Application 071322

Type
ANDA
Sponsor
IVAX SUB TEVA PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DIAZEPAMDIAZEPAMTABLET;ORAL10MGNoNo

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
A071322-001DIAZEPAMDIAZEPAM10MGTABLET / 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
A071322-001AB

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 UTC2026-02A071322-001DIAZEPAM10MGTABLET / ORALAB1986-12-10011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A071322-001DIAZEPAM10MGTABLET / ORALAB1986-12-1031067a03dcf5…
2025-08-23 18:47 UTC2025-08A071322-001DIAZEPAM10MGTABLET / ORALAB1986-12-106a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A071322-001DIAZEPAM10MGTABLET / ORALAB1986-12-10fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A071322-001DIAZEPAM10MGTABLET / ORALAB1986-12-10b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A071322-001DIAZEPAM10MGTABLET / ORALAB1986-12-1003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A071322-001DIAZEPAM10MGTABLET / ORALAB1986-12-102680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A071322-001DIAZEPAM10MGTABLET / ORALAB1986-12-105bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A071322-001DIAZEPAM10MGTABLET / ORALAB1986-12-10d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A071322-001DIAZEPAM10MGTABLET / ORALAB1986-12-10d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A071322-001DIAZEPAM10MGTABLET / ORALAB1986-12-1079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A071322-001DIAZEPAM10MGTABLET / ORALAB1986-12-10301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A071322-001DIAZEPAM10MGTABLET / ORALAB1986-12-101e350fbaab3a…
2024-05-31 18:47 UTC2024-05A071322-001DIAZEPAM10MGTABLET / ORALAB1986-12-108072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A071322-001DIAZEPAM10MGTABLET / ORALAB1986-12-105c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A071322-001DIAZEPAM10MGTABLET / ORALAB1986-12-105d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A071322-001DIAZEPAM10MGTABLET / ORALAB1986-12-104b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A071322-001DIAZEPAM10MGTABLET / ORALAB1986-12-1074a2ff9319b5…
2022-03-09 01:35 UTC2022-03A071322-001DIAZEPAM10MGTABLET / ORALAB1986-12-10bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A071322-001DIAZEPAM10MGTABLET / ORALAB1986-12-10782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A071322-001DIAZEPAM10MGTABLET / ORALAB1986-12-1087673890dc5c…
2021-03-12 10:30 UTC2021-03A071322-001DIAZEPAM10MGTABLET / ORALAB1986-12-105aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A071322-001DIAZEPAM10MGTABLET / ORALAB1986-12-108869cabd3fbd…
2020-11-12 02:37 UTC2020-11A071322-001DIAZEPAM10MGTABLET / ORALAB1986-12-10c0c555d07b60…
2019-12-14 00:12 UTC2019-12A071322-001DIAZEPAM10MGTABLET / ORALAB1986-12-103f01610625f2…
2019-09-15 20:21 UTC2019-09A071322-001DIAZEPAM10MGTABLET / ORALAB1986-12-10b00525d2431f…
2019-07-19 19:46 UTC2019-07A071322-001DIAZEPAM10MGTABLET / ORALAB1986-12-10ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A071322-001DIAZEPAM10MGTABLET / ORALAB1986-12-106a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A071322-001DIAZEPAM10MGTABLET / ORALAB1986-12-101c564ffb4f44…
2023-12-20 04:57 UTC2023-12A071322-001DIAZEPAM10MGTABLET / ORALAB1986-12-10ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A071322-001DIAZEPAM10MGTABLET / ORALAB1986-12-10a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A071322-001DIAZEPAM10MGTABLET / ORALAB1986-12-109b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A071322-001DIAZEPAM10MGTABLET / ORALAB1986-12-10a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A071322-001DIAZEPAM10MGTABLET / ORALAB1986-12-103f0d92c62455…
2023-05-13 08:27 UTC2023-05A071322-001DIAZEPAM10MGTABLET / ORALAB1986-12-10053a50430f4f…
2023-01-26 05:58 UTC2023-01A071322-001DIAZEPAM10MGTABLET / ORALAB1986-12-103bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A071322-001DIAZEPAM10MGTABLET / ORALAB1986-12-103a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A071322-001DIAZEPAM10MGTABLET / ORALAB1986-12-10f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A071322-001DIAZEPAM10MGTABLET / ORALAB1986-12-10e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A071322-001DIAZEPAM10MGTABLET / 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 UTC2026-02A071322-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A071322-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A071322-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A071322-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A071322-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A071322-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A071322-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A071322-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A071322-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A071322-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A071322-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A071322-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A071322-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A071322-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A071322-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A071322-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A071322-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A071322-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A071322-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A071322-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A071322-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A071322-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A071322-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A071322-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A071322-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A071322-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A071322-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A071322-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A071322-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A071322-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A071322-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A071322-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A071322-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A071322-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A071322-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A071322-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A071322-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A071322-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A071322-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A071322-001AB1cb3db0bc1861…

