FDA.reportPublic FDA data

Application 203136

Type
ANDA
Sponsor
AMNEAL PHARMS

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 BASENoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A203136-001BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDEBUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDEEQ 2MG BASE;EQ 0.5MG BASETABLET / SUBLINGUALAB2013-02-22
A203136-002BUPRENORPHINE 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
A203136-001AB
A203136-002AB

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 · 86 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A203136-001BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDEEQ 2MG BASE;EQ 0.5MG BASETABLET / SUBLINGUALAB2013-02-2284e616aacf4f…
2026-09-14 22:38:342026-08A203136-002BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDEEQ 8MG BASE;EQ 2MG BASETABLET / SUBLINGUALAB2013-02-2284e616aacf4f…
2026-08-18 06:07:402026-07A203136-001BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDEEQ 2MG BASE;EQ 0.5MG BASETABLET / SUBLINGUALAB2013-02-22caaa826d4ba7…
2026-08-18 06:07:402026-07A203136-002BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDEEQ 8MG BASE;EQ 2MG BASETABLET / SUBLINGUALAB2013-02-22caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A203136-001BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDEEQ 2MG BASE;EQ 0.5MG BASETABLET / SUBLINGUALAB2013-02-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203136-002BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDEEQ 8MG BASE;EQ 2MG BASETABLET / SUBLINGUALAB2013-02-22011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203136-001BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDEEQ 2MG BASE;EQ 0.5MG BASETABLET / SUBLINGUALAB2013-02-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203136-002BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDEEQ 8MG BASE;EQ 2MG BASETABLET / SUBLINGUALAB2013-02-2231067a03dcf5…
2025-08-23 18:47 UTC2025-08A203136-001BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDEEQ 2MG BASE;EQ 0.5MG BASETABLET / SUBLINGUALAB2013-02-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203136-002BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDEEQ 8MG BASE;EQ 2MG BASETABLET / SUBLINGUALAB2013-02-226a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203136-001BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDEEQ 2MG BASE;EQ 0.5MG BASETABLET / SUBLINGUALAB2013-02-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203136-002BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDEEQ 8MG BASE;EQ 2MG BASETABLET / SUBLINGUALAB2013-02-22fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203136-001BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDEEQ 2MG BASE;EQ 0.5MG BASETABLET / SUBLINGUALAB2013-02-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203136-002BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDEEQ 8MG BASE;EQ 2MG BASETABLET / SUBLINGUALAB2013-02-22b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203136-001BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDEEQ 2MG BASE;EQ 0.5MG BASETABLET / SUBLINGUALAB2013-02-2203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203136-002BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDEEQ 8MG BASE;EQ 2MG BASETABLET / SUBLINGUALAB2013-02-2203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203136-001BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDEEQ 2MG BASE;EQ 0.5MG BASETABLET / SUBLINGUALAB2013-02-222680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203136-002BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDEEQ 8MG BASE;EQ 2MG BASETABLET / SUBLINGUALAB2013-02-222680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203136-001BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDEEQ 2MG BASE;EQ 0.5MG BASETABLET / SUBLINGUALAB2013-02-225bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203136-002BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDEEQ 8MG BASE;EQ 2MG BASETABLET / SUBLINGUALAB2013-02-225bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203136-001BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDEEQ 2MG BASE;EQ 0.5MG BASETABLET / SUBLINGUALAB2013-02-22d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203136-002BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDEEQ 8MG BASE;EQ 2MG BASETABLET / SUBLINGUALAB2013-02-22d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A203136-001BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDEEQ 2MG BASE;EQ 0.5MG BASETABLET / SUBLINGUALAB2013-02-22d06236e962d9…
2024-10-29 15:01 UTC2024-10A203136-002BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDEEQ 8MG BASE;EQ 2MG BASETABLET / SUBLINGUALAB2013-02-22d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203136-001BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDEEQ 2MG BASE;EQ 0.5MG BASETABLET / SUBLINGUALAB2013-02-2279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203136-002BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDEEQ 8MG BASE;EQ 2MG BASETABLET / SUBLINGUALAB2013-02-2279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203136-001BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDEEQ 2MG BASE;EQ 0.5MG BASETABLET / SUBLINGUALAB2013-02-22301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203136-002BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDEEQ 8MG BASE;EQ 2MG BASETABLET / SUBLINGUALAB2013-02-22301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203136-001BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDEEQ 2MG BASE;EQ 0.5MG BASETABLET / SUBLINGUALAB2013-02-221e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203136-002BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDEEQ 8MG BASE;EQ 2MG BASETABLET / SUBLINGUALAB2013-02-221e350fbaab3a…
2024-05-31 18:47 UTC2024-05A203136-001BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDEEQ 2MG BASE;EQ 0.5MG BASETABLET / SUBLINGUALAB2013-02-228072bd15b7f6…
2024-05-31 18:47 UTC2024-05A203136-002BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDEEQ 8MG BASE;EQ 2MG BASETABLET / SUBLINGUALAB2013-02-228072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203136-001BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDEEQ 2MG BASE;EQ 0.5MG BASETABLET / SUBLINGUALAB2013-02-225c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203136-002BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDEEQ 8MG BASE;EQ 2MG BASETABLET / SUBLINGUALAB2013-02-225c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A203136-001BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDEEQ 2MG BASE;EQ 0.5MG BASETABLET / SUBLINGUALAB2013-02-225d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A203136-002BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDEEQ 8MG BASE;EQ 2MG BASETABLET / SUBLINGUALAB2013-02-225d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A203136-001BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDEEQ 2MG BASE;EQ 0.5MG BASETABLET / SUBLINGUALAB2013-02-224b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A203136-002BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDEEQ 8MG BASE;EQ 2MG BASETABLET / SUBLINGUALAB2013-02-224b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A203136-001BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDEEQ 2MG BASE;EQ 0.5MG BASETABLET / SUBLINGUALAB2013-02-2274a2ff9319b5…
2019-12-13 00:20 UTC2019-12A203136-002BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDEEQ 8MG BASE;EQ 2MG BASETABLET / SUBLINGUALAB2013-02-2274a2ff9319b5…

