FDA.reportPublic FDA data

Application 070607

Type
ANDA
Sponsor
PERRIGO NEW YORK

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ACETAMINOPHENACETAMINOPHENSUPPOSITORY;RECTAL120MGNoNo

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
A070607-001ACETAMINOPHENACETAMINOPHEN120MGSUPPOSITORY / RECTAL1987-04-06

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 UTC2022-10A070607-001ACETAMINOPHEN120MGSUPPOSITORY / RECTAL1987-04-06f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A070607-001ACETAMINOPHEN120MGSUPPOSITORY / RECTAL1987-04-06e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A070607-001ACETAMINOPHEN120MGSUPPOSITORY / RECTAL1987-04-06cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A070607-001ACETAMINOPHEN120MGSUPPOSITORY / RECTAL1987-04-06a50c72e98297…

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 · 6 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
fever reducing childrensACETAMINOPHENCVS Pharmacy9d89544f-3a66-4f23-b609-381d027e0c952025-06-06WarningsExact identifier
application applno (ANDA): 070607
application number: ANDA070607
ndc (product): 59779-579
Foster and Thrive Pain RelieverACETAMINOPHENStrategic Sourcing Services LLC0a7d82f8-7615-4cef-b245-94b186f3c8fa2025-04-07WarningsExact identifier
application applno (ANDA): 070607
application number: ANDA070607
acetaminophen for childrenACETAMINOPHENNuCare Pharmaceuticals,Inc.5f86e792-3262-4ee6-e053-2991aa0a54a02024-06-06WarningsExact identifier
application applno (ANDA): 070607
application number: ANDA070607
ndc (product): 68071-4172
acetaminophen for childrenACETAMINOPHENNuCare Pharmaceutiacals,Inc.5d7ef1d2-d970-7b01-e053-2991aa0a13112024-06-04WarningsExact identifier
application applno (ANDA): 070607
application number: ANDA070607
ndc (product): 68071-4151
pain reliever fever reducer childrensACETAMINOPHENWalgreen Companyf2085b26-5778-4656-8de3-9edd83f914dd2023-05-03WarningsExact identifier
application applno (ANDA): 070607
application number: ANDA070607
ndc (product): 0363-0579
acetaminophen for childrenACETAMINOPHENProficient Rx LP43fd900c-50c8-49c4-9f07-4fef924d533c2022-09-01WarningsExact identifier
application applno (ANDA): 070607
application number: ANDA070607
ndc (product): 63187-373

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 · 22 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0363-0579pain reliever fever reducerAcetaminophenWalgreen CompanyANDACurrent
0363-0706childrens fever reducerAcetaminophenWalgreen CompanyANDACurrent
0363-0706childrens fever reducerAcetaminophenWalgreen CompanyANDACurrent
0363-0706childrens fever reducerAcetaminophenWalgreen CompanyANDACurrent
45802-732acetaminophenAcetaminophenPerrigo New York IncANDACurrent
45802-732acetaminophenAcetaminophenPadagis Israel Pharmaceuticals LtdANDACurrent
45802-732acetaminophenAcetaminophenPerrigo New York IncANDACurrent
50090-0001acetaminophenAcetaminophenA-S Medication SolutionsANDACurrent
59779-579fever reducingAcetaminophenCVS PharmacyANDACurrent
59779-579fever reducingAcetaminophenCVS PharmacyANDACurrent
63187-373acetaminophenAcetaminophenProficient Rx LPANDACurrent
63187-373acetaminophenAcetaminophenProficient Rx LPANDACurrent
63187-373acetaminophenAcetaminophenProficient Rx LPANDACurrent
63187-373acetaminophenAcetaminophenProficient Rx LPANDACurrent
68071-4151acetaminophenAcetaminophenNuCare Pharmaceutiacals,Inc.ANDACurrent
68071-4151acetaminophenAcetaminophenNuCare Pharmaceutiacals,Inc.ANDACurrent
68071-4151acetaminophenAcetaminophenNuCare Pharmaceutiacals,Inc.ANDACurrent
68071-4172acetaminophenAcetaminophenNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4172acetaminophenAcetaminophenNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4172acetaminophenAcetaminophenNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4172acetaminophenAcetaminophenNuCare Pharmaceuticals,Inc.ANDACurrent
68788-0426acetaminophenAcetaminophenPreferred Pharmaceuticals, Inc.ANDACurrent