FDA.reportPublic FDA data

Application 085055

Type
ANDA
Sponsor
JANSSEN PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TYLENOL W/ CODEINE NO. 1ACETAMINOPHEN; CODEINE PHOSPHATETABLET;ORAL300MG;7.5MGNoNo
002TYLENOL W/ CODEINE NO. 2ACETAMINOPHEN; CODEINE PHOSPHATETABLET;ORAL300MG;15MGNoNo
003TYLENOL W/ CODEINE NO. 3ACETAMINOPHEN; CODEINE PHOSPHATETABLET;ORAL300MG;30MGNoYes
004TYLENOL W/ CODEINE NO. 4ACETAMINOPHEN; CODEINE PHOSPHATETABLET;ORAL300MG;60MGNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A085055-001TYLENOL W/ CODEINE NO. 1ACETAMINOPHEN; CODEINE PHOSPHATE300MG;7.5MGTABLET / ORALApproved before 1982
A085055-002TYLENOL W/ CODEINE NO. 2ACETAMINOPHEN; CODEINE PHOSPHATE300MG;15MGTABLET / ORALRLD, Approved before 1982
A085055-003TYLENOL W/ CODEINE NO. 3ACETAMINOPHEN; CODEINE PHOSPHATE300MG;30MGTABLET / ORALRLD, Approved before 1982
A085055-004TYLENOL W/ CODEINE NO. 4ACETAMINOPHEN; CODEINE PHOSPHATE300MG;60MGTABLET / ORALRLD, Approved before 1982

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 5 of 5 · 172 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-09-29 23:25 UTC2022-09A085055-001TYLENOL W/ CODEINE NO. 1300MG;7.5MGTABLET / ORALApproved before 1982e64feba35796…
2022-09-29 23:25 UTC2022-09A085055-002TYLENOL W/ CODEINE NO. 2300MG;15MGTABLET / ORALRLD, Approved before 1982e64feba35796…
2022-09-29 23:25 UTC2022-09A085055-003TYLENOL W/ CODEINE NO. 3300MG;30MGTABLET / ORALRLD, Approved before 1982e64feba35796…
2022-09-29 23:25 UTC2022-09A085055-004TYLENOL W/ CODEINE NO. 4300MG;60MGTABLET / ORALRLD, Approved before 1982e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A085055-001TYLENOL W/ CODEINE NO. 1300MG;7.5MGTABLET / ORALApproved before 1982cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A085055-002TYLENOL W/ CODEINE NO. 2300MG;15MGTABLET / ORALRLD, Approved before 1982cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A085055-003TYLENOL W/ CODEINE NO. 3300MG;30MGTABLET / ORALRLD, Approved before 1982cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A085055-004TYLENOL W/ CODEINE NO. 4300MG;60MGTABLET / ORALRLD, Approved before 1982cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A085055-001TYLENOL W/ CODEINE NO. 1300MG;7.5MGTABLET / ORALApproved before 1982a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A085055-002TYLENOL W/ CODEINE NO. 2300MG;15MGTABLET / ORALRLD, Approved before 1982a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A085055-003TYLENOL W/ CODEINE NO. 3300MG;30MGTABLET / ORALRLD, Approved before 1982a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A085055-004TYLENOL W/ CODEINE NO. 4300MG;60MGTABLET / ORALRLD, Approved before 1982a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12A085055-003AA174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A085055-004AA174a2ff9319b5…
2020-11-12 02:37 UTC2020-11A085055-003AA1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A085055-004AA1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A085055-003AA13f01610625f2…
2019-12-14 00:12 UTC2019-12A085055-004AA13f01610625f2…
2019-09-15 20:21 UTC2019-09A085055-003AA1b00525d2431f…
2019-09-15 20:21 UTC2019-09A085055-004AA1b00525d2431f…
2019-07-19 19:46 UTC2019-07A085055-003AA1ea99ee380514…
2019-07-19 19:46 UTC2019-07A085055-004AA1ea99ee380514…

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 · 12 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50090-0006TYLENOL with Codeineacetaminophen and codeine phosphateA-S Medication SolutionsANDACurrent
50090-0006TYLENOL with Codeineacetaminophen and codeine phosphateA-S Medication SolutionsANDACurrent
50458-513TYLENOL with Codeineacetaminophen and codeine phosphateJanssen Pharmaceuticals, Inc.ANDACurrent
50458-513TYLENOL with Codeineacetaminophen and codeine phosphateJanssen Pharmaceuticals, Inc.ANDACurrent
50458-513TYLENOL with Codeineacetaminophen and codeine phosphateJanssen Pharmaceuticals, Inc.ANDACurrent
50458-513TYLENOL with Codeineacetaminophen and codeine phosphateJanssen Pharmaceuticals, Inc.ANDACurrent
50458-513TYLENOL with Codeineacetaminophen and codeine phosphateJanssen Pharmaceuticals, Inc.ANDACurrent
50458-515TYLENOL with Codeineacetaminophen and codeine phosphateJanssen Pharmaceuticals, Inc.ANDACurrent
50458-515TYLENOL with Codeineacetaminophen and codeine phosphateJanssen Pharmaceuticals, Inc.ANDACurrent
50458-515TYLENOL with Codeineacetaminophen and codeine phosphateJanssen Pharmaceuticals, Inc.ANDACurrent
50458-515TYLENOL with Codeineacetaminophen and codeine phosphateJanssen Pharmaceuticals, Inc.ANDACurrent
50458-515TYLENOL with Codeineacetaminophen and codeine phosphateJanssen Pharmaceuticals, Inc.ANDACurrent