Observed Orange Book normalized TE history#

Normalized TE history page 3 of 3 · 86 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2022-09-29 23:25 UTC2022-09A203136-001AB1e64feba35796…
2022-09-29 23:25 UTC2022-09A203136-002AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A203136-001AB1cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A203136-002AB1cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A203136-001AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A203136-002AB1a50c72e98297…

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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Buprenorphine HCl and Naloxone HClBUPRENORPHINE AND NALOXONEBryant Ranch Prepacke82e2d74-33a8-4894-82f6-788fc0f9feec2026-06-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203136
application number: ANDA203136
ndc (product): 71335-1514
Buprenorphine HCl and Naloxone HClBUPRENORPHINE AND NALOXONEBryant Ranch Prepack2aaad1a7-a0fd-4dd5-bb53-03afad8f10b92026-04-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203136
application number: ANDA203136
ndc (product): 63629-7269
Buprenorphine HCl and Naloxone HClBUPRENORPHINE AND NALOXONEAmneal Pharmaceuticals LLC17b63f10-c9df-44be-80fa-6f1c305583b82026-02-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203136
application number: ANDA203136
ndc (product): 65162-416
ndc (product): 65162-415
Buprenorphine HCl and Naloxone HClBUPRENORPHINE AND NALOXONEAvPAKb955054b-b37d-4079-4fed-5939b763ecb42026-01-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203136
application number: ANDA203136
ndc (product): 50268-145
ndc (product): 50268-144

