FDA.reportPublic FDA data

Application 210676

Type
ANDA
Sponsor
AUROBINDO PHARMA LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDEDIPHENHYDRAMINE HYDROCHLORIDE; IBUPROFENCAPSULE;ORAL25MG;EQ 200MG FREE ACID AND POTASSIUM SALTNoNo

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
A210676-001IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDEDIPHENHYDRAMINE HYDROCHLORIDE; IBUPROFEN25MG;EQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2019-02-14

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 UTC2022-10A210676-001IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;EQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2019-02-14f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A210676-001IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;EQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2019-02-14e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A210676-001IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;EQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2019-02-14cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A210676-001IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE25MG;EQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2019-02-14a50c72e98297…

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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Diphenhydramine HCl and IbuprofenDIPHENHYDRAMINE HCL AND IBUPROFENAurohealth LLC39af6dfa-e822-43a5-bd1a-338cf5da89ce2022-12-09WarningsExact identifier
application applno (ANDA): 210676
application number: ANDA210676
ndc (product): 58602-717
Diphenhydramine HCl and IbuprofenDIPHENHYDRAMINE HCL AND IBUPROFENAurohealth LLC2c7c5349-06c9-401a-88e9-8f91ddb7f91a2022-08-19WarningsExact identifier
application applno (ANDA): 210676
application number: ANDA210676
ndc (product): 58602-887
Diphenhydramine HCl and IbuprofenDIPHENHYDRAMINE HCL AND IBUPROFENAurohealth LLCa656f8b0-8cb4-4802-b8d3-7b95c0265d562022-02-21WarningsExact identifier
application applno (ANDA): 210676
application number: ANDA210676
ndc (product): 58602-814

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 · 15 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0363-0250Ibuprofen PMIbuprofen, Diphenhydramine HClWalgreensANDACurrent
0363-0250Ibuprofen PMIbuprofen, Diphenhydramine HClWalgreensANDACurrent
55910-125Ibuprofen PMIbuprofen, Diphenhydramine HCLDolgencorp, Inc. (DOLLAR GENERAL & REXALL)ANDACurrent
55910-125Ibuprofen PMIbuprofen, Diphenhydramine HCLDolgencorp, Inc. (DOLLAR GENERAL & REXALL)ANDACurrent
55910-125Ibuprofen PMIbuprofen, Diphenhydramine HCLDolgencorp, Inc. (DOLLAR GENERAL & REXALL)ANDACurrent
58602-717Diphenhydramine HCl and IbuprofenDiphenhydramine HCl and IbuprofenAurohealth LLCANDACurrent
58602-814Diphenhydramine HCl and IbuprofenDiphenhydramine HCl and IbuprofenAurohealth LLCANDACurrent
58602-814Diphenhydramine HCl and IbuprofenDiphenhydramine HCl and IbuprofenAurohealth LLCANDACurrent
58602-814Diphenhydramine HCl and IbuprofenDiphenhydramine HCl and IbuprofenAurohealth LLCANDACurrent
58602-814Diphenhydramine HCl and IbuprofenDiphenhydramine HCl and IbuprofenAurohealth LLCANDACurrent
58602-814Diphenhydramine HCl and IbuprofenDiphenhydramine HCl and IbuprofenAurohealth LLCANDACurrent
58602-887Diphenhydramine HCl and IbuprofenDiphenhydramine HCl and IbuprofenAurohealth LLCANDACurrent
69842-913Ibuprofen PMIbuprofen, Diphenhydramine HClCVS PharmacyANDACurrent
69842-913Ibuprofen PMIbuprofen, Diphenhydramine HClCVS PharmacyANDACurrent
69842-913Ibuprofen PMIbuprofen, Diphenhydramine HClCVS PharmacyANDACurrent