FDA.reportPublic FDA data

Application 074916

Type
ANDA
Sponsor
P AND L

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001IBUPROFENIBUPROFENSUSPENSION;ORAL100MG/5MLNoNo

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
A074916-001IBUPROFENIBUPROFEN100MG/5MLSUSPENSION / ORAL1999-04-30

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 UTC2022-10A074916-001IBUPROFEN100MG/5MLSUSPENSION / ORAL1999-04-30f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A074916-001IBUPROFEN100MG/5MLSUSPENSION / ORAL1999-04-30e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A074916-001IBUPROFEN100MG/5MLSUSPENSION / ORAL1999-04-30cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A074916-001IBUPROFEN100MG/5MLSUSPENSION / ORAL1999-04-30a50c72e98297…

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Childrens Ibuprofen Oral SuspensionIBUPROFENPharmaceutical Associates, Inc.7a6832f2-2d80-483c-bde3-e6cacb7c318a2022-08-31WarningsExact identifier
application applno (ANDA): 074916
application number: ANDA074916
ndc (product): 0121-0914
ndc (product): 0121-1828

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 2 · 152 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0121-0914Childrens Ibuprofen Oral SuspensionIbuprofenPharmaceutical Associates, Inc.ANDACurrent
0121-0914Childrens Ibuprofen Oral SuspensionIbuprofenPharmaceutical Associates, Inc.ANDACurrent
0121-0914Childrens Ibuprofen Oral SuspensionIbuprofenPharmaceutical Associates, Inc.ANDACurrent
0121-0914Childrens Ibuprofen Oral SuspensionIbuprofenPharmaceutical Associates, Inc.ANDACurrent
0121-0914Childrens Ibuprofen Oral SuspensionIbuprofenPharmaceutical Associates, Inc.ANDACurrent
0121-0917Childrens IbuprofenIbuprofenPharmaceutical Associates, Inc.ANDACurrent
0121-0917Childrens IbuprofenIbuprofenPharmaceutical Associates, Inc.ANDACurrent
0121-0917Childrens IbuprofenIbuprofenPharmaceutical Associates, Inc.ANDACurrent
0121-1820Childrens Ibuprofen Oral SuspensionIbuprofenPharmaceutical Associates, Inc.ANDACurrent
0121-1828Childrens Ibuprofen Oral SuspensionIbuprofenPharmaceutical Associates, Inc.ANDACurrent
0121-1828Childrens Ibuprofen Oral SuspensionIbuprofenPharmaceutical Associates, Inc.ANDACurrent
0121-1828Childrens Ibuprofen Oral SuspensionIbuprofenPharmaceutical Associates, Inc.ANDACurrent
0121-1828Childrens Ibuprofen Oral SuspensionIbuprofenPharmaceutical Associates, Inc.ANDACurrent
0363-1255Childrens IbuprofenIbuprofenWalgreen CompanyANDACurrent
0363-1261Childrens IbuprofenIbuprofenWalgreen CompanyANDACurrent
0363-1262Childrens IbuprofenIbuprofenWalgreen CompanyANDACurrent
0363-1263Childrens IbuprofenIbuprofenWalgreen CompanyANDACurrent
0363-1761Childrens IbuprofenIbuprofenWalgreen CompanyANDACurrent
0363-1761Childrens IbuprofenIbuprofenWalgreensANDACurrent
0363-1761Childrens IbuprofenIbuprofenWalgreensANDACurrent
0363-1762Childrens IbuprofenIbuprofenWalgreen CompanyANDACurrent
0363-1762Childrens IbuprofenIbuprofenWalgreensANDACurrent
0363-1762Childrens IbuprofenIbuprofenWalgreensANDACurrent
0363-1763Childrens IbuprofenIbuprofenWalgreen CompanyANDACurrent
0363-1763Childrens IbuprofenIbuprofenWalgreensANDACurrent
0363-1763Childrens IbuprofenIbuprofenWalgreensANDACurrent
0363-1764Childrens IbuprofenIbuprofenWalgreen CompanyANDACurrent
0363-1764Childrens IbuprofenIbuprofenWalgreensANDACurrent
0363-1764Childrens IbuprofenIbuprofenWalgreensANDACurrent
0363-4560IbuprofenIbuprofenWalgreensANDACurrent
0363-7610Childrens IbuprofenIbuprofenWalgreen CompanyANDACurrent
0363-7610Childrens IbuprofenIbuprofenWalgreensANDACurrent
0363-7610Childrens IbuprofenIbuprofenWalgreensANDACurrent
0363-9370IbuprofenIbuprofenWalgreensANDACurrent
0363-9370IbuprofenIbuprofenWalgreensANDACurrent
0472-1255Childrens IbuprofenIbuprofenActavis Pharma, Inc.ANDACurrent
0472-1261Childrens IbuprofenIbuprofenActavis Pharma, Inc.ANDACurrent
0472-1263Childrens IbuprofenIbuprofenActavis Pharma, Inc.ANDACurrent
0472-1760IbuprofenIbuprofenActavis Pharma, Inc.ANDACurrent
0472-1760IbuprofenIbuprofenActavis Pharma, Inc.ANDACurrent
0472-1760IbuprofenIbuprofenActavis Pharma, Inc.ANDACurrent
0472-1761IbuprofenIbuprofenActavis Pharma, Inc.ANDACurrent
0472-1761IbuprofenIbuprofenActavis Pharma, Inc.ANDACurrent
0472-1761IbuprofenIbuprofenActavis Pharma, Inc.ANDACurrent
0472-1763IbuprofenIbuprofenActavis Pharma, Inc.ANDACurrent
0472-1763IbuprofenIbuprofenActavis Pharma, Inc.ANDACurrent
0472-1763IbuprofenIbuprofenActavis Pharma, Inc.ANDACurrent
0472-1763IbuprofenIbuprofenActavis Pharma, Inc.ANDACurrent
0472-1764IbuprofenIbuprofenActavis Pharma, Inc.ANDACurrent
0472-1764IbuprofenIbuprofenActavis Pharma, Inc.ANDACurrent
0472-1764IbuprofenIbuprofenActavis Pharma, Inc.ANDACurrent
11822-1261Childrens IbuprofenIbuprofenRite AidANDACurrent
11822-1761IbuprofenIbuprofenRite Aid CorporationANDACurrent
11822-1761IbuprofenIbuprofenRite AidANDACurrent
11822-3061IbuprofenIbuprofenRite Aid CorporationANDACurrent
11822-3061IbuprofenIbuprofenRite Aid CorporationANDACurrent
11822-3310IbuprofenIbuprofenRite Aid CorporationANDACurrent
11822-3310IbuprofenIbuprofenRite Aid CorporationANDACurrent
11822-6159IbuprofenIbuprofenRite Aid CorporationANDACurrent
11822-9380IbuprofenIbuprofenRite Aid CorporationANDACurrent
49035-126Childrens IbuprofenIbuprofenWal-Mart Stores IncANDACurrent
49035-716IbuprofenIbuprofenWal-Mart Stores IncANDACurrent
49035-716IbuprofenIbuprofenEQUATE (Wal-Mart Stores, Inc.)ANDACurrent
49035-716IbuprofenIbuprofenEQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)ANDACurrent
50090-2528Childrens IbuprofenIbuprofenA-S Medication SolutionsANDACurrent
50090-3517IbuprofenIbuprofenA-S Medication SolutionsANDACurrent
55319-263Childrens IbuprofenIbuprofenFamily Dollar Services Inc.ANDACurrent
55319-763IbuprofenIbuprofenFamily Dollar Services InANDACurrent
55319-763IbuprofenIbuprofenFamily Dollar Services Inc.ANDACurrent
61269-761Childrens IbuprofenIBUPROFENH2-Pharma, LLCANDACurrent
61269-761Childrens IbuprofenIBUPROFENH2-Pharma, LLCANDACurrent
61269-763Childrens IbuprofenibuprofenH2-Pharma, LLCANDACurrent
61269-763Childrens IbuprofenibuprofenH2-Pharma, LLCANDACurrent
63187-166Childrens IbuprofenIbuprofenProficient Rx LPANDACurrent
63868-709IbuprofenIbuprofenQUALITY CHOICE (Chain Drug Marketing Association)ANDACurrent
63868-709IbuprofenIbuprofenQUALITY CHOICE (Chain Drug Marketing Association)ANDACurrent
63868-709IbuprofenIbuprofenQUALITY CHOICE (Chain Drug Marketing Association)ANDACurrent
63868-724IbuprofenIbuprofenQUALITY CHOICE (Chain Drug Marketing Association)ANDACurrent
63868-724IbuprofenIbuprofenQUALITY CHOICE (Chain Drug Marketing Association)ANDACurrent
63868-724IbuprofenIbuprofenQUALITY CHOICE (Chain Drug Marketing Association)ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
8463ORIG1998-01-09