Application 071321

Type
ANDA
Sponsor
IVAX SUB TEVA PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DIAZEPAMDIAZEPAMTABLET;ORAL5MGNoNo

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

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
A071321-001DIAZEPAMDIAZEPAM5MGTABLET / ORALAB1986-12-10

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A071321-001AB

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 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A071321-001DIAZEPAM5MGTABLET / ORALAB1986-12-10011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A071321-001DIAZEPAM5MGTABLET / ORALAB1986-12-1031067a03dcf5…
2025-08-23 18:47 UTC2025-08A071321-001DIAZEPAM5MGTABLET / ORALAB1986-12-106a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A071321-001DIAZEPAM5MGTABLET / ORALAB1986-12-10fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A071321-001DIAZEPAM5MGTABLET / ORALAB1986-12-10b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A071321-001DIAZEPAM5MGTABLET / ORALAB1986-12-1003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A071321-001DIAZEPAM5MGTABLET / ORALAB1986-12-102680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A071321-001DIAZEPAM5MGTABLET / ORALAB1986-12-105bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A071321-001DIAZEPAM5MGTABLET / ORALAB1986-12-10d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A071321-001DIAZEPAM5MGTABLET / ORALAB1986-12-10d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A071321-001DIAZEPAM5MGTABLET / ORALAB1986-12-1079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A071321-001DIAZEPAM5MGTABLET / ORALAB1986-12-10301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A071321-001DIAZEPAM5MGTABLET / ORALAB1986-12-101e350fbaab3a…
2024-05-31 18:47 UTC2024-05A071321-001DIAZEPAM5MGTABLET / ORALAB1986-12-108072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A071321-001DIAZEPAM5MGTABLET / ORALAB1986-12-105c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A071321-001DIAZEPAM5MGTABLET / ORALAB1986-12-105d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A071321-001DIAZEPAM5MGTABLET / ORALAB1986-12-104b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A071321-001DIAZEPAM5MGTABLET / ORALAB1986-12-1074a2ff9319b5…
2022-03-09 01:35 UTC2022-03A071321-001DIAZEPAM5MGTABLET / ORALAB1986-12-10bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A071321-001DIAZEPAM5MGTABLET / ORALAB1986-12-10782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A071321-001DIAZEPAM5MGTABLET / ORALAB1986-12-1087673890dc5c…
2021-03-12 10:30 UTC2021-03A071321-001DIAZEPAM5MGTABLET / ORALAB1986-12-105aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A071321-001DIAZEPAM5MGTABLET / ORALAB1986-12-108869cabd3fbd…
2020-11-12 02:37 UTC2020-11A071321-001DIAZEPAM5MGTABLET / ORALAB1986-12-10c0c555d07b60…
2019-12-14 00:12 UTC2019-12A071321-001DIAZEPAM5MGTABLET / ORALAB1986-12-103f01610625f2…
2019-09-15 20:21 UTC2019-09A071321-001DIAZEPAM5MGTABLET / ORALAB1986-12-10b00525d2431f…
2019-07-19 19:46 UTC2019-07A071321-001DIAZEPAM5MGTABLET / ORALAB1986-12-10ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A071321-001DIAZEPAM5MGTABLET / ORALAB1986-12-106a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A071321-001DIAZEPAM5MGTABLET / ORALAB1986-12-101c564ffb4f44…
2023-12-20 04:57 UTC2023-12A071321-001DIAZEPAM5MGTABLET / ORALAB1986-12-10ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A071321-001DIAZEPAM5MGTABLET / ORALAB1986-12-10a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A071321-001DIAZEPAM5MGTABLET / ORALAB1986-12-109b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A071321-001DIAZEPAM5MGTABLET / ORALAB1986-12-10a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A071321-001DIAZEPAM5MGTABLET / ORALAB1986-12-103f0d92c62455…
2023-05-13 08:27 UTC2023-05A071321-001DIAZEPAM5MGTABLET / ORALAB1986-12-10053a50430f4f…
2023-01-26 05:58 UTC2023-01A071321-001DIAZEPAM5MGTABLET / ORALAB1986-12-103bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A071321-001DIAZEPAM5MGTABLET / ORALAB1986-12-103a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A071321-001DIAZEPAM5MGTABLET / ORALAB1986-12-10f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A071321-001DIAZEPAM5MGTABLET / ORALAB1986-12-10e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A071321-001DIAZEPAM5MGTABLET / ORALAB1986-12-10cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A071321-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A071321-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A071321-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A071321-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A071321-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A071321-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A071321-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A071321-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A071321-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A071321-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A071321-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A071321-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A071321-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A071321-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A071321-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A071321-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A071321-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A071321-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A071321-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A071321-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A071321-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A071321-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A071321-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A071321-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A071321-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A071321-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A071321-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A071321-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A071321-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A071321-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A071321-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A071321-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A071321-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A071321-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A071321-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A071321-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A071321-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A071321-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A071321-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A071321-001AB1cb3db0bc1861…

