FDA.reportPublic FDA data

Application 209069

Type
ANDA
Sponsor
WES PHARMA INC

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
A209069-001BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDEBUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDEEQ 2MG BASE;EQ 0.5MG BASETABLET / SUBLINGUALAB2020-07-17
A209069-002BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDEBUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDEEQ 8MG BASE;EQ 2MG BASETABLET / SUBLINGUALAB2020-07-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A209069-001AB
A209069-002AB

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 22:54:322026-06A209069-001BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDEEQ 2MG BASE;EQ 0.5MG BASETABLET / SUBLINGUALAB2020-07-17a50c72e98297…
2026-08-01 22:54:322026-06A209069-002BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDEEQ 8MG BASE;EQ 2MG BASETABLET / SUBLINGUALAB2020-07-17a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A209069-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A209069-002AB1a50c72e98297…

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 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BUPRENORPHINE HYDROCHLORIDE and NALOXONE HYDROCHLORIDE DIHYDRATEBUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE DIHYDRATEClinical Solutions Wholesale, LLC8f2b94dc-f42f-45d5-8274-9e748ec20ef02026-03-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209069
application number: ANDA209069
BUPRENORPHINE HYDROCHLORIDE and NALOXONE HYDROCHLORIDE DIHYDRATEBUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE DIHYDRATERedpharm Drug44f2e26f-4586-5204-e063-6394a90a47d52026-01-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209069
application number: ANDA209069
BUPRENORPHINE HYDROCHLORIDE and NALOXONE HYDROCHLORIDE DIHYDRATEBUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE DIHYDRATEBryant Ranch Prepack53457b0d-3462-489e-8cf5-7cdc2ecffb482023-11-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209069
application number: ANDA209069
ndc (product): 71335-1858
BUPRENORPHINE HYDROCHLORIDE and NALOXONE HYDROCHLORIDE DIHYDRATEBUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE DIHYDRATEAccord Healthcare, Inc35d29e9b-9950-452a-a795-5a7514f0edfd2023-05-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209069
application number: ANDA209069
ndc (product): 16729-549
ndc (product): 16729-550
BUPRENORPHINE HYDROCHLORIDE and NALOXONE HYDROCHLORIDE DIHYDRATEBUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE DIHYDRATEAsclemed USA, Inc.597cbc69-84b1-4255-bed9-53d0c6dc21342023-01-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209069
application number: ANDA209069

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
16729-549BUPRENORPHINE HYDROCHLORIDE and NALOXONE HYDROCHLORIDE DIHYDRATEBUPRENORPHINE HYDROCHLORIDE and NALOXONE HYDROCHLORIDE DIHYDRATEAccord Healthcare, IncANDACurrent
16729-549BUPRENORPHINE HYDROCHLORIDE and NALOXONE HYDROCHLORIDE DIHYDRATEBUPRENORPHINE HYDROCHLORIDE and NALOXONE HYDROCHLORIDE DIHYDRATEAccord Healthcare, IncANDACurrent
16729-550BUPRENORPHINE HYDROCHLORIDE and NALOXONE HYDROCHLORIDE DIHYDRATEBUPRENORPHINE HYDROCHLORIDE and NALOXONE HYDROCHLORIDE DIHYDRATEAccord Healthcare, IncANDACurrent
16729-550BUPRENORPHINE HYDROCHLORIDE and NALOXONE HYDROCHLORIDE DIHYDRATEBUPRENORPHINE HYDROCHLORIDE and NALOXONE HYDROCHLORIDE DIHYDRATEAccord Healthcare, IncANDACurrent
71335-1858BUPRENORPHINE HYDROCHLORIDE and NALOXONE HYDROCHLORIDE DIHYDRATEBUPRENORPHINE HYDROCHLORIDE and NALOXONE HYDROCHLORIDE DIHYDRATEBryant Ranch PrepackANDACurrent
71335-1858BUPRENORPHINE HYDROCHLORIDE and NALOXONE HYDROCHLORIDE DIHYDRATEBUPRENORPHINE HYDROCHLORIDE and NALOXONE HYDROCHLORIDE DIHYDRATEBryant Ranch PrepackANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
76395ORIG 2023-11-06