Application 200386

Type: ANDA
Sponsor: TRIS PHARMA INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE	CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE	SYRUP;ORAL	10MG/5ML;6.25MG/5ML	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A200386-001	PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE	CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE	10MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	RS	2012-06-29

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A200386-001	AA

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 1 of 2 · 41 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
2026-02-19 14:30 UTC	2026-02	A200386-001	PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE	10MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	RS	2012-06-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200386-001	PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE	10MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	RS	2012-06-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A200386-001	PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE	10MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	RS	2012-06-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200386-001	PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE	10MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	RS	2012-06-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200386-001	PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE	10MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	RS	2012-06-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200386-001	PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE	10MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	RS	2012-06-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200386-001	PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE	10MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	RS	2012-06-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200386-001	PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE	10MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	RS	2012-06-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200386-001	PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE	10MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	RS	2012-06-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A200386-001	PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE	10MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	RS	2012-06-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200386-001	PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE	10MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	RS	2012-06-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200386-001	PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE	10MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	RS	2012-06-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200386-001	PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE	10MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	RS	2012-06-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A200386-001	PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE	10MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	RS	2012-06-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200386-001	PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE	10MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA		2012-06-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A200386-001	PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE	10MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA		2012-06-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A200386-001	PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE	10MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA		2012-06-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A200386-001	PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE	10MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA		2012-06-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A200386-001	PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE	10MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA		2012-06-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A200386-001	PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE	10MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA		2012-06-29	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A200386-001	PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE	10MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA		2012-06-29	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A200386-001	PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE	10MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA		2012-06-29	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A200386-001	PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE	10MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA		2012-06-29	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A200386-001	PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE	10MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA		2012-06-29	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A200386-001	PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE	10MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA		2012-06-29	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A200386-001	PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE	10MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA		2012-06-29	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A200386-001	PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE	10MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA		2012-06-29	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A200386-001	PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE	10MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	RS	2012-06-29	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A200386-001	PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE	10MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	RS	2012-06-29	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A200386-001	PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE	10MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	RS	2012-06-29	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A200386-001	PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE	10MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	RS	2012-06-29	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A200386-001	PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE	10MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA	RS	2012-06-29	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A200386-001	PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE	10MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA		2012-06-29	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A200386-001	PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE	10MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA		2012-06-29	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A200386-001	PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE	10MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA		2012-06-29	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A200386-001	PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE	10MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA		2012-06-29	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A200386-001	PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE	10MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA		2012-06-29	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A200386-001	PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE	10MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA		2012-06-29	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A200386-001	PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE	10MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA		2012-06-29	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A200386-001	PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE	10MG/5ML;6.25MG/5ML	SYRUP / ORAL	AA		2012-06-29	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A200386-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200386-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A200386-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200386-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200386-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200386-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200386-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200386-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200386-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A200386-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200386-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200386-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200386-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A200386-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200386-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A200386-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A200386-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A200386-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A200386-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A200386-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A200386-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A200386-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A200386-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A200386-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A200386-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A200386-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A200386-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A200386-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A200386-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A200386-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A200386-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A200386-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A200386-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A200386-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A200386-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A200386-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A200386-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A200386-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A200386-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A200386-001	AA	1	`cb3db0bc1861…`

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Promethazine Hydrochloride and Codeine Phosphate	PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE	Cosette Pharmaceuticals, Inc.	3b02cda4-9b24-79c9-e063-6294a90af5b9	2025-12-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200386 application number: ANDA200386
Promethazine Hydrochloride and Codeine Phosphate	PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE	Cranbury Pharmaceuticals, LLC	785c605e-1907-4fac-8b69-d504a2076f8e	2025-12-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200386 application number: ANDA200386 ndc (product): 27808-065
Promethazine Hydrochloride and Codeine Phosphate	PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE	ATLANTIC BIOLOGICALS CORP.	f8fb13e3-bc09-4004-a911-a38b6bbb0058	2025-06-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200386 application number: ANDA200386 ndc (product): 17856-0065
Promethazine Hydrochloride and Codeine Phosphate	PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE	Bryant Ranch Prepack	df2c24ba-1c88-4ec3-b2a1-801358ec645c	2024-04-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200386 application number: ANDA200386

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
17856-0065	Promethazine Hydrochloride and Codeine Phosphate	Promethazine Hydrochloride and Codeine Phosphate	ATLANTIC BIOLOGICALS CORP.	ANDA	Current
27808-065	Promethazine Hydrochloride and Codeine Phosphate	Promethazine Hydrochloride and Codeine Phosphate	Tris Pharma Inc	ANDA	Current