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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
0406-1923Buprenorphine HCl and Naloxone HClBuprenorphine and NaloxoneMallinckrodt, Inc.ANDACurrent
0406-1923Buprenorphine HCl and Naloxone HClBuprenorphine and NaloxoneSpecGx LLCANDACurrent
0406-1923Buprenorphine HCl and Naloxone HClBuprenorphine and NaloxoneSpecGx LLCANDACurrent
0406-1924Buprenorphine HCl and Naloxone HClBuprenorphine and NaloxoneMallinckrodt, Inc.ANDACurrent
0406-1924Buprenorphine HCl and Naloxone HClBuprenorphine and NaloxoneSpecGx LLCANDACurrent
0406-1924Buprenorphine HCl and Naloxone HClBuprenorphine and NaloxoneSpecGx LLCANDACurrent
42291-174Buprenorphine HCl and Naloxone HClBuprenorphine and NaloxoneAvKARE, Inc.ANDACurrent
42291-174Buprenorphine HCl and Naloxone HClBuprenorphine and NaloxoneAvKARE, Inc.ANDACurrent
42291-175Buprenorphine HCl and Naloxone HClBuprenorphine and NaloxoneAvKARE, Inc.ANDACurrent
42291-175Buprenorphine HCl and Naloxone HClBuprenorphine and NaloxoneAvKARE, Inc.ANDACurrent
42291-175Buprenorphine HCl and Naloxone HClBuprenorphine and NaloxoneAvKARE, Inc.ANDACurrent
50268-144Buprenorphine HCl and Naloxone HClBuprenorphine and NaloxoneAvPAKANDACurrent
50268-144Buprenorphine HCl and Naloxone HClBuprenorphine and NaloxoneAvPAKANDACurrent
50268-144Buprenorphine HCl and Naloxone HClBuprenorphine and NaloxoneAvPAKANDACurrent
50268-144Buprenorphine HCl and Naloxone HClBuprenorphine and NaloxoneAvPAKANDACurrent
50268-145Buprenorphine HCl and Naloxone HClBuprenorphine and NaloxoneAvPAKANDACurrent
50268-145Buprenorphine HCl and Naloxone HClBuprenorphine and NaloxoneAvPAKANDACurrent
50268-145Buprenorphine HCl and Naloxone HClBuprenorphine and NaloxoneAvPAKANDACurrent
50268-145Buprenorphine HCl and Naloxone HClBuprenorphine and NaloxoneAvPAKANDACurrent
63629-7269Buprenorphine HCl and Naloxone HClBuprenorphine and NaloxoneBryant Ranch PrepackANDACurrent
63629-7269Buprenorphine HCl and Naloxone HClBuprenorphine and NaloxoneBryant Ranch PrepackANDACurrent
65162-415Buprenorphine HCl and Naloxone HClBuprenorphine and NaloxoneAmneal Pharmaceuticals LLCANDACurrent
65162-415Buprenorphine HCl and Naloxone HClBuprenorphine and NaloxoneAmneal Pharmaceuticals LLCANDACurrent
65162-415Buprenorphine HCl and Naloxone HClBuprenorphine and NaloxoneAmneal Pharmaceuticals LLCANDACurrent
65162-415Buprenorphine HCl and Naloxone HClBuprenorphine and NaloxoneAmneal Pharmaceuticals LLCANDACurrent
65162-415Buprenorphine HCl and Naloxone HClBuprenorphine and NaloxoneAmneal Pharmaceuticals LLCANDACurrent
65162-415Buprenorphine HCl and Naloxone HClBuprenorphine and NaloxoneAmneal Pharmaceuticals LLCANDACurrent
65162-415Buprenorphine HCl and Naloxone HClBuprenorphine and NaloxoneAmneal Pharmaceuticals LLCANDACurrent
65162-415Buprenorphine HCl and Naloxone HClBuprenorphine and NaloxoneAmneal Pharmaceuticals LLCANDACurrent
65162-416Buprenorphine HCl and Naloxone HClBuprenorphine and NaloxoneAmneal Pharmaceuticals LLCANDACurrent
65162-416Buprenorphine HCl and Naloxone HClBuprenorphine and NaloxoneAmneal Pharmaceuticals LLCANDACurrent
65162-416Buprenorphine HCl and Naloxone HClBuprenorphine and NaloxoneAmneal Pharmaceuticals LLCANDACurrent
65162-416Buprenorphine HCl and Naloxone HClBuprenorphine and NaloxoneAmneal Pharmaceuticals LLCANDACurrent
65162-416Buprenorphine HCl and Naloxone HClBuprenorphine and NaloxoneAmneal Pharmaceuticals LLCANDACurrent
65162-416Buprenorphine HCl and Naloxone HClBuprenorphine and NaloxoneAmneal Pharmaceuticals LLCANDACurrent
65162-416Buprenorphine HCl and Naloxone HClBuprenorphine and NaloxoneAmneal Pharmaceuticals LLCANDACurrent
65162-416Buprenorphine HCl and Naloxone HClBuprenorphine and NaloxoneAmneal Pharmaceuticals LLCANDACurrent
70518-1007Buprenorphine HCl and Naloxone HClBuprenorphine and NaloxoneREMEDYREPACK INC.ANDACurrent
70518-1007Buprenorphine HCl and Naloxone HClBuprenorphine and NaloxoneREMEDYREPACK INC.ANDACurrent
70518-1007Buprenorphine HCl and Naloxone HClBuprenorphine and NaloxoneREMEDYREPACK INC.ANDACurrent
70518-1007Buprenorphine HCl and Naloxone HClBuprenorphine and NaloxoneREMEDYREPACK INC.ANDACurrent
70518-1007Buprenorphine HCl and Naloxone HClBuprenorphine and NaloxoneREMEDYREPACK INC.ANDACurrent
70518-1007Buprenorphine HCl and Naloxone HClBuprenorphine and NaloxoneREMEDYREPACK INC.ANDACurrent
70518-1007Buprenorphine HCl and Naloxone HClBuprenorphine and NaloxoneREMEDYREPACK INC.ANDACurrent
70518-1684Buprenorphine HCl and Naloxone HClBuprenorphine and NaloxoneREMEDYREPACK INC.ANDACurrent
70518-1684Buprenorphine HCl and Naloxone HClBuprenorphine and NaloxoneREMEDYREPACK INC.ANDACurrent
71335-1514Buprenorphine HCl and Naloxone HClBuprenorphine and NaloxoneBryant Ranch PrepackANDACurrent
71335-1514Buprenorphine HCl and Naloxone HClBuprenorphine and NaloxoneBryant Ranch PrepackANDACurrent
71335-1514Buprenorphine HCl and Naloxone HClBuprenorphine and NaloxoneBryant Ranch PrepackANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
44587ORIG2015-07-02
10167SUPPL2014-05-29
32381ORIG2013-02-26