031-001INDERIDE-40/2525MG;40MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**TABLET / ORALRLD, Approved before 198274a2ff9319b5…
2019-12-13 00:20 UTC2019-12N018031-002INDERIDE-80/2525MG;80MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**TABLET / ORALRLD, Approved before 198274a2ff9319b5…
2022-03-09 01:35 UTC2022-03N018031-001INDERIDE-40/2525MG;40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 1982bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N018031-002INDERIDE-80/2525MG;80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 1982bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N018031-001INDERIDE-40/2525MG;40MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**TABLET / ORALRLD, Approved before 1982782e0a99824c…
2021-12-28 21:50 UTC2021-12N018031-002INDERIDE-80/2525MG;80MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**TABLET / ORALRLD, Approved before 1982782e0a99824c…

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
13991SUPPL2011-03-23
802SUPPL2011-03-23
33402SUPPL2011-03-21
11128SUPPL2011-03-21
13990SUPPL2010-03-08
11127SUPPL2010-03-05
13989SUPPL2008-01-09
11126SUPPL2008-01-08
801SUPPL2007-03-06
13988SUPPL2007-01-08
800SUPPL2004-06-10