Application 070325

Type
ANDA
Sponsor
MYLAN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DIAZEPAMDIAZEPAMTABLET;ORAL10MGNoNo
002DIAZEPAMDIAZEPAMTABLET;ORAL2MGNoNo
003DIAZEPAMDIAZEPAMTABLET;ORAL5MGNoNo

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A070325-001DIAZEPAMDIAZEPAM10MGTABLET / ORALAB1985-09-04
A070325-002DIAZEPAMDIAZEPAM2MGTABLET / ORALAB1985-09-04
A070325-003DIAZEPAMDIAZEPAM5MGTABLET / ORALAB1985-09-04

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A070325-001AB
A070325-002AB
A070325-003AB

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 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A070325-001DIAZEPAM10MGTABLET / ORALAB1985-09-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02A070325-002DIAZEPAM2MGTABLET / ORALAB1985-09-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02A070325-003DIAZEPAM5MGTABLET / ORALAB1985-09-04011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A070325-001DIAZEPAM10MGTABLET / ORALAB1985-09-0431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A070325-002DIAZEPAM2MGTABLET / ORALAB1985-09-0431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A070325-003DIAZEPAM5MGTABLET / ORALAB1985-09-0431067a03dcf5…
2025-08-23 18:47 UTC2025-08A070325-001DIAZEPAM10MGTABLET / ORALAB1985-09-046a471c1ec25d…
2025-08-23 18:47 UTC2025-08A070325-002DIAZEPAM2MGTABLET / ORALAB1985-09-046a471c1ec25d…
2025-08-23 18:47 UTC2025-08A070325-003DIAZEPAM5MGTABLET / ORALAB1985-09-046a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A070325-001DIAZEPAM10MGTABLET / ORALAB1985-09-04fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A070325-002DIAZEPAM2MGTABLET / ORALAB1985-09-04fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A070325-003DIAZEPAM5MGTABLET / ORALAB1985-09-04fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A070325-001DIAZEPAM10MGTABLET / ORALAB1985-09-04b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A070325-002DIAZEPAM2MGTABLET / ORALAB1985-09-04b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A070325-003DIAZEPAM5MGTABLET / ORALAB1985-09-04b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A070325-001DIAZEPAM10MGTABLET / ORALAB1985-09-0403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A070325-002DIAZEPAM2MGTABLET / ORALAB1985-09-0403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A070325-003DIAZEPAM5MGTABLET / ORALAB1985-09-0403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A070325-001DIAZEPAM10MGTABLET / ORALAB1985-09-042680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A070325-002DIAZEPAM2MGTABLET / ORALAB1985-09-042680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A070325-003DIAZEPAM5MGTABLET / ORALAB1985-09-042680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A070325-001DIAZEPAM10MGTABLET / ORALAB1985-09-045bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A070325-002DIAZEPAM2MGTABLET / ORALAB1985-09-045bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A070325-003DIAZEPAM5MGTABLET / ORALAB1985-09-045bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A070325-001DIAZEPAM10MGTABLET / ORALAB1985-09-04d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A070325-002DIAZEPAM2MGTABLET / ORALAB1985-09-04d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A070325-003DIAZEPAM5MGTABLET / ORALAB1985-09-04d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A070325-001DIAZEPAM10MGTABLET / ORALAB1985-09-04d06236e962d9…
2024-10-29 15:01 UTC2024-10A070325-002DIAZEPAM2MGTABLET / ORALAB1985-09-04d06236e962d9…
2024-10-29 15:01 UTC2024-10A070325-003DIAZEPAM5MGTABLET / ORALAB1985-09-04d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A070325-001DIAZEPAM10MGTABLET / ORALAB1985-09-0479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A070325-002DIAZEPAM2MGTABLET / ORALAB1985-09-0479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A070325-003DIAZEPAM5MGTABLET / ORALAB1985-09-0479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A070325-001DIAZEPAM10MGTABLET / ORALAB1985-09-04301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A070325-002DIAZEPAM2MGTABLET / ORALAB1985-09-04301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A070325-003DIAZEPAM5MGTABLET / ORALAB1985-09-04301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A070325-001DIAZEPAM10MGTABLET / ORALAB1985-09-041e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A070325-002DIAZEPAM2MGTABLET / ORALAB1985-09-041e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A070325-003DIAZEPAM5MGTABLET / ORALAB1985-09-041e350fbaab3a…
2024-05-31 18:47 UTC2024-05A070325-001DIAZEPAM10MGTABLET / ORALAB1985-09-048072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A070325-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A070325-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A070325-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A070325-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A070325-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A070325-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A070325-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A070325-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A070325-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A070325-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A070325-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A070325-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A070325-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A070325-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A070325-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A070325-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A070325-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A070325-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A070325-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A070325-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A070325-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A070325-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A070325-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A070325-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A070325-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A070325-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A070325-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A070325-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A070325-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A070325-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A070325-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A070325-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A070325-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A070325-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A070325-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A070325-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A070325-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A070325-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A070325-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A070325-001AB18072bd15b7f6…

