FDA.reportPublic FDA data

Application 204431

Type
ANDA
Sponsor
ETHYPHARM USA CORP

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 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
A204431-001BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDEBUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDEEQ 2MG BASE;EQ 0.5MG BASETABLET / SUBLINGUALAB2015-10-16
A204431-002BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDEBUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDEEQ 8MG BASE;EQ 2MG BASETABLET / SUBLINGUALAB2015-10-16

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A204431-001AB
A204431-002AB

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A204431-001BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDEEQ 2MG BASE;EQ 0.5MG BASETABLET / SUBLINGUALAB2015-10-16a50c72e98297…
2026-08-01 22:54:322026-06A204431-002BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDEEQ 8MG BASE;EQ 2MG BASETABLET / SUBLINGUALAB2015-10-16a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A204431-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A204431-002AB1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Buprenorphine and NaloxoneBUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDEPAI Holdings, LLC dba Pharmaceutical Associates, Inc. and dba PAI Pharmad5b011ef-f1be-47f2-8f8b-07553f36193c2026-02-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204431
application number: ANDA204431

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 35 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50383-287Buprenorphine and Naloxonebuprenorphine hydrochloride and naloxone hydrochlorideHi-Tech Pharmacal Co. Inc.ANDACurrent
50383-287Buprenorphine and Naloxonebuprenorphine hydrochloride and naloxone hydrochlorideHi-Tech Pharmacal Co. Inc.ANDACurrent
50383-287Buprenorphine and Naloxonebuprenorphine hydrochloride and naloxone hydrochlorideAkorn Operating Company LLC (dba Akorn)ANDACurrent
50383-287Buprenorphine and Naloxonebuprenorphine hydrochloride and naloxone hydrochlorideHi-Tech Pharmacal Co. Inc.ANDACurrent
50383-287Buprenorphine and Naloxonebuprenorphine hydrochloride and naloxone hydrochlorideHi-Tech Pharmacal Co. Inc.ANDACurrent
50383-287Buprenorphine and Naloxonebuprenorphine hydrochloride and naloxone hydrochlorideHi-Tech Pharmacal Co. Inc.ANDACurrent
50383-287Buprenorphine and Naloxonebuprenorphine hydrochloride and naloxone hydrochlorideHi-Tech Pharmacal Co. IncANDACurrent
50383-294Buprenorphine and Naloxonebuprenorphine hydrochloride and naloxone hydrochlorideHi-Tech Pharmacal Co. Inc.ANDACurrent
50383-294Buprenorphine and Naloxonebuprenorphine hydrochloride and naloxone hydrochlorideHi-Tech Pharmacal Co. Inc.ANDACurrent
50383-294Buprenorphine and Naloxonebuprenorphine hydrochloride and naloxone hydrochlorideAkorn Operating Company LLC (dba Akorn)ANDACurrent
50383-294Buprenorphine and Naloxonebuprenorphine hydrochloride and naloxone hydrochlorideHi-Tech Pharmacal Co. Inc.ANDACurrent
50383-294Buprenorphine and Naloxonebuprenorphine hydrochloride and naloxone hydrochlorideHi-Tech Pharmacal Co. Inc.ANDACurrent
50383-294Buprenorphine and Naloxonebuprenorphine hydrochloride and naloxone hydrochlorideHi-Tech Pharmacal Co. Inc.ANDACurrent
50383-294Buprenorphine and Naloxonebuprenorphine hydrochloride and naloxone hydrochlorideHi-Tech Pharmacal Co. IncANDACurrent
53217-138Buprenorphine and Naloxonebuprenorphine hydrochloride and naloxone hydrochlorideAidarex Pharmaceuticals LLCANDACurrent
60429-586Buprenorphine and Naloxonebuprenorphine hydrochloride and naloxone hydrochlorideGolden State Medical Supply, Inc.ANDACurrent
60429-586Buprenorphine and Naloxonebuprenorphine hydrochloride and naloxone hydrochlorideGolden State Medical Supply Inc.ANDACurrent
60429-586Buprenorphine and Naloxonebuprenorphine hydrochloride and naloxone hydrochlorideGolden State Medical Supply Inc.ANDACurrent
60429-586Buprenorphine and Naloxonebuprenorphine hydrochloride and naloxone hydrochlorideGolden State Medical Supply, Inc.ANDACurrent
60429-586Buprenorphine and Naloxonebuprenorphine hydrochloride and naloxone hydrochlorideGolden State Medical Supply, Inc.ANDACurrent
60429-586Buprenorphine and Naloxonebuprenorphine hydrochloride and naloxone hydrochlorideGolden State Medical Supply, Inc.ANDACurrent
60429-586Buprenorphine and Naloxonebuprenorphine hydrochloride and naloxone hydrochlorideGolden State Medical Supply, Inc.ANDACurrent
60429-586Buprenorphine and Naloxonebuprenorphine hydrochloride and naloxone hydrochlorideGolden State Medical Supply, Inc.ANDACurrent
60429-587Buprenorphine and Naloxonebuprenorphine hydrochloride and naloxone hydrochlorideGolden State Medical Supply, Inc.ANDACurrent
60429-587Buprenorphine and Naloxonebuprenorphine hydrochloride and naloxone hydrochlorideGolden State Medical Supply Inc.ANDACurrent
60429-587Buprenorphine and Naloxonebuprenorphine hydrochloride and naloxone hydrochlorideGolden State Medical Supply Inc.ANDACurrent
60429-587Buprenorphine and Naloxonebuprenorphine hydrochloride and naloxone hydrochlorideGolden State Medical Supply, Inc.ANDACurrent
60429-587Buprenorphine and Naloxonebuprenorphine hydrochloride and naloxone hydrochlorideGolden State Medical Supply, Inc.ANDACurrent
60429-587Buprenorphine and Naloxonebuprenorphine hydrochloride and naloxone hydrochlorideGolden State Medical Supply, Inc.ANDACurrent
60429-587Buprenorphine and Naloxonebuprenorphine hydrochloride and naloxone hydrochlorideGolden State Medical Supply, Inc.ANDACurrent
60429-587Buprenorphine and Naloxonebuprenorphine hydrochloride and naloxone hydrochlorideGolden State Medical Supply, Inc.ANDACurrent
63629-7270Buprenorphine and Naloxonebuprenorphine hydrochloride and naloxone hydrochlorideBryant Ranch PrepackANDACurrent
63629-7270Buprenorphine and Naloxonebuprenorphine hydrochloride and naloxone hydrochlorideBryant Ranch PrepackANDACurrent
63629-7270Buprenorphine and Naloxonebuprenorphine hydrochloride and naloxone hydrochlorideBryant Ranch PrepackANDACurrent
63629-7270Buprenorphine and Naloxonebuprenorphine hydrochloride and naloxone hydrochlorideBryant Ranch PrepackANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
44593ORIG2016-02-03
19561ORIG2015-11-25
32560ORIG2015-10-21