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 · 13 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DiazepamDIAZEPAMREMEDYREPACK INC.5ebef149-1858-4199-aaed-7b9341fae63d2026-06-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071322
application number: ANDA071322
ndc (product): 70518-0162
DiazepamDIAZEPAMCoupler LLC5111654f-a026-71b2-e063-6294a90ab49b2026-05-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071322
application number: ANDA071322
DiazepamDIAZEPAMREMEDYREPACK INC.d7a4b3c7-7021-4764-8c21-49e4bc6f60582026-03-12Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071322
application number: ANDA071322
ndc (product): 70518-0014
DIAZEPAMDIAZEPAMDirect_Rx4b0c9c0a-4274-4d56-a7a4-bc497916469c2026-01-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071322
application number: ANDA071322
ndc (product): 61919-906
DiazepamDIAZEPAMPD-Rx Pharmaceuticals, Inc.84cecab3-d0e6-436b-996b-0b598e9723082025-10-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071322
application number: ANDA071322
ndc (product): 43063-987
DiazepamDIAZEPAMA-S Medication Solutionsb47dc708-e83b-4224-bdb5-c9b7abd35cfb2025-06-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071322
application number: ANDA071322
ndc (product): 50090-1726
DiazepamDIAZEPAMAsclemed USA, Inc.32e7bfa1-6060-4041-a0e5-249cacb84ebc2025-01-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071322
application number: ANDA071322
DiazepamDIAZEPAMAdvanced Rx Pharmacy of Tennessee, LLCb7002d26-3856-4c2f-e053-2995a90aea602024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071322
application number: ANDA071322
ndc (product): 80425-0120
DiazepamDIAZEPAMNuCare Pharmaceuticals,Inc.859461ea-5861-8185-e053-2991aa0a954a2024-06-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071322
application number: ANDA071322
ndc (product): 68071-4829
DiazepamDIAZEPAMBryant Ranch Prepack078bbb41-7e3a-48db-87f0-ec6a6ec0194e2024-04-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071322
application number: ANDA071322
ndc (product): 71335-0444
DiazepamDIAZEPAMTeva Pharmaceuticals USA, Inc.48aa32cb-047a-414a-822e-82a5f26d88172024-01-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071322
application number: ANDA071322
ndc (product): 0172-3927
DiazepamDIAZEPAMAphena Pharma Solutions - Tennessee, LLC9cf031ae-d59b-430d-9b15-415ae2e49c982022-09-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071322
application number: ANDA071322
ndc (product): 71610-424
DiazepamDIAZEPAMProficient Rx LPf8d26f65-a015-4bfc-b1fa-8595d72af48c2022-08-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071322
application number: ANDA071322
ndc (product): 63187-544

