Home Applications 085055 Application 085055
Type ANDA
Sponsor JANSSEN PHARMS Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 TYLENOL W/ CODEINE NO. 1 ACETAMINOPHEN; CODEINE PHOSPHATE TABLET;ORAL 300MG;7.5MG No No 002 TYLENOL W/ CODEINE NO. 2 ACETAMINOPHEN; CODEINE PHOSPHATE TABLET;ORAL 300MG;15MG No No 003 TYLENOL W/ CODEINE NO. 3 ACETAMINOPHEN; CODEINE PHOSPHATE TABLET;ORAL 300MG;30MG No Yes 004 TYLENOL W/ CODEINE NO. 4 ACETAMINOPHEN; CODEINE PHOSPHATE TABLET;ORAL 300MG;60MG No No
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A085055-001 TYLENOL W/ CODEINE NO. 1 ACETAMINOPHEN; CODEINE PHOSPHATE 300MG;7.5MG TABLET / ORAL Approved before 1982 A085055-002 TYLENOL W/ CODEINE NO. 2 ACETAMINOPHEN; CODEINE PHOSPHATE 300MG;15MG TABLET / ORAL RLD, Approved before 1982 A085055-003 TYLENOL W/ CODEINE NO. 3 ACETAMINOPHEN; CODEINE PHOSPHATE 300MG;30MG TABLET / ORAL RLD, Approved before 1982 A085055-004 TYLENOL W/ CODEINE NO. 4 ACETAMINOPHEN; CODEINE PHOSPHATE 300MG;60MG TABLET / ORAL RLD, 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 3 of 5 · 172 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2022-03-09 01:35 UTC 2022-03 A085055-001 TYLENOL W/ CODEINE NO. 1 300MG;7.5MG TABLET / ORAL Approved before 1982 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A085055-002 TYLENOL W/ CODEINE NO. 2 300MG;15MG TABLET / ORAL RLD, Approved before 1982 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A085055-003 TYLENOL W/ CODEINE NO. 3 300MG;30MG TABLET / ORAL RLD, Approved before 1982 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A085055-004 TYLENOL W/ CODEINE NO. 4 300MG;60MG TABLET / ORAL RLD, Approved before 1982 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A085055-001 TYLENOL W/ CODEINE NO. 1 300MG;7.5MG TABLET / ORAL Approved before 1982 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A085055-002 TYLENOL W/ CODEINE NO. 2 300MG;15MG TABLET / ORAL RLD, Approved before 1982 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A085055-003 TYLENOL W/ CODEINE NO. 3 300MG;30MG TABLET / ORAL RLD, Approved before 1982 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A085055-004 TYLENOL W/ CODEINE NO. 4 300MG;60MG TABLET / ORAL RLD, Approved before 1982 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A085055-001 TYLENOL W/ CODEINE NO. 1 300MG;7.5MG TABLET / ORAL Approved before 1982 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A085055-002 TYLENOL W/ CODEINE NO. 2 300MG;15MG TABLET / ORAL Approved before 1982 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A085055-003 TYLENOL W/ CODEINE NO. 3 300MG;30MG TABLET / ORAL Approved before 1982 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A085055-004 TYLENOL W/ CODEINE NO. 4 300MG;60MG TABLET / ORAL Approved before 1982 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A085055-001 TYLENOL W/ CODEINE NO. 1 300MG;7.5MG TABLET / ORAL Approved before 1982 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 A085055-002 TYLENOL W/ CODEINE NO. 2 300MG;15MG TABLET / ORAL Approved before 1982 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 A085055-003 TYLENOL W/ CODEINE NO. 3 300MG;30MG TABLET / ORAL Approved before 1982 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 A085055-004 TYLENOL W/ CODEINE NO. 4 300MG;60MG TABLET / ORAL Approved before 1982 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A085055-001 TYLENOL W/ CODEINE NO. 1 300MG;7.5MG TABLET / ORAL Approved before 1982 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 A085055-002 TYLENOL W/ CODEINE NO. 2 300MG;15MG TABLET / ORAL Approved before 1982 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 A085055-003 TYLENOL W/ CODEINE NO. 3 300MG;30MG TABLET / ORAL Approved before 1982 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 A085055-004 TYLENOL W/ CODEINE NO. 4 300MG;60MG TABLET / ORAL Approved before 1982 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A085055-001 TYLENOL W/ CODEINE NO. 1 300MG;7.5MG TABLET / ORAL Approved before 1982 c0c555d07b60…2020-11-12 02:37 UTC 2020-11 A085055-002 TYLENOL W/ CODEINE NO. 2 300MG;15MG TABLET / ORAL Approved before 1982 c0c555d07b60…2020-11-12 02:37 UTC 2020-11 A085055-003 TYLENOL W/ CODEINE NO. 3 300MG;30MG TABLET / ORAL AA RS, Approved before 1982 c0c555d07b60…2020-11-12 02:37 UTC 2020-11 A085055-004 TYLENOL W/ CODEINE NO. 4 300MG;60MG TABLET / ORAL AA Approved before 1982 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A085055-001 TYLENOL W/ CODEINE NO. 1 300MG;7.5MG TABLET / ORAL Approved before 1982 3f01610625f2…2019-12-14 00:12 UTC 2019-12 A085055-002 TYLENOL W/ CODEINE NO. 2 300MG;15MG TABLET / ORAL Approved before 1982 3f01610625f2…2019-12-14 00:12 UTC 2019-12 A085055-003 TYLENOL W/ CODEINE NO. 3 300MG;30MG TABLET / ORAL AA RS, Approved before 1982 3f01610625f2…2019-12-14 00:12 UTC 2019-12 A085055-004 TYLENOL W/ CODEINE NO. 4 300MG;60MG TABLET / ORAL AA Approved before 1982 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A085055-001 TYLENOL W/ CODEINE NO. 1 300MG;7.5MG TABLET / ORAL Approved before 1982 b00525d2431f…2019-09-15 20:21 UTC 2019-09 A085055-002 TYLENOL W/ CODEINE NO. 2 300MG;15MG TABLET / ORAL Approved before 1982 b00525d2431f…2019-09-15 20:21 UTC 2019-09 A085055-003 TYLENOL W/ CODEINE NO. 3 300MG;30MG TABLET / ORAL AA RS, Approved before 1982 b00525d2431f…2019-09-15 20:21 UTC 2019-09 A085055-004 TYLENOL W/ CODEINE NO. 4 300MG;60MG TABLET / ORAL AA Approved before 1982 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A085055-001 TYLENOL W/ CODEINE NO. 1 300MG;7.5MG TABLET / ORAL Approved before 1982 ea99ee380514…2019-07-19 19:46 UTC 2019-07 A085055-002 TYLENOL W/ CODEINE NO. 2 300MG;15MG TABLET / ORAL Approved before 1982 ea99ee380514…2019-07-19 19:46 UTC 2019-07 A085055-003 TYLENOL W/ CODEINE NO. 3 300MG;30MG TABLET / ORAL AA RS, Approved before 1982 ea99ee380514…2019-07-19 19:46 UTC 2019-07 A085055-004 TYLENOL W/ CODEINE NO. 4 300MG;60MG TABLET / ORAL AA Approved before 1982 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A085055-001 TYLENOL W/ CODEINE NO. 1 300MG;7.5MG TABLET / ORAL Approved before 1982 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A085055-002 TYLENOL W/ CODEINE NO. 2 300MG;15MG TABLET / ORAL RLD, Approved before 1982 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A085055-003 TYLENOL W/ CODEINE NO. 3 300MG;30MG TABLET / ORAL RLD, Approved before 1982 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A085055-004 TYLENOL W/ CODEINE NO. 4 300MG;60MG TABLET / ORAL RLD, Approved before 1982 6a51e52b5d6a…
Observed Orange Book normalized TE history# 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 NDC Name Nonproprietary name Labeler Marketing category Status 50090-0006 TYLENOL with Codeine acetaminophen and codeine phosphate A-S Medication Solutions ANDA Current 50090-0006 TYLENOL with Codeine acetaminophen and codeine phosphate A-S Medication Solutions ANDA Current 50458-513 TYLENOL with Codeine acetaminophen and codeine phosphate Janssen Pharmaceuticals, Inc. ANDA Current 50458-513 TYLENOL with Codeine acetaminophen and codeine phosphate Janssen Pharmaceuticals, Inc. ANDA Current 50458-513 TYLENOL with Codeine acetaminophen and codeine phosphate Janssen Pharmaceuticals, Inc. ANDA Current 50458-513 TYLENOL with Codeine acetaminophen and codeine phosphate Janssen Pharmaceuticals, Inc. ANDA Current 50458-513 TYLENOL with Codeine acetaminophen and codeine phosphate Janssen Pharmaceuticals, Inc. ANDA Current 50458-515 TYLENOL with Codeine acetaminophen and codeine phosphate Janssen Pharmaceuticals, Inc. ANDA Current 50458-515 TYLENOL with Codeine acetaminophen and codeine phosphate Janssen Pharmaceuticals, Inc. ANDA Current 50458-515 TYLENOL with Codeine acetaminophen and codeine phosphate Janssen Pharmaceuticals, Inc. ANDA Current 50458-515 TYLENOL with Codeine acetaminophen and codeine phosphate Janssen Pharmaceuticals, Inc. ANDA Current 50458-515 TYLENOL with Codeine acetaminophen and codeine phosphate Janssen Pharmaceuticals, Inc. ANDA Current