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 · 15 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DiazepamDIAZEPAMREMEDYREPACK INC.20e08b97-bb89-4129-a228-8ad9cf35a1d32026-07-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071321
application number: ANDA071321
DiazepamDIAZEPAMCoupler LLC5114ae6e-8cae-e96f-e063-6294a90a9e602026-05-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071321
application number: ANDA071321
DIAZEPAMDIAZEPAMDirect_Rx4b0c9c0a-4274-4d56-a7a4-bc497916469c2026-01-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071321
application number: ANDA071321
ndc (product): 61919-409
DiazepamDIAZEPAMPD-Rx Pharmaceuticals, Inc.2483426d-3782-432a-8b8d-86c06ef0de4a2025-10-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071321
application number: ANDA071321
ndc (product): 43063-970
DiazepamDIAZEPAMA-S Medication Solutionsb47dc708-e83b-4224-bdb5-c9b7abd35cfb2025-06-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071321
application number: ANDA071321
ndc (product): 50090-1913
DiazepamDIAZEPAMAsclemed USA, Inc.32e7bfa1-6060-4041-a0e5-249cacb84ebc2025-01-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071321
application number: ANDA071321
DiazepamDIAZEPAMNuCare Pharmaceuticals,Inc.823093aa-d0cd-53c9-e053-2a91aa0a52352024-06-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071321
application number: ANDA071321
ndc (product): 68071-4770
DiazepamDIAZEPAMNuCare Pharmaceuticals,Inc.8b3cc5c9-91bd-7467-e053-2a95a90a44b82024-06-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071321
application number: ANDA071321
ndc (product): 68071-4922
DiazepamDIAZEPAMBryant Ranch Prepack6abedac6-5133-47b2-a0e3-e239e0a2254b2024-05-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071321
application number: ANDA071321
DiazepamDIAZEPAMBryant Ranch Prepacke8e4d5f5-3b4c-4c0f-a818-9da86389473c2024-04-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071321
application number: ANDA071321
ndc (product): 63629-1523
DiazepamDIAZEPAMA-S Medication Solutionsaf9a7906-4dca-4c1f-b16b-9b666a86b3632024-02-18Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071321
application number: ANDA071321
ndc (product): 50090-2249
DiazepamDIAZEPAMTeva Pharmaceuticals USA, Inc.48aa32cb-047a-414a-822e-82a5f26d88172024-01-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071321
application number: ANDA071321
ndc (product): 0172-3926
DiazepamDIAZEPAMClinical Solutions Wholesale, LLC87b0fbb9-0c05-4ab0-8efe-7ffcae85b8682024-01-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071321
application number: ANDA071321
ndc (product): 58118-3926
DiazepamDIAZEPAMProficient Rx LPe7542d46-2586-4225-b07d-2633116bfa0a2022-04-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071321
application number: ANDA071321
ndc (product): 63187-173
DiazepamDIAZEPAMAphena Pharma Solutions - Tennessee, LLCbdb8feda-01c6-45bd-bd66-97196ccce70c2019-05-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071321
application number: ANDA071321

NDC Listings For This Application#

NDC listings for this application page 1 of 2 · 97 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0172-3926DiazepamDiazepamTeva Pharmaceuticals USA, Inc.ANDACurrent
0172-3926DiazepamDiazepamTeva Pharmaceuticals USA, Inc.ANDACurrent
0172-3926DiazepamDiazepamTeva Pharmaceuticals USA, Inc.ANDACurrent
0172-3926DiazepamDiazepamTeva Pharmaceuticals USA, Inc.ANDACurrent
0615-7799DiazepamDiazepamNCS HealthCare of KY, LLC dba Vangard LabsANDACurrent
0615-7799DiazepamDiazepamNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-7799DiazepamDiazepamNCS HealthCare of KY, LLC dba Vangard LabsANDACurrent
12634-529DIAZEPAMDIAZEPAMApotheca, Inc.ANDACurrent
21695-264DiazepamDiazepamRebel Distributors Corp.ANDACurrent
43063-970DiazepamDiazepamPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-970DiazepamDiazepamPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-970DiazepamDiazepamPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-970DiazepamDiazepamPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-970DiazepamDiazepamPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-970DiazepamDiazepamPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-970DiazepamDiazepamPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-970DiazepamDiazepamPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-970DiazepamDiazepamPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-970DiazepamDiazepamPD-Rx Pharmaceuticals, Inc.ANDACurrent
49999-018DiazepamDiazepamLake Erie Medical DBA QuaANDACurrent
49999-018DiazepamDiazepamQuality Care Products LLCANDACurrent
49999-018DiazepamDiazepamLake Erie Medical DBA Quality Care Products LLCANDACurrent
50090-1913DiazepamDiazepamA-S Medication SolutionsANDACurrent
50090-1913DiazepamDiazepamA-S Medication SolutionsANDACurrent
50090-1913DiazepamDiazepamA-S Medication SolutionsANDACurrent
50090-1913DiazepamDiazepamA-S Medication SolutionsANDACurrent
50090-2249DiazepamDiazepamA-S Medication SolutionsANDACurrent
50090-2249DiazepamDiazepamA-S Medication SolutionsANDACurrent
50090-4713DiazepamDiazepamA-S Medication SolutionsANDACurrent
50436-3592DiazepamDiazepamUnit Dose ServicesANDACurrent
53002-3340DiazepamDiazepamRPK Pharmaceuticals, Inc.ANDACurrent
53002-3340DiazepamDiazepamRPK Pharmaceuticals, Inc.ANDACurrent
53217-184DiazepamDiazepamAidarex Pharmaceuticals LLCANDACurrent
58118-3926DiazepamDiazepamClinical Solutions Wholesale, LLCANDACurrent
58118-3926DiazepamDiazepamClinical Solutions Wholesale, LLCANDACurrent
61919-409DIAZEPAMDIAZEPAMDIRECT RXANDACurrent
61919-409DIAZEPAMDIAZEPAMDirect_RxANDACurrent
61919-409DIAZEPAMDIAZEPAMDirect_RxANDACurrent
61919-409DIAZEPAMDIAZEPAMDirect_RxANDACurrent
61919-409DIAZEPAMDIAZEPAMDirect_RxANDACurrent
61919-409DIAZEPAMDIAZEPAMDirect_RxANDACurrent
61919-409DIAZEPAMDIAZEPAMDirect_RxANDACurrent
61919-409DIAZEPAMDIAZEPAMDirect_RxANDACurrent
61919-409DIAZEPAMDIAZEPAMDirect_RxANDACurrent
61919-409DIAZEPAMDIAZEPAMDirect_RxANDACurrent
61919-409DIAZEPAMDIAZEPAMDirect_RxANDACurrent
61919-409DIAZEPAMDIAZEPAMDirect_RxANDACurrent
61919-409DIAZEPAMDIAZEPAMDirect_RxANDACurrent
61919-409DIAZEPAMDIAZEPAMDirect_RxANDACurrent
63187-173DiazepamDiazepamProficient Rx LPANDACurrent
63187-173DiazepamDiazepamProficient Rx LPANDACurrent
63187-173DiazepamDiazepamProficient Rx LPANDACurrent
63187-173DiazepamDiazepamProficient Rx LPANDACurrent
63187-173DiazepamDiazepamProficient Rx LPANDACurrent
63629-1523DiazepamDiazepamBryant Ranch PrepackANDACurrent
63629-1523DiazepamDiazepamBryant Ranch PrepackANDACurrent
63629-1523DiazepamDiazepamBryant Ranch PrepackANDACurrent
63629-7851DiazepamDiazepamBryant Ranch PrepackANDACurrent
63629-8192DiazepamDiazepamBryant Ranch PrepackANDACurrent
63629-8192DiazepamDiazepamBryant Ranch PrepackANDACurrent
64725-3926DiazepamDiazepamTYA PharmaceuticalsANDACurrent
67046-943DiazepamDiazepamContract Pharmacy Services-PAANDACurrent
67296-0084DiazepamDiazepamRedPharm Drug, Inc.ANDACurrent
67296-0084DiazepamDiazepamRedPharm Drug, Inc.ANDACurrent
67296-0084DiazepamDiazepamRedPharm Drug, Inc.ANDACurrent
67296-0084DiazepamDiazepamRedPharm Drug, Inc.ANDACurrent
68071-4770DiazepamDiazepamNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4770DiazepamDiazepamNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4770DiazepamDiazepamNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4770DiazepamDiazepamNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4922DiazepamDiazepamNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4922DiazepamDiazepamNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4922DiazepamDiazepamNuCare Pharmaceuticals,Inc.ANDACurrent
68788-7452DiazepamDiazepamPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7452DiazepamDiazepamPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7452DiazepamDiazepamPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7452DiazepamDiazepamPreferred Pharmaceuticals, Inc.ANDACurrent
68788-9208DiazepamDiazepamPreferred Pharmaceuticals, Inc.ANDACurrent
68788-9208DiazepamDiazepamPreferred Pharmaceuticals, Inc.ANDACurrent
68788-9208DiazepamDiazepamPreferred Pharmaceuticals, Inc.ANDACurrent