Application 206308

Type: ANDA
Sponsor: RHODES PHARMS

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 43.

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
A206308-001	MORPHINE SULFATE	MORPHINE SULFATE	10MG/5ML	SOLUTION / ORAL			2017-06-22
A206308-002	MORPHINE SULFATE	MORPHINE SULFATE	100MG/5ML	SOLUTION / ORAL			2017-06-22

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 · 86 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
2026-09-14 22:38:34	2026-08	A206308-001	MORPHINE SULFATE	10MG/5ML	SOLUTION / ORAL		2017-06-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A206308-002	MORPHINE SULFATE	100MG/5ML	SOLUTION / ORAL		2017-06-22	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A206308-001	MORPHINE SULFATE	10MG/5ML	SOLUTION / ORAL		2017-06-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206308-002	MORPHINE SULFATE	100MG/5ML	SOLUTION / ORAL		2017-06-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A206308-001	MORPHINE SULFATE	10MG/5ML	SOLUTION / ORAL		2017-06-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206308-002	MORPHINE SULFATE	100MG/5ML	SOLUTION / ORAL		2017-06-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206308-001	MORPHINE SULFATE	10MG/5ML	SOLUTION / ORAL		2017-06-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206308-002	MORPHINE SULFATE	100MG/5ML	SOLUTION / ORAL		2017-06-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206308-001	MORPHINE SULFATE	10MG/5ML	SOLUTION / ORAL		2017-06-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206308-002	MORPHINE SULFATE	100MG/5ML	SOLUTION / ORAL		2017-06-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206308-001	MORPHINE SULFATE	10MG/5ML	SOLUTION / ORAL		2017-06-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206308-002	MORPHINE SULFATE	100MG/5ML	SOLUTION / ORAL		2017-06-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206308-001	MORPHINE SULFATE	10MG/5ML	SOLUTION / ORAL		2017-06-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206308-002	MORPHINE SULFATE	100MG/5ML	SOLUTION / ORAL		2017-06-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206308-001	MORPHINE SULFATE	10MG/5ML	SOLUTION / ORAL	AA	2017-06-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206308-002	MORPHINE SULFATE	100MG/5ML	SOLUTION / ORAL	AA	2017-06-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206308-001	MORPHINE SULFATE	10MG/5ML	SOLUTION / ORAL	AA	2017-06-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206308-002	MORPHINE SULFATE	100MG/5ML	SOLUTION / ORAL	AA	2017-06-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206308-001	MORPHINE SULFATE	10MG/5ML	SOLUTION / ORAL	AA	2017-06-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206308-002	MORPHINE SULFATE	100MG/5ML	SOLUTION / ORAL	AA	2017-06-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206308-001	MORPHINE SULFATE	10MG/5ML	SOLUTION / ORAL	AA	2017-06-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206308-002	MORPHINE SULFATE	100MG/5ML	SOLUTION / ORAL	AA	2017-06-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206308-001	MORPHINE SULFATE	10MG/5ML	SOLUTION / ORAL	AA	2017-06-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206308-002	MORPHINE SULFATE	100MG/5ML	SOLUTION / ORAL	AA	2017-06-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206308-001	MORPHINE SULFATE	10MG/5ML	SOLUTION / ORAL	AA	2017-06-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206308-002	MORPHINE SULFATE	100MG/5ML	SOLUTION / ORAL	AA	2017-06-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206308-001	MORPHINE SULFATE	10MG/5ML	SOLUTION / ORAL	AA	2017-06-22	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206308-002	MORPHINE SULFATE	100MG/5ML	SOLUTION / ORAL	AA	2017-06-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206308-001	MORPHINE SULFATE	10MG/5ML	SOLUTION / ORAL	AA	2017-06-22	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206308-002	MORPHINE SULFATE	100MG/5ML	SOLUTION / ORAL	AA	2017-06-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206308-001	MORPHINE SULFATE	10MG/5ML	SOLUTION / ORAL	AA	2017-06-22	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A206308-002	MORPHINE SULFATE	100MG/5ML	SOLUTION / ORAL	AA	2017-06-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206308-001	MORPHINE SULFATE	10MG/5ML	SOLUTION / ORAL	AA	2017-06-22	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206308-002	MORPHINE SULFATE	100MG/5ML	SOLUTION / ORAