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	RLD / RS
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 4 of 5 · 172 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Source SHA-256
2024-02-18 07:12 UTC	2024-02	A085055-001	TYLENOL W/ CODEINE NO. 1	300MG;7.5MG	TABLET / ORAL	Approved before 1982	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A085055-002	TYLENOL W/ CODEINE NO. 2	300MG;15MG	TABLET / ORAL	RLD, Approved before 1982	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A085055-003	TYLENOL W/ CODEINE NO. 3	300MG;30MG	TABLET / ORAL	RLD, Approved before 1982	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A085055-004	TYLENOL W/ CODEINE NO. 4	300MG;60MG	TABLET / ORAL	RLD, Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A085055-001	TYLENOL W/ CODEINE NO. 1	300MG;7.5MG	TABLET / ORAL	Approved before 1982	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A085055-002	TYLENOL W/ CODEINE NO. 2	300MG;15MG	TABLET / ORAL	RLD, Approved before 1982	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A085055-003	TYLENOL W/ CODEINE NO. 3	300MG;30MG	TABLET / ORAL	RLD, Approved before 1982	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A085055-004	TYLENOL W/ CODEINE NO. 4	300MG;60MG	TABLET / ORAL	RLD, Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A085055-001	TYLENOL W/ CODEINE NO. 1	300MG;7.5MG	TABLET / ORAL	Approved before 1982	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A085055-002	TYLENOL W/ CODEINE NO. 2	300MG;15MG	TABLET / ORAL	RLD, Approved before 1982	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A085055-003	TYLENOL W/ CODEINE NO. 3	300MG;30MG	TABLET / ORAL	RLD, Approved before 1982	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A085055-004	TYLENOL W/ CODEINE NO. 4	300MG;60MG	TABLET / ORAL	RLD, Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A085055-001	TYLENOL W/ CODEINE NO. 1	300MG;7.5MG	TABLET / ORAL	Approved before 1982	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A085055-002	TYLENOL W/ CODEINE NO. 2	300MG;15MG	TABLET / ORAL	RLD, Approved before 1982	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A085055-003	TYLENOL W/ CODEINE NO. 3	300MG;30MG	TABLET / ORAL	RLD, Approved before 1982	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A085055-004	TYLENOL W/ CODEINE NO. 4	300MG;60MG	TABLET / ORAL	RLD, Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A085055-001	TYLENOL W/ CODEINE NO. 1	300MG;7.5MG	TABLET / ORAL	Approved before 1982	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A085055-002	TYLENOL W/ CODEINE NO. 2	300MG;15MG	TABLET / ORAL	RLD, Approved before 1982	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A085055-003	TYLENOL W/ CODEINE NO. 3	300MG;30MG	TABLET / ORAL	RLD, Approved before 1982	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A085055-004	TYLENOL W/ CODEINE NO. 4	300MG;60MG	TABLET / ORAL	RLD, Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A085055-001	TYLENOL W/ CODEINE NO. 1	300MG;7.5MG	TABLET / ORAL	Approved before 1982	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A085055-002	TYLENOL W/ CODEINE NO. 2	300MG;15MG	TABLET / ORAL	RLD, Approved before 1982	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A085055-003	TYLENOL W/ CODEINE NO. 3	300MG;30MG	TABLET / ORAL	RLD, Approved before 1982	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A085055-004	TYLENOL W/ CODEINE NO. 4	300MG;60MG	TABLET / ORAL	RLD, Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A085055-001	TYLENOL W/ CODEINE NO. 1	300MG;7.5MG	TABLET / ORAL	Approved before 1982	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A085055-002	TYLENOL W/ CODEINE NO. 2	300MG;15MG	TABLET / ORAL	RLD, Approved before 1982	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A085055-003	TYLENOL W/ CODEINE NO. 3	300MG;30MG	TABLET / ORAL	RLD, Approved before 1982	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A085055-004	TYLENOL W/ CODEINE NO. 4	300MG;60MG	TABLET / ORAL	RLD, Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A085055-001	TYLENOL W/ CODEINE NO. 1	300MG;7.5MG	TABLET / ORAL	Approved before 1982	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A085055-002	TYLENOL W/ CODEINE NO. 2	300MG;15MG	TABLET / ORAL	RLD, Approved before 1982	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A085055-003	TYLENOL W/ CODEINE NO. 3	300MG;30MG	TABLET / ORAL	RLD, Approved before 1982	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A085055-004	TYLENOL W/ CODEINE NO. 4	300MG;60MG	TABLET / ORAL	RLD, Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A085055-001	TYLENOL W/ CODEINE NO. 1	300MG;7.5MG	TABLET / ORAL	Approved before 1982	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A085055-002	TYLENOL W/ CODEINE NO. 2	300MG;15MG	TABLET / ORAL	RLD, Approved before 1982	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A085055-003	TYLENOL W/ CODEINE NO. 3	300MG;30MG	TABLET / ORAL	RLD, Approved before 1982	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A085055-004	TYLENOL W/ CODEINE NO. 4	300MG;60MG	TABLET / ORAL	RLD, Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A085055-001	TYLENOL W/ CODEINE NO. 1	300MG;7.5MG	TABLET / ORAL	Approved before 1982	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A085055-002	TYLENOL W/ CODEINE NO. 2	300MG;15MG	TABLET / ORAL	RLD, Approved before 1982	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A085055-003	TYLENOL W/ CODEINE NO. 3	300MG;30MG	TABLET / ORAL	RLD, Approved before 1982	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A085055-004	TYLENOL W/ CODEINE NO. 4	300MG;60MG	TABLET / ORAL	RLD, Approved before 1982	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A085055-003	AA	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A085055-004	AA	1	`74a2ff9319b5…`
2020-11-12 02:37 UTC	2020-11	A085055-003	AA	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A085055-004	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A085055-003	AA	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A085055-004	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A085055-003	AA	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A085055-004	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A085055-003	AA	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A085055-004	AA	1	`ea99ee380514…`

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