FDA.reportPublic FDA data

Application 085472

Type
ANDA
Sponsor
VALEANT PHARM INTL

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LIBRIUMCHLORDIAZEPOXIDE HYDROCHLORIDECAPSULE;ORAL10MGNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A085472-001LIBRIUMCHLORDIAZEPOXIDE HYDROCHLORIDE10MGCAPSULE / ORALABRLD, Approved before 1982

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A085472-001AB

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 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10A085472-001LIBRIUM10MGCAPSULE / ORALABRLD, Approved before 1982f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A085472-001LIBRIUM10MGCAPSULE / ORALABRLD, Approved before 1982e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A085472-001LIBRIUM10MGCAPSULE / ORALABRLD, Approved before 1982cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A085472-001LIBRIUM10MGCAPSULE / ORALABRLD, Approved before 1982a50c72e98297…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-10-15 13:18:302026-09A085472-001AB1c2088c7a36db…
2026-09-14 22:38:342026-08A085472-001AB184e616aacf4f…
2026-08-18 06:07:402026-07A085472-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A085472-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A085472-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A085472-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A085472-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A085472-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A085472-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A085472-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A085472-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A085472-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A085472-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A085472-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A085472-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A085472-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A085472-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A085472-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A085472-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A085472-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A085472-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A085472-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A085472-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A085472-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A085472-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A085472-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A085472-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A085472-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A085472-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A085472-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A085472-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A085472-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A085472-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A085472-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A085472-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A085472-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A085472-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A085472-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A085472-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A085472-001AB13a93d1ddd44b…

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
CHLORDIAZEPOXIDE HYDROCHLORIDECHLORDIAZEPOXIDE HYDROCHLORIDEEpic Pharma, LLC2e198c16-a929-4028-8f96-25dd23f74b102023-02-07Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 085472
application number: ANDA085472
ndc (product): 42806-565
CHLORDIAZEPOXIDE HYDROCHLORIDECHLORDIAZEPOXIDE HYDROCHLORIDEEpic Pharma LLC8255992f-3256-4558-bd0d-cfe350d95f252022-03-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 085472
application number: ANDA085472
ndc (product): 42806-562

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 · 18 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
42291-211Chlordiazepoxide HydrochlorideChlordiazepoxide HydrochlorideAvKARE, Inc.ANDACurrent
42291-211Chlordiazepoxide HydrochlorideChlordiazepoxide HydrochlorideAvKARE, Inc.ANDACurrent
42291-211Chlordiazepoxide HydrochlorideChlordiazepoxide HydrochlorideAvKARE, Inc.ANDACurrent
42806-562CHLORDIAZEPOXIDE HYDROCHLORIDECHLORDIAZEPOXIDE HYDROCHLORIDEEpic Pharma LLCANDACurrent
42806-562CHLORDIAZEPOXIDE HYDROCHLORIDECHLORDIAZEPOXIDE HYDROCHLORIDEEpic Pharma LLCANDACurrent
42806-565CHLORDIAZEPOXIDE HYDROCHLORIDECHLORDIAZEPOXIDE HYDROCHLORIDEEpic Pharma LLCANDACurrent
42806-565CHLORDIAZEPOXIDE HYDROCHLORIDECHLORDIAZEPOXIDE HYDROCHLORIDEEpic Pharma LLCANDACurrent
43353-969Chlordiazepoxide HydrochlorideChlordiazepoxide HydrochlorideAphena Pharma Solutions - Tennessee, LLCANDACurrent
43547-252Chlordiazepoxide HydrochlorideChlordiazepoxide HydrochlorideSolco Healthcare US LLCANDACurrent
43547-252Chlordiazepoxide HydrochlorideChlordiazepoxide HydrochlorideSolco Healthcare US LLCANDACurrent
43547-252Chlordiazepoxide HydrochlorideChlordiazepoxide HydrochlorideSolco Healthcare US LLCANDACurrent
43547-252Chlordiazepoxide HydrochlorideChlordiazepoxide HydrochlorideSolco Healthcare US LLCANDACurrent
60429-555Chlordiazepoxide HydrochlorideChlordiazepoxide HydrochlorideGolden State Medical Supply, Inc.ANDACurrent
60429-555Chlordiazepoxide HydrochlorideChlordiazepoxide HydrochlorideGolden State Medical Supply, Inc.ANDACurrent
60429-555Chlordiazepoxide HydrochlorideChlordiazepoxide HydrochlorideGolden State Medical SupplyANDACurrent
60429-555Chlordiazepoxide HydrochlorideChlordiazepoxide HydrochlorideGolden State Medical Supply, Inc.ANDACurrent
67046-912Chlordiazepoxide HydrochlorideChlordiazepoxide HydrochlorideContract Pharmacy Services-PAANDACurrent
68071-2145Chlordiazepoxide HydrochlorideChlordiazepoxide HydrochlorideNuCare Pharmaceuticals, Inc.ANDACurrent