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 · 16 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DiazepamDIAZEPAMUnit Dose Solutions, Inc.547c2ad4-113c-7771-e063-6394a90a20732026-06-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070325
application number: ANDA070325
DiazepamDIAZEPAMCardinal Health 107, LLCba953b22-f0cd-4be5-9e0e-178bded887272026-04-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070325
application number: ANDA070325
ndc (product): 55154-5554
ndc (product): 55154-5074
DiazepamDIAZEPAMPreferred Pharmaceuticals Inc.6dcbb5e9-1e8f-4069-9244-adb46356714d2026-04-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070325
application number: ANDA070325
DiazepamDIAZEPAMPreferred Pharmaceuticals Inc.7646785b-dabc-482d-bf42-06177f00aca22026-04-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070325
application number: ANDA070325
DiazepamDIAZEPAMSafecor Health, LLC8b51f4b3-a5e8-4400-b624-ac0c47630c862026-02-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070325
application number: ANDA070325
DiazepamDIAZEPAMDirect_Rx181cc7ac-5129-2200-e063-6394a90afd3a2026-01-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070325
application number: ANDA070325
DiazepamDIAZEPAMA-S Medication Solutions01f04ee4-fff9-499a-8213-984e163680842025-10-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070325
application number: ANDA070325
ndc (product): 50090-3390
DiazepamDIAZEPAMPD-Rx Pharmaceuticals, Inc.c2768add-5e01-4ff4-afa3-230380d59a1f2025-10-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070325
application number: ANDA070325
ndc (product): 55289-092
DiazepamDIAZEPAMMylan Institutional Inc.b326c66d-5762-4d16-933c-619fa2088ccd2025-07-18Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070325
application number: ANDA070325
ndc (product): 51079-285
ndc (product): 51079-284
ndc (product): 51079-286
DiazepamDIAZEPAMAdvanced Rx of Tennessee, LLC2d322c6a-7f7e-1cc4-e063-6294a90a8e2e2025-04-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070325
application number: ANDA070325
DiazepamDIAZEPAMBryant Ranch Prepack9424ce71-f04c-4d70-89de-b7858931c53d2024-08-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070325
application number: ANDA070325
DiazepamDIAZEPAMBryant Ranch Prepack632d7e96-d32c-45b8-86cf-f18ec2b354852024-08-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070325
application number: ANDA070325
DiazepamDIAZEPAMDirect_rx2047f721-6a05-c391-e063-6394a90a4ed72024-08-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070325
application number: ANDA070325
DiazepamDIAZEPAMClinical Solutions Wholesale, LLC8b4946b3-ae6c-4174-bbd8-0b8ed2c8fdf32024-01-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070325
application number: ANDA070325
ndc (product): 58118-4047
DiazepamDIAZEPAMBryant Ranch Prepackf2fc6f38-d627-4fb3-9be2-5e119ee7e1e12023-12-11Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070325
application number: ANDA070325
DiazepamDIAZEPAMMylan Pharmaceuticals Inc.c397a9da-862f-4f3f-8109-7d21691de53a2023-04-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070325
application number: ANDA070325
ndc (product): 0378-0477
ndc (product): 0378-0271
ndc (product): 0378-0345

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 49 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0378-0271DiazepamdiazepamMylan Pharmaceuticals Inc.ANDACurrent
0378-0271DiazepamdiazepamMylan Pharmaceuticals Inc.ANDACurrent
0378-0271DiazepamdiazepamMylan Pharmaceuticals Inc.ANDACurrent
0378-0271DiazepamdiazepamMylan Pharmaceuticals Inc.ANDACurrent
0378-0271DiazepamdiazepamMylan Pharmaceuticals Inc.ANDACurrent
0378-0345DiazepamdiazepamMylan Pharmaceuticals Inc.ANDACurrent
0378-0345DiazepamdiazepamMylan Pharmaceuticals Inc.ANDACurrent
0378-0345DiazepamdiazepamMylan Pharmaceuticals Inc.ANDACurrent
0378-0345DiazepamdiazepamMylan Pharmaceuticals Inc.ANDACurrent
0378-0345DiazepamdiazepamMylan Pharmaceuticals Inc.ANDACurrent
0378-0477DiazepamdiazepamMylan Pharmaceuticals Inc.ANDACurrent
0378-0477DiazepamdiazepamMylan Pharmaceuticals Inc.ANDACurrent
0378-0477DiazepamdiazepamMylan Pharmaceuticals Inc.ANDACurrent
0378-0477DiazepamdiazepamMylan Pharmaceuticals Inc.ANDACurrent
0378-0477DiazepamdiazepamMylan Pharmaceuticals Inc.ANDACurrent
0615-8049DiazepamdiazepamNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-8049DiazepamdiazepamNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
43063-718DiazepamdiazepamPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-718DiazepamdiazepamPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-718DiazepamdiazepamPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-718DiazepamdiazepamPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-718DiazepamdiazepamPD-Rx Pharmaceuticals, Inc.ANDACurrent
50090-1959DiazepamdiazepamA-S Medication SolutionsANDACurrent
50090-2063DiazepamdiazepamA-S Medication SolutionsANDACurrent
50090-3390DiazepamdiazepamA-S Medication SolutionsANDACurrent
50090-3390DiazepamdiazepamA-S Medication SolutionsANDACurrent
50090-4566DiazepamdiazepamA-S Medication SolutionsANDACurrent
51079-284DiazepamdiazepamMylan Institutional Inc.ANDACurrent
51079-284DiazepamdiazepamMylan Institutional Inc.ANDACurrent
51079-285DiazepamdiazepamMylan Institutional Inc.ANDACurrent
51079-285DiazepamdiazepamMylan Institutional Inc.ANDACurrent
51079-286DiazepamdiazepamMylan Institutional Inc.ANDACurrent
51079-286DiazepamdiazepamMylan Institutional Inc.ANDACurrent
55154-5074DiazepamdiazepamCardinal Health 107, LLCANDACurrent
55154-5074DiazepamdiazepamCardinal HealthANDACurrent
55154-5074DiazepamdiazepamCardinal HealthANDACurrent
55154-5074DiazepamdiazepamCardinal HealthANDACurrent
55154-5554DiazepamdiazepamCardinal Health 107, LLCANDACurrent
55154-5554DiazepamdiazepamCardinal HealthANDACurrent
55154-5554DiazepamdiazepamCardinal HealthANDACurrent
55154-5554DiazepamdiazepamCardinal HealthANDACurrent
55289-092DiazepamdiazepamPD-Rx Pharmaceuticals, InANDACurrent
55289-092DiazepamdiazepamPD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-092DiazepamdiazepamPD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-092DiazepamdiazepamPD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-092DiazepamdiazepamPD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-092DiazepamdiazepamPD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-092DiazepamdiazepamPD-Rx Pharmaceuticals, Inc.ANDACurrent
58118-4047DiazepamdiazepamClinical Solutions Wholesale, LLCANDACurrent