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 2 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	Source SHA-256
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A085055-001	TYLENOL W/ CODEINE NO. 1	300MG;7.5MG	TABLET / ORAL		Approved before 1982	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A085055-002	TYLENOL W/ CODEINE NO. 2	300MG;15MG	TABLET / ORAL		RLD, Approved before 1982	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A085055-003	TYLENOL W/ CODEINE NO. 3	300MG;30MG	TABLET / ORAL		RLD, Approved before 1982	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A085055-004	TYLENOL W/ CODEINE NO. 4	300MG;60MG	TABLET / ORAL		RLD, Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A085055-001	TYLENOL W/ CODEINE NO. 1	300MG;7.5MG	TABLET / ORAL		Approved before 1982	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A085055-002	TYLENOL W/ CODEINE NO. 2	300MG;15MG	TABLET / ORAL		RLD, Approved before 1982	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A085055-003	TYLENOL W/ CODEINE NO. 3	300MG;30MG	TABLET / ORAL		RLD, Approved before 1982	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A085055-004	TYLENOL W/ CODEINE NO. 4	300MG;60MG	TABLET / ORAL		RLD, Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A085055-001	TYLENOL W/ CODEINE NO. 1	300MG;7.5MG	TABLET / ORAL		Approved before 1982	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A085055-002	TYLENOL W/ CODEINE NO. 2	300MG;15MG	TABLET / ORAL		RLD, Approved before 1982	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A085055-003	TYLENOL W/ CODEINE NO. 3	300MG;30MG	TABLET / ORAL		RLD, Approved before 1982	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A085055-004	TYLENOL W/ CODEINE NO. 4	300MG;60MG	TABLET / ORAL		RLD, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A085055-001	TYLENOL W/ CODEINE NO. 1	300MG;7.5MG	TABLET / ORAL		Approved before 1982	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A085055-002	TYLENOL W/ CODEINE NO. 2	300MG;15MG	TABLET / ORAL		RLD, Approved before 1982	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A085055-003	TYLENOL W/ CODEINE NO. 3	300MG;30MG	TABLET / ORAL		RLD, Approved before 1982	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A085055-004	TYLENOL W/ CODEINE NO. 4	300MG;60MG	TABLET / ORAL		RLD, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A085055-001	TYLENOL W/ CODEINE NO. 1	300MG;7.5MG	TABLET / ORAL		Approved before 1982	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A085055-002	TYLENOL W/ CODEINE NO. 2	300MG;15MG	TABLET / ORAL		RLD, Approved before 1982	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A085055-003	TYLENOL W/ CODEINE NO. 3	300MG;30MG	TABLET / ORAL		RLD, Approved before 1982	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A085055-004	TYLENOL W/ CODEINE NO. 4	300MG;60MG	TABLET / ORAL		RLD, Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A085055-001	TYLENOL W/ CODEINE NO. 1	300MG;7.5MG	TABLET / ORAL		Approved before 1982	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A085055-002	TYLENOL W/ CODEINE NO. 2	300MG;15MG	TABLET / ORAL		RLD, Approved before 1982	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A085055-003	TYLENOL W/ CODEINE NO. 3	300MG;30MG	TABLET / ORAL		RLD, Approved before 1982	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A085055-004	TYLENOL W/ CODEINE NO. 4	300MG;60MG	TABLET / ORAL		RLD, Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A085055-001	TYLENOL W/ CODEINE NO. 1	300MG;7.5MG	TABLET / ORAL		Approved before 1982	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A085055-002	TYLENOL W/ CODEINE NO. 2	300MG;15MG	TABLET / ORAL		RLD, Approved before 1982	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A085055-003	TYLENOL W/ CODEINE NO. 3	300MG;30MG	TABLET / ORAL		RLD, Approved before 1982	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A085055-004	TYLENOL W/ CODEINE NO. 4	300MG;60MG	TABLET / ORAL		RLD, Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A085055-001	TYLENOL W/ CODEINE NO. 1	300MG;7.5MG	TABLET / ORAL		Approved before 1982	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A085055-002	TYLENOL W/ CODEINE NO. 2	300MG;15MG	TABLET / ORAL		RLD, Approved before 1982	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A085055-003	TYLENOL W/ CODEINE NO. 3	300MG;30MG	TABLET / ORAL		RLD, Approved before 1982	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A085055-004	TYLENOL W/ CODEINE NO. 4	300MG;60MG	TABLET / ORAL		RLD, Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A085055-001	TYLENOL W/ CODEINE NO. 1	300MG;7.5MG	TABLET / ORAL		Approved before 1982	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A085055-002	TYLENOL W/ CODEINE NO. 2	300MG;15MG	TABLET / ORAL		RLD, Approved before 1982	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A085055-003	TYLENOL W/ CODEINE NO. 3	300MG;30MG	TABLET / ORAL		RLD, Approved before 1982	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A085055-004	TYLENOL W/ CODEINE NO. 4	300MG;60MG	TABLET / ORAL		RLD, Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A085055-001	TYLENOL W/ CODEINE NO. 1	300MG;7.5MG	TABLET / ORAL		Approved before 1982	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A085055-002	TYLENOL W/ CODEINE NO. 2	300MG;15MG	TABLET / ORAL		Approved before 1982	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A085055-003	TYLENOL W/ CODEINE NO. 3	300MG;30MG	TABLET / ORAL	AA	RS, Approved before 1982	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A085055-004	TYLENOL W/ CODEINE NO. 4	300MG;60MG	TABLET / ORAL	AA	Approved before 1982	`74a2ff9319b5…`

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