Application 091422

Type
ANDA
Sponsor
ACTAVIS ELIZABETH

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDEBUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDETABLET;SUBLINGUALEQ 2MG BASE;EQ 0.5MG BASENoNo
002BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDEBUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDETABLET;SUBLINGUALEQ 8MG BASE;EQ 2MG BASENoYes

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
A091422-001BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDEBUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDEEQ 2MG BASE;EQ 0.5MG BASETABLET / SUBLINGUALAB2013-02-22
A091422-002BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDEBUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDEEQ 8MG BASE;EQ 2MG BASETABLET / SUBLINGUALAB2013-02-22

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A091422-001AB
A091422-002AB

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 UTC2026-02A091422-001BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDEEQ 2MG BASE;EQ 0.5MG BASETABLET / SUBLINGUALAB2013-02-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091422-002BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDEEQ 8MG BASE;EQ 2MG BASETABLET / SUBLINGUALAB2013-02-22011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091422-001BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDEEQ 2MG BASE;EQ 0.5MG BASETABLET / SUBLINGUALAB2013-02-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091422-002BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDEEQ 8MG BASE;EQ 2MG BASETABLET / SUBLINGUALAB2013-02-2231067a03dcf5…
2025-08-23 18:47 UTC2025-08A091422-001BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDEEQ 2MG BASE;EQ 0.5MG BASETABLET / SUBLINGUALAB2013-02-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091422-002BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDEEQ 8MG BASE;EQ 2MG BASETABLET / SUBLINGUALAB2013-02-226a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091422-001BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDEEQ 2MG BASE;EQ 0.5MG BASETABLET / SUBLINGUALAB2013-02-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091422-002BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDEEQ 8MG BASE;EQ 2MG BASETABLET / SUBLINGUALAB2013-02-22fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091422-001BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDEEQ 2MG BASE;EQ 0.5MG BASETABLET / SUBLINGUALAB2013-02-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091422-002BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDEEQ 8MG BASE;EQ 2MG BASETABLET / SUBLINGUALAB2013-02-22b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091422-001BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDEEQ 2MG BASE;EQ 0.5MG BASETABLET / SUBLINGUALAB2013-02-2203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091422-002BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDEEQ 8MG BASE;EQ 2MG BASETABLET / SUBLINGUALAB2013-02-2203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091422-001BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDEEQ 2MG BASE;EQ 0.5MG BASETABLET / SUBLINGUALAB2013-02-222680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091422-002BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDEEQ 8MG BASE;EQ 2MG BASETABLET / SUBLINGUALAB2013-02-222680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091422-001BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDEEQ 2MG BASE;EQ 0.5MG BASETABLET / SUBLINGUALAB2013-02-225bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091422-002BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDEEQ 8MG BASE;EQ 2MG BASETABLET / SUBLINGUALAB2013-02-225bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091422-001BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDEEQ 2MG BASE;EQ 0.5MG BASETABLET / SUBLINGUALAB2013-02-22d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091422-002BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDEEQ 8MG BASE;EQ 2MG BASETABLET / SUBLINGUALAB2013-02-22d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A091422-001BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDEEQ 2MG BASE;EQ 0.5MG BASETABLET / SUBLINGUALAB2013-02-22d06236e962d9…
2024-10-29 15:01 UTC2024-10A091422-002BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDEEQ 8MG BASE;EQ 2MG BASETABLET / SUBLINGUALAB2013-02-22d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091422-001BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDEEQ 2MG BASE;EQ 0.5MG BASETABLET / SUBLINGUALAB2013-02-2279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091422-002BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDEEQ 8MG BASE;EQ 2MG BASETABLET / SUBLINGUALAB2013-02-2279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091422-001BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDEEQ 2MG BASE;EQ 0.5MG BASETABLET / SUBLINGUALAB2013-02-22301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091422-002BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDEEQ 8MG BASE;EQ 2MG BASETABLET / SUBLINGUALAB2013-02-22301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091422-001BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDEEQ 2MG BASE;EQ 0.5MG BASETABLET / SUBLINGUALAB2013-02-221e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091422-002BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDEEQ 8MG BASE;EQ 2MG BASETABLET / SUBLINGUALAB2013-02-221e350fbaab3a…
2024-05-31 18:47 UTC2024-05A091422-001BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDEEQ 2MG BASE;EQ 0.5MG BASETABLET / SUBLINGUALAB2013-02-228072bd15b7f6…
2024-05-31 18:47 UTC2024-05A091422-002BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDEEQ 8MG BASE;EQ 2MG BASETABLET / SUBLINGUALAB2013-02-228072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A091422-001BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDEEQ 2MG BASE;EQ 0.5MG BASETABLET / SUBLINGUALAB2013-02-225c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A091422-002BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDEEQ 8MG BASE;EQ 2MG BASETABLET / SUBLINGUALABRS2013-02-225c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A091422-001BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDEEQ 2MG BASE;EQ 0.5MG BASETABLET / SUBLINGUALAB2013-02-225d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A091422-002BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDEEQ 8MG BASE;EQ 2MG BASETABLET / SUBLINGUALABRS2013-02-225d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A091422-001BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDEEQ 2MG BASE;EQ 0.5MG BASETABLET / SUBLINGUALAB2013-02-224b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A091422-002BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDEEQ 8MG BASE;EQ 2MG BASETABLET / SUBLINGUALABRS2013-02-224b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A091422-001BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDEEQ 2MG BASE;EQ 0.5MG BASETABLET / SUBLINGUALAB2013-02-2274a2ff9319b5…
2019-12-13 00:20 UTC2019-12A091422-002BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDEEQ 8MG BASE;EQ 2MG BASETABLET / SUBLINGUALABRS2013-02-2274a2ff9319b5…
2022-03-09 01:35 UTC2022-03A091422-001BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDEEQ 2MG BASE;EQ 0.5MG BASETABLET / SUBLINGUALAB2013-02-22bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A091422-002BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDEEQ 8MG BASE;EQ 2MG BASETABLET / SUBLINGUALABRS2013-02-22bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A091422-001BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDEEQ 2MG BASE;EQ 0.5MG BASETABLET / SUBLINGUALAB2013-02-22782e0a99824c…
2021-12-28 21:50 UTC2021-12A091422-002BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDEEQ 8MG BASE;EQ 2MG BASETABLET / SUBLINGUALABRS2013-02-22782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A091422-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091422-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091422-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091422-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A091422-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091422-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091422-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091422-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091422-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091422-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091422-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091422-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091422-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091422-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091422-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091422-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091422-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091422-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A091422-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A091422-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091422-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091422-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091422-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091422-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091422-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091422-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A091422-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A091422-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A091422-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A091422-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A091422-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A091422-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A091422-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A091422-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A091422-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A091422-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A091422-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A091422-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A091422-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A091422-002AB1782e0a99824c…