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 68 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0172-3927DiazepamDiazepamTeva Pharmaceuticals USA, Inc.ANDACurrent
0172-3927DiazepamDiazepamTeva Pharmaceuticals USA, Inc.ANDACurrent
0172-3927DiazepamDiazepamTeva Pharmaceuticals USA, Inc.ANDACurrent
0172-3927DiazepamDiazepamTeva Pharmaceuticals USA, Inc.ANDACurrent
0615-7800DiazepamDiazepamNCS HealthCare of KY, LLC dba Vangard LabsANDACurrent
0615-7800DiazepamDiazepamNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
21695-265DiazepamDiazepamRebel Distributors Corp.ANDACurrent
35356-812DiazepamDiazepamLake Erie Medical DBA Quality Care Products LLCANDACurrent
35356-812DiazepamDiazepamQuality Care Products LLCANDACurrent
35356-812DiazepamDiazepamLake Erie Medical DBA Quality Care Products LLCANDACurrent
43063-987DiazepamDiazepamPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-987DiazepamDiazepamPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-987DiazepamDiazepamPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-987DiazepamDiazepamPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-987DiazepamDiazepamPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-987DiazepamDiazepamPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-987DiazepamDiazepamPD-Rx Pharmaceuticals, Inc.ANDACurrent
50090-1726DiazepamDiazepamA-S Medication SolutionsANDACurrent
50090-1726DiazepamDiazepamA-S Medication SolutionsANDACurrent
53217-185DiazepamDiazepamAidarex Pharmaceuticals LLCANDACurrent
58118-3927DiazepamDiazepamClinical Solutions Wholesale, LLCANDACurrent
60760-927DiazepamDiazepamSt Mary's Medical Park PharmacyANDACurrent
61919-906DIAZEPAMDIAZEPAMDirect_RxANDACurrent
61919-906DIAZEPAMDIAZEPAMDirect_RxANDACurrent
61919-906DIAZEPAMDIAZEPAMDirect_RxANDACurrent
63187-544DiazepamDiazepamProficient Rx LPANDACurrent
63187-544DiazepamDiazepamProficient Rx LPANDACurrent
63187-544DiazepamDiazepamProficient Rx LPANDACurrent
63629-7328DiazepamDiazepamBryant Ranch PrepackANDACurrent
67046-944DiazepamDiazepamContract Pharmacy Services-PAANDACurrent
68071-4829DiazepamDiazepamNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4829DiazepamDiazepamNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4899DiazepamDiazepamNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4899DiazepamDiazepamNuCare Pharmaceuticals,Inc.ANDACurrent
68788-9207DiazepamDiazepamPreferred Pharmaceuticals, Inc.ANDACurrent
68788-9207DiazepamDiazepamPreferred Pharmaceuticals, Inc.ANDACurrent
68788-9207DiazepamDiazepamPreferred Pharmaceuticals, Inc.ANDACurrent
68788-9207DiazepamDiazepamPreferred Pharmaceuticals, Inc.ANDACurrent
68788-9207DiazepamDiazepamPreferred Pharmaceuticals, Inc.ANDACurrent
68788-9207DiazepamDiazepamPreferred Pharmaceuticals, Inc.ANDACurrent
70518-0014DiazepamDiazepamREMEDYREPACK INC.ANDACurrent
70518-0014DiazepamDiazepamREMEDYREPACK INC.ANDACurrent
70518-0014DiazepamDiazepamREMEDYREPACK INC.ANDACurrent
70518-0014DiazepamDiazepamREMEDYREPACK INC.ANDACurrent
70518-0014DiazepamDiazepamREMEDYREPACK INC.ANDACurrent
70518-0014DiazepamDiazepamREMEDYREPACK INC.ANDACurrent
70518-0014DiazepamDiazepamREMEDYREPACK INC.ANDACurrent
70518-0014DiazepamDiazepamREMEDYREPACK INC.ANDACurrent
70518-0162DiazepamDiazepamREMEDYREPACK INC.ANDACurrent
70518-0162DiazepamDiazepamREMEDYREPACK INC.ANDACurrent
70518-0162DiazepamDiazepamREMEDYREPACK INC.ANDACurrent
70518-0162DiazepamDiazepamREMEDYREPACK INC.ANDACurrent
70518-0162DiazepamDiazepamREMEDYREPACK INC.ANDACurrent
70518-0162DiazepamDiazepamREMEDYREPACK INC.ANDACurrent
70518-0162DiazepamDiazepamREMEDYREPACK INC.ANDACurrent
70518-0162DiazepamDiazepamREMEDYREPACK INC.ANDACurrent
71335-0444DiazepamDiazepamBryant Ranch PrepackANDACurrent
71335-0444DiazepamDiazepamBryant Ranch PrepackANDACurrent
71335-0444DiazepamDiazepamBryant Ranch PrepackANDACurrent
71335-0444DiazepamDiazepamBryant Ranch PrepackANDACurrent
71610-424DiazepamDiazepamAphena Pharma Solutions - Tennessee, LLCANDACurrent
71610-424DiazepamDiazepamAphena Pharma Solutions - Tennessee, LLCANDACurrent
71610-424DiazepamDiazepamAphena Pharma Solutions - Tennessee, LLCANDACurrent
71610-424DiazepamDiazepamAphena Pharma Solutions - Tennessee, LLCANDACurrent
80425-0120ValiumDiazepam 10mgAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0120DiazepamDiazepamAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0120DiazepamDiazepamAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0120DiazepamDiazepamAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent