Application 203518

Type: ANDA
Sponsor: TRIS PHARMA INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	MORPHINE SULFATE	MORPHINE SULFATE	SOLUTION;ORAL	10MG/5ML	No	No
002	MORPHINE SULFATE	MORPHINE SULFATE	SOLUTION;ORAL	100MG/5ML	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A203518-001	MORPHINE SULFATE	MORPHINE SULFATE	10MG/5ML	SOLUTION / ORAL			2015-05-12
A203518-002	MORPHINE SULFATE	MORPHINE SULFATE	100MG/5ML	SOLUTION / ORAL	AA		2015-05-12

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A203518-002	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 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A203518-001	MORPHINE SULFATE	10MG/5ML	SOLUTION / ORAL		2015-05-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203518-002	MORPHINE SULFATE	100MG/5ML	SOLUTION / ORAL	AA	2015-05-12	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203518-001	MORPHINE SULFATE	10MG/5ML	SOLUTION / ORAL	AA	2015-05-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203518-002	MORPHINE SULFATE	100MG/5ML	SOLUTION / ORAL	AA	2015-05-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203518-001	MORPHINE SULFATE	10MG/5ML	SOLUTION / ORAL	AA	2015-05-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203518-002	MORPHINE SULFATE	100MG/5ML	SOLUTION / ORAL	AA	2015-05-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203518-001	MORPHINE SULFATE	10MG/5ML	SOLUTION / ORAL	AA	2015-05-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203518-002	MORPHINE SULFATE	100MG/5ML	SOLUTION / ORAL	AA	2015-05-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203518-001	MORPHINE SULFATE	10MG/5ML	SOLUTION / ORAL	AA	2015-05-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203518-002	MORPHINE SULFATE	100MG/5ML	SOLUTION / ORAL	AA	2015-05-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203518-001	MORPHINE SULFATE	10MG/5ML	SOLUTION / ORAL	AA	2015-05-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203518-002	MORPHINE SULFATE	100MG/5ML	SOLUTION / ORAL	AA	2015-05-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203518-001	MORPHINE SULFATE	10MG/5ML	SOLUTION / ORAL	AA	2015-05-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203518-002	MORPHINE SULFATE	100MG/5ML	SOLUTION / ORAL	AA	2015-05-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203518-001	MORPHINE SULFATE	10MG/5ML	SOLUTION / ORAL	AA	2015-05-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203518-002	MORPHINE SULFATE	100MG/5ML	SOLUTION / ORAL	AA	2015-05-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203518-001	MORPHINE SULFATE	10MG/5ML	SOLUTION / ORAL	AA	2015-05-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203518-002	MORPHINE SULFATE	100MG/5ML	SOLUTION / ORAL	AA	2015-05-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203518-001	MORPHINE SULFATE	10MG/5ML	SOLUTION / ORAL	AA	2015-05-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203518-002	MORPHINE SULFATE	100MG/5ML	SOLUTION / ORAL	AA	2015-05-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203518-001	MORPHINE SULFATE	10MG/5ML	SOLUTION / ORAL	AA	2015-05-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203518-002	MORPHINE SULFATE	100MG/5ML	SOLUTION / ORAL	AA	2015-05-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203518-001	MORPHINE SULFATE	10MG/5ML	SOLUTION / ORAL	AA	2015-05-12	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203518-002	MORPHINE SULFATE	100MG/5ML	SOLUTION / ORAL	AA	2015-05-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203518-001	MORPHINE SULFATE	10MG/5ML	SOLUTION / ORAL	AA	2015-05-12	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203518-002	MORPHINE SULFATE	100MG/5ML	SOLUTION / ORAL	AA	2015-05-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203518-001	MORPHINE SULFATE	10MG/5ML	SOLUTION / ORAL	AA	2015-05-12	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203518-002	MORPHINE SULFATE	100MG/5ML	SOLUTION / ORAL	AA	2015-05-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203518-001	MORPHINE SULFATE	10MG/5ML	SOLUTION / ORAL	AA	2015-05-12	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A203518-002	MORPHINE SULFATE	100MG/5ML	SOLUTION / ORAL	AA	2015-05-12	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203518-001	MORPHINE SULFATE	10MG/5ML	SOLUTION / ORAL	AA	2015-05-12	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203518-002	MORPHINE SULFATE	100MG/5ML	SOLUTION / ORAL	AA	2015-05-12	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203518-001	MORPHINE SULFATE	10MG/5ML	SOLUTION / ORAL	AA	2015-05-12	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A203518-002	MORPHINE SULFATE	100MG/5ML	SOLUTION / ORAL	AA	2015-05-12	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203518-001	MORPHINE SULFATE	10MG/5ML	SOLUTION / ORAL	AA	2015-05-12	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A203518-002	MORPHINE SULFATE	100MG/5ML	SOLUTION / ORAL	AA	2015-05-12	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203518-001	MORPHINE SULFATE	10MG/5ML	SOLUTION / ORAL	AA	2015-05-12	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A203518-002	MORPHINE SULFATE	100MG/5ML	SOLUTION / ORAL	AA	2015-05-12	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203518-001	MORPHINE SULFATE	10MG/5ML	SOLUTION / ORAL	AA	2015-05-12	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A203518-002	MORPHINE SULFATE	100MG/5ML	SOLUTION / ORAL	AA	2015-05-12	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A203518-002	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203518-001	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203518-002	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203518-001	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203518-002	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203518-001	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203518-002	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203518-001	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203518-002	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203518-001	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203518-002	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203518-001	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203518-002	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203518-001	AA	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203518-002	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203518-001	AA	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203518-002	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203518-001	AA	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203518-002	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203518-001	AA	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203518-002	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203518-001	AA	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203518-002	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203518-001	AA	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203518-002	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203518-001	AA	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203518-002	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203518-001	AA	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A203518-002	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203518-001	AA	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203518-002	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203518-001	AA	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A203518-002	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203518-001	AA	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A203518-002	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203518-001	AA	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A203518-002	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203518-001	AA	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A203518-002	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203518-001	AA	1	`782e0a99824c…`

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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Morphine Sulfate	MORPHINE SULFATE	Bryant Ranch Prepack	367d508b-3226-42a9-8dc6-f67cdc9979f3	2026-05-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203518 application number: ANDA203518
Morphine Sulfate	MORPHINE SULFATE	American Health Packaging	5422cdac-8073-41fc-8665-ffe9797f5c02	2026-05-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203518 application number: ANDA203518
Morphine Sulfate	MORPHINE SULFATE	Cranbury Pharmaceuticals, LLC	d8598654-94ad-4cfb-81d2-9b68e013a428	2026-02-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203518 application number: ANDA203518 ndc (product): 27808-084 ndc (product): 27808-082
Morphine Sulfate	MORPHINE SULFATE	Bryant Ranch Prepack	9bb1fef7-4159-4dca-8a8c-37e53ccc6bab	2024-12-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203518 application number: ANDA203518 ndc (product): 63629-2301
Morphine Sulfate	MORPHINE SULFATE	Bryant Ranch Prepack	b7b86b6d-9a39-494c-bf65-f62e4cdc5807	2023-03-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203518 application number: ANDA203518 ndc (product): 63629-2302

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 21 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
27808-082	Morphine Sulfate	Morphine Sulfate	Tris Pharma Inc	ANDA	Current
27808-082	Morphine Sulfate	Morphine Sulfate	Tris Pharma Inc	ANDA	Current
27808-082	Morphine Sulfate	Morphine Sulfate	Tris Pharma Inc	ANDA	Current
27808-082	Morphine Sulfate	Morphine Sulfate	Tris Pharma Inc	ANDA	Current
27808-082	Morphine Sulfate	Morphine Sulfate	Tris Pharma Inc	ANDA	Current
27808-082	Morphine Sulfate	Morphine Sulfate	Tris Pharma Inc	ANDA	Current
27808-082	Morphine Sulfate	Morphine Sulfate	Tris Pharma Inc	ANDA	Current
27808-082	Morphine Sulfate	Morphine Sulfate	Tris Pharma Inc	ANDA	Current
27808-082	Morphine Sulfate	Morphine Sulfate	Tris Pharma Inc	ANDA	Current
27808-082	Morphine Sulfate	Morphine Sulfate	Tris Pharma Inc	ANDA	Current
27808-084	Morphine Sulfate	Morphine Sulfate	Tris Pharma Inc	ANDA	Current
27808-084	Morphine Sulfate	Morphine Sulfate	Tris Pharma Inc	ANDA	Current
27808-084	Morphine Sulfate	Morphine Sulfate	Tris Pharma Inc	ANDA	Current
27808-084	Morphine Sulfate	Morphine Sulfate	Tris Pharma Inc	ANDA	Current
27808-084	Morphine Sulfate	Morphine Sulfate	Tris Pharma Inc	ANDA	Current
63629-2301	Morphine Sulfate	Morphine Sulfate	Bryant Ranch Prepack	ANDA	Current
63629-2301	Morphine Sulfate	Morphine Sulfate	Bryant Ranch Prepack	ANDA	Current
63629-2301	Morphine Sulfate	Morphine Sulfate	Bryant Ranch Prepack	ANDA	Current
63629-2302	Morphine Sulfate	Morphine Sulfate	Bryant Ranch Prepack	ANDA	Current
63629-2302	Morphine Sulfate	Morphine Sulfate	Bryant Ranch Prepack	ANDA	Current
63629-2302	Morphine Sulfate	Morphine Sulfate	Bryant Ranch Prepack	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
76148	ORIG	2023-11-03
32437	ORIG	2015-05-19