FDA.reportPublic FDA data

Application 040446

Type
ANDA
Sponsor
SUN PHARM INDS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MEPERIDINE HYDROCHLORIDEMEPERIDINE HYDROCHLORIDETABLET;ORAL50MGNoNo
002MEPERIDINE HYDROCHLORIDEMEPERIDINE HYDROCHLORIDETABLET;ORAL100MGNoNo

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

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
A040446-001MEPERIDINE HYDROCHLORIDEMEPERIDINE HYDROCHLORIDE50MGTABLET / ORAL2002-08-08
A040446-002MEPERIDINE HYDROCHLORIDEMEPERIDINE HYDROCHLORIDE100MGTABLET / ORAL2002-08-08

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 3 of 3 · 88 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10A040446-001MEPERIDINE HYDROCHLORIDE50MGTABLET / ORAL2002-08-08f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10A040446-002MEPERIDINE HYDROCHLORIDE100MGTABLET / ORAL2002-08-08f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A040446-001MEPERIDINE HYDROCHLORIDE50MGTABLET / ORAL2002-08-08e64feba35796…
2022-09-29 23:25 UTC2022-09A040446-002MEPERIDINE HYDROCHLORIDE100MGTABLET / ORAL2002-08-08e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A040446-001MEPERIDINE HYDROCHLORIDE50MGTABLET / ORAL2002-08-08cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A040446-002MEPERIDINE HYDROCHLORIDE100MGTABLET / ORAL2002-08-08cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A040446-001MEPERIDINE HYDROCHLORIDE50MGTABLET / ORAL2002-08-08a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A040446-002MEPERIDINE HYDROCHLORIDE100MGTABLET / ORAL2002-08-08a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-09-15 20:21 UTC2019-09A040446-001AA1b00525d2431f…
2019-09-15 20:21 UTC2019-09A040446-002AA1b00525d2431f…
2019-07-19 19:46 UTC2019-07A040446-001AA1ea99ee380514…
2019-07-19 19:46 UTC2019-07A040446-002AA1ea99ee380514…

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 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DEMEROLMEPERIDINE HYDROCHLORIDEHospira, Inc.b31d1308-28c3-43f4-e0a6-2f3ed76b89752026-07-20Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MEPERIDINE HYDROCHLORIDE
Meperidine HydrochlorideMEPERIDINE HYDROCHLORIDEHikma Pharmaceuticals USA Inc.15bc51a8-1e24-4d33-9a2f-05a41c29acf02026-02-27Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Meperidine Hydrochloride
generic name: MEPERIDINE HYDROCHLORIDE
Meperidine HydrochlorideMEPERIDINE HYDROCHLORIDEGenus Lifesciences Inc.792fefda-6cc4-4709-b902-fd9787fc310a2026-02-13Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Meperidine Hydrochloride
generic name: MEPERIDINE HYDROCHLORIDE
Meperidine HydrochlorideMEPERIDINE HYDROCHLORIDEEPIC PHARMA, LLCfae5cc34-5917-4445-9516-25f97ffca8db2025-11-29Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Meperidine Hydrochloride
generic name: MEPERIDINE HYDROCHLORIDE
MEPERIDINE HYDROCHLORIDEMEPERIDINE HYDROCHLORIDEHikma Pharmaceuticals USA Inc.e0e998da-f056-4fce-be8e-ed60cf3b461b2024-04-09Boxed warning, Warnings, Adverse reactionsName fallback
brand name: MEPERIDINE HYDROCHLORIDE
generic name: MEPERIDINE 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 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
57664-467meperidine hydrochloridemeperidine hydrochlorideCaraco Pharmaceutical Laboratories, Ltd.ANDACurrent
57664-471meperidine hydrochloridemeperidine hydrochlorideCaraco Pharmaceutical Laboratories, Ltd.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
76091ORIG 2023-11-02
76087ORIG 2023-11-02
29959ORIG2003-04-09