Application 071297

Type
ANDA
Sponsor
MYLAN PHARMS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDEAMITRIPTYLINE HYDROCHLORIDE; CHLORDIAZEPOXIDETABLET;ORALEQ 25MG BASE;10MGNoYes
002CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDEAMITRIPTYLINE HYDROCHLORIDE; CHLORDIAZEPOXIDETABLET;ORALEQ 12.5MG BASE;5MGNoNo

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
A071297-001CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDEAMITRIPTYLINE HYDROCHLORIDE; CHLORDIAZEPOXIDEEQ 25MG BASE;10MGTABLET / ORALRS1986-12-10
A071297-002CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDEAMITRIPTYLINE HYDROCHLORIDE; CHLORDIAZEPOXIDEEQ 12.5MG BASE;5MGTABLET / ORAL1986-12-10

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 UTC2026-02A071297-001CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDEEQ 25MG BASE;10MGTABLET / ORALRS1986-12-10011fe1cb6892…
2026-02-19 14:30 UTC2026-02A071297-002CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDEEQ 12.5MG BASE;5MGTABLET / ORAL1986-12-10011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A071297-001CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDEEQ 25MG BASE;10MGTABLET / ORALRS1986-12-1031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A071297-002CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDEEQ 12.5MG BASE;5MGTABLET / ORAL1986-12-1031067a03dcf5…
2025-08-23 18:47 UTC2025-08A071297-001CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDEEQ 25MG BASE;10MGTABLET / ORALRS1986-12-106a471c1ec25d…
2025-08-23 18:47 UTC2025-08A071297-002CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDEEQ 12.5MG BASE;5MGTABLET / ORAL1986-12-106a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A071297-001CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDEEQ 25MG BASE;10MGTABLET / ORALABRS1986-12-10fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A071297-002CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDEEQ 12.5MG BASE;5MGTABLET / ORALAB1986-12-10fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A071297-001CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDEEQ 25MG BASE;10MGTABLET / ORALABRS1986-12-10b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A071297-002CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDEEQ 12.5MG BASE;5MGTABLET / ORALAB1986-12-10b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A071297-001CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDEEQ 25MG BASE;10MGTABLET / ORALABRS1986-12-1003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A071297-002CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDEEQ 12.5MG BASE;5MGTABLET / ORALAB1986-12-1003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A071297-001CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDEEQ 25MG BASE;10MGTABLET / ORALABRS1986-12-102680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A071297-002CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDEEQ 12.5MG BASE;5MGTABLET / ORALAB1986-12-102680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A071297-001CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDEEQ 25MG BASE;10MGTABLET / ORALABRS1986-12-105bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A071297-002CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDEEQ 12.5MG BASE;5MGTABLET / ORALAB1986-12-105bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A071297-001CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDEEQ 25MG BASE;10MGTABLET / ORALABRS1986-12-10d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A071297-002CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDEEQ 12.5MG BASE;5MGTABLET / ORALAB1986-12-10d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A071297-001CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDEEQ 25MG BASE;10MGTABLET / ORALABRS1986-12-10d06236e962d9…
2024-10-29 15:01 UTC2024-10A071297-002CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDEEQ 12.5MG BASE;5MGTABLET / ORALAB1986-12-10d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A071297-001CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDEEQ 25MG BASE;10MGTABLET / ORALABRS1986-12-1079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A071297-002CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDEEQ 12.5MG BASE;5MGTABLET / ORALAB1986-12-1079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A071297-001CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDEEQ 25MG BASE;10MGTABLET / ORALABRS1986-12-10301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A071297-002CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDEEQ 12.5MG BASE;5MGTABLET / ORALAB1986-12-10301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A071297-001CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDEEQ 25MG BASE;10MGTABLET / ORALABRS1986-12-101e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A071297-002CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDEEQ 12.5MG BASE;5MGTABLET / ORALAB1986-12-101e350fbaab3a…
2024-05-31 18:47 UTC2024-05A071297-001CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDEEQ 25MG BASE;10MGTABLET / ORALABRS1986-12-108072bd15b7f6…
2024-05-31 18:47 UTC2024-05A071297-002CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDEEQ 12.5MG BASE;5MGTABLET / ORALAB1986-12-108072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A071297-001CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDEEQ 25MG BASE;10MGTABLET / ORALABRS1986-12-105c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A071297-002CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDEEQ 12.5MG BASE;5MGTABLET / ORALAB1986-12-105c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A071297-001CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDEEQ 25MG BASE;10MGTABLET / ORALABRS1986-12-105d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A071297-002CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDEEQ 12.5MG BASE;5MGTABLET / ORALAB1986-12-105d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A071297-001CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDEEQ 25MG BASE;10MGTABLET / ORALABRS1986-12-104b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A071297-002CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDEEQ 12.5MG BASE;5MGTABLET / ORALAB1986-12-104b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A071297-001CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDEEQ 25MG BASE;10MGTABLET / ORALRS1986-12-1074a2ff9319b5…
2019-12-13 00:20 UTC2019-12A071297-002CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDEEQ 12.5MG BASE;5MGTABLET / ORAL1986-12-1074a2ff9319b5…
2022-03-09 01:35 UTC2022-03A071297-001CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDEEQ 25MG BASE;10MGTABLET / ORALABRS1986-12-10bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A071297-002CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDEEQ 12.5MG BASE;5MGTABLET / ORALAB1986-12-10bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A071297-001CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDEEQ 25MG BASE;10MGTABLET / ORALRS1986-12-10782e0a99824c…
2021-12-28 21:50 UTC2021-12A071297-002CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDEEQ 12.5MG BASE;5MGTABLET / ORAL1986-12-10782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 56 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A071297-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A071297-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A071297-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A071297-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A071297-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A071297-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A071297-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A071297-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A071297-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A071297-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A071297-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A071297-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A071297-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A071297-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A071297-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A071297-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A071297-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A071297-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A071297-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A071297-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A071297-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A071297-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A071297-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A071297-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A071297-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A071297-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A071297-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A071297-002AB14b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A071297-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A071297-002AB1bb7c543d1eb4…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A071297-001AB16a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A071297-002AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A071297-001AB11c564ffb4f44…
2024-02-18 07:12 UTC2024-02A071297-002AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A071297-001AB1ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12A071297-002AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A071297-001AB1a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A071297-002AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A071297-001AB19b2671bbb829…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A071297-002AB19b2671bbb829…

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Chlordiazepoxide and Amitriptyline HydrochlorideCHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDEMylan Pharmaceuticals Inc.66a756f2-ac77-451c-a19a-08896d73b15c2026-03-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071297
application number: ANDA071297
ndc (product): 0378-0277
ndc (product): 0378-0211

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 20 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0378-0211Chlordiazepoxide and Amitriptyline Hydrochloridechlordiazepoxide and amitriptyline hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-0211Chlordiazepoxide and Amitriptyline Hydrochloridechlordiazepoxide and amitriptyline hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-0211Chlordiazepoxide and Amitriptyline Hydrochloridechlordiazepoxide and amitriptyline hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-0211Chlordiazepoxide and Amitriptyline Hydrochloridechlordiazepoxide and amitriptyline hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-0211Chlordiazepoxide and Amitriptyline Hydrochloridechlordiazepoxide and amitriptyline hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-0211Chlordiazepoxide and Amitriptyline Hydrochloridechlordiazepoxide and amitriptyline hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-0211Chlordiazepoxide and Amitriptyline Hydrochloridechlordiazepoxide and amitriptyline hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-0211Chlordiazepoxide and Amitriptyline Hydrochloridechlordiazepoxide and amitriptyline hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-0211Chlordiazepoxide and Amitriptyline Hydrochloridechlordiazepoxide and amitriptyline hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-0211Chlordiazepoxide and Amitriptyline Hydrochloridechlordiazepoxide and amitriptyline hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-0277Chlordiazepoxide and Amitriptyline Hydrochloridechlordiazepoxide and amitriptyline hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-0277Chlordiazepoxide and Amitriptyline Hydrochloridechlordiazepoxide and amitriptyline hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-0277Chlordiazepoxide and Amitriptyline Hydrochloridechlordiazepoxide and amitriptyline hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-0277Chlordiazepoxide and Amitriptyline Hydrochloridechlordiazepoxide and amitriptyline hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-0277Chlordiazepoxide and Amitriptyline Hydrochloridechlordiazepoxide and amitriptyline hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-0277Chlordiazepoxide and Amitriptyline Hydrochloridechlordiazepoxide and amitriptyline hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-0277Chlordiazepoxide and Amitriptyline Hydrochloridechlordiazepoxide and amitriptyline hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-0277Chlordiazepoxide and Amitriptyline Hydrochloridechlordiazepoxide and amitriptyline hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-0277Chlordiazepoxide and Amitriptyline Hydrochloridechlordiazepoxide and amitriptyline hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-0277Chlordiazepoxide and Amitriptyline Hydrochloridechlordiazepoxide and amitriptyline hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
18345SUPPL2014-09-05
39430SUPPL2014-07-30
23427SUPPL2014-07-30
18344SUPPL2014-07-30
30667SUPPL2014-07-24
8406SUPPL2014-07-24