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
Buprenorphine and NaloxoneBUPRENORPHINE AND NALOXONEActavis Pharma, Inc.6cccf229-9611-4b6f-8f1b-acc8ff1ed3f82026-02-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091422
application number: ANDA091422
ndc (product): 0228-3155
ndc (product): 0228-3154

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 26 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0228-3154Buprenorphine and NaloxoneBuprenorphine and NaloxoneActavis Pharma, Inc.ANDACurrent
0228-3154Buprenorphine and NaloxoneBuprenorphine and NaloxoneActavis Pharma, Inc.ANDACurrent
0228-3154Buprenorphine and NaloxoneBuprenorphine and NaloxoneActavis Pharma, Inc.ANDACurrent
0228-3154Buprenorphine and NaloxoneBuprenorphine and NaloxoneActavis Pharma, Inc.ANDACurrent
0228-3154Buprenorphine and NaloxoneBuprenorphine and NaloxoneActavis Pharma, Inc.ANDACurrent
0228-3154Buprenorphine and NaloxoneBuprenorphine and NaloxoneActavis Pharma, Inc.ANDACurrent
0228-3154Buprenorphine and NaloxoneBuprenorphine and NaloxoneActavis Pharma, Inc.ANDACurrent
0228-3154Buprenorphine and NaloxoneBuprenorphine and NaloxoneActavis Pharma, Inc.ANDACurrent
0228-3154Buprenorphine and NaloxoneBuprenorphine and NaloxoneActavis Pharma, Inc.ANDACurrent
0228-3154Buprenorphine and NaloxoneBuprenorphine and NaloxoneActavis Pharma, Inc.ANDACurrent
0228-3154Buprenorphine and NaloxoneBuprenorphine and NaloxoneActavis Pharma, Inc.ANDACurrent
0228-3154Buprenorphine and NaloxoneBuprenorphine and NaloxoneActavis Pharma, Inc.ANDACurrent
0228-3154Buprenorphine and NaloxoneBuprenorphine and NaloxoneActavis Pharma, Inc.ANDACurrent
0228-3155Buprenorphine and NaloxoneBuprenorphine and NaloxoneActavis Pharma, Inc.ANDACurrent
0228-3155Buprenorphine and NaloxoneBuprenorphine and NaloxoneActavis Pharma, Inc.ANDACurrent
0228-3155Buprenorphine and NaloxoneBuprenorphine and NaloxoneActavis Pharma, Inc.ANDACurrent
0228-3155Buprenorphine and NaloxoneBuprenorphine and NaloxoneActavis Pharma, Inc.ANDACurrent
0228-3155Buprenorphine and NaloxoneBuprenorphine and NaloxoneActavis Pharma, Inc.ANDACurrent
0228-3155Buprenorphine and NaloxoneBuprenorphine and NaloxoneActavis Pharma, Inc.ANDACurrent
0228-3155Buprenorphine and NaloxoneBuprenorphine and NaloxoneActavis Pharma, Inc.ANDACurrent
0228-3155Buprenorphine and NaloxoneBuprenorphine and NaloxoneActavis Pharma, Inc.ANDACurrent
0228-3155Buprenorphine and NaloxoneBuprenorphine and NaloxoneActavis Pharma, Inc.ANDACurrent
0228-3155Buprenorphine and NaloxoneBuprenorphine and NaloxoneActavis Pharma, Inc.ANDACurrent
0228-3155Buprenorphine and NaloxoneBuprenorphine and NaloxoneActavis Pharma, Inc.ANDACurrent
0228-3155Buprenorphine and NaloxoneBuprenorphine and NaloxoneActavis Pharma, Inc.ANDACurrent
0228-3155Buprenorphine and NaloxoneBuprenorphine and NaloxoneActavis Pharma, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
44556ORIG2015-07-02
9338SUPPL2014-05-29
9337ORIG2013-02-26