FDA.reportPublic FDA data

Application 205702

Type
ANDA
Sponsor
MACLEODS PHARMS LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDETABLET;ORAL50MGNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A205702-001TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDE50MGTABLET / ORAL2015-09-25

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 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10A205702-001TRAMADOL HYDROCHLORIDE50MGTABLET / ORAL2015-09-25f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A205702-001TRAMADOL HYDROCHLORIDE50MGTABLET / ORAL2015-09-25e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A205702-001TRAMADOL HYDROCHLORIDE50MGTABLET / ORAL2015-09-25cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A205702-001TRAMADOL HYDROCHLORIDE50MGTABLET / ORAL2015-09-25a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12A205702-001AB174a2ff9319b5…
2019-12-14 00:12 UTC2019-12A205702-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A205702-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A205702-001AB1ea99ee380514…

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 5 · 91 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
tramadol hydrochlorideTRAMADOL HYDROCHLORIDEREMEDYREPACK INC.c6104e62-5b2c-41a1-afb3-00dcf267a3842026-09-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: tramadol hydrochloride
generic name: TRAMADOL HYDROCHLORIDE
tramadol hydrochlorideTRAMADOL HYDROCHLORIDEStrides Pharma Science Limiteda6cbd5de-8ae5-49e3-b89b-e35536b115d82026-08-27Boxed warning, Warnings, Adverse reactionsName fallback
brand name: tramadol hydrochloride
generic name: TRAMADOL HYDROCHLORIDE
Tramadol HydrochlorideTRAMADOL HYDROCHLORIDEAurobindo Pharma Limitede5005d9e-91cb-4ff8-bcf2-b5ee70cf4f3f2026-08-25Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Tramadol Hydrochloride
generic name: TRAMADOL HYDROCHLORIDE
TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDEREMEDYREPACK INC.16053b28-c759-4914-93e6-2de0afe724452026-07-02Boxed warning, Warnings, Adverse reactionsName fallback
brand name: TRAMADOL HYDROCHLORIDE
generic name: TRAMADOL HYDROCHLORIDE
Tramadol HydrochlorideTRAMADOL HYDROCHLORIDESt. Mary's Medical Park Pharmacy42de8c3a-0441-5d46-e063-6294a90a20792026-07-02Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Tramadol Hydrochloride
generic name: TRAMADOL HYDROCHLORIDE
TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDEREMEDYREPACK INC.6bb5be12-59ff-40f4-9841-9c7ab93be2ea2026-07-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: TRAMADOL HYDROCHLORIDE
generic name: TRAMADOL HYDROCHLORIDE
Tramadol HydrochlorideTRAMADOL HYDROCHLORIDEAdvanced Rx of Tennessee, LLC552e5b32-accf-29dd-e063-6294a90a4fcf2026-06-26Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Tramadol Hydrochloride
generic name: TRAMADOL HYDROCHLORIDE
Tramadol HydrochlorideTRAMADOL HYDROCHLORIDENorthwind Health Company, LLC552955e6-2bb3-8755-e063-6394a90ab21c2026-06-25Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Tramadol Hydrochloride
generic name: TRAMADOL HYDROCHLORIDE
Tramadol HydrochlorideTRAMADOL HYDROCHLORIDECoupler LLC54d74939-301b-e603-e063-6394a90a3b032026-06-22Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Tramadol Hydrochloride
generic name: TRAMADOL HYDROCHLORIDE
Tramadol HydrochlorideTRAMADOL HYDROCHLORIDEBryant Ranch Prepack515baa9a-b226-4bbe-be87-f9befdf1c9e12026-06-18Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Tramadol Hydrochloride
generic name: TRAMADOL HYDROCHLORIDE
Tramadol HydrochlorideTRAMADOL HYDROCHLORIDEREMEDYREPACK INC.5199132e-745e-46a0-8068-e06d1bca5c612026-06-15Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Tramadol Hydrochloride
generic name: TRAMADOL HYDROCHLORIDE
Tramadol HydrochlorideTRAMADOL HYDROCHLORIDEPreferred Pharmaceuticals Inc.855905c7-1481-4b2d-a318-3254ad8ed73c2026-06-08Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Tramadol Hydrochloride
generic name: TRAMADOL HYDROCHLORIDE
Tramadol HydrochlorideTRAMADOL HYDROCHLORIDEProficient Rx LPaefc85bc-0820-4aee-8d94-313c5f1658f52026-06-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Tramadol Hydrochloride
generic name: TRAMADOL HYDROCHLORIDE
Tramadol HydrochlorideTRAMADOL HYDROCHLORIDEMajor Pharmaceuticals6b0b95b2-ae4c-42e8-9f2e-bcdaffda62e22026-05-28Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Tramadol Hydrochloride
generic name: TRAMADOL HYDROCHLORIDE
TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDEBryant Ranch Prepack66359f41-9999-4cb8-b632-1fe2ec1e60b22026-05-13Boxed warning, Warnings, Adverse reactionsName fallback
brand name: TRAMADOL HYDROCHLORIDE
generic name: TRAMADOL HYDROCHLORIDE
TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDEBryant Ranch Prepack43fe10b2-17a4-4dc2-9a48-2378547b61fd2026-05-13Boxed warning, Warnings, Adverse reactionsName fallback
brand name: TRAMADOL HYDROCHLORIDE
generic name: TRAMADOL HYDROCHLORIDE
Tramadol HydrochlorideTRAMADOL HYDROCHLORIDEST. MARY'S MEDICAL PARK PHARMACYf2f421ab-35ae-7637-e053-2995a90a40e02026-05-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Tramadol Hydrochloride
generic name: TRAMADOL HYDROCHLORIDE
Tramadol HydrochlorideTRAMADOL HYDROCHLORIDEBryant Ranch Prepack674803a0-4cf5-4416-a5e3-c1a1e332cdcd2026-04-13Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Tramadol Hydrochloride
generic name: TRAMADOL HYDROCHLORIDE
TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDEBryant Ranch Prepackacd5d8e0-a4cc-4654-ae04-faff347a60ca2026-04-13Boxed warning, Warnings, Adverse reactionsName fallback
brand name: TRAMADOL HYDROCHLORIDE
generic name: TRAMADOL HYDROCHLORIDE
Tramadol HydrochlorideTRAMADOL HYDROCHLORIDEUnichem Pharmaceuticals (USA), Inc.007bf37f-0e46-426a-ac8c-be63d4b7414c2026-04-10Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Tramadol Hydrochloride
generic name: TRAMADOL HYDROCHLORIDE

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 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
33342-201Tramadol HydrochlorideTramadol HydrochlorideMacleods Pharmaceuticals LimitedANDACurrent
33342-201Tramadol HydrochlorideTramadol HydrochlorideMacleods Pharmaceuticals LimitedANDACurrent
33342-201Tramadol HydrochlorideTramadol HydrochlorideMacleods Pharmaceuticals LimitedANDACurrent
67296-1402Tramadol HydrochlorideTramadol HydrochlorideRedPharm Drug, Inc.ANDACurrent
67296-1402Tramadol HydrochlorideTramadol HydrochlorideRedPharm Drug, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
76105ORIG 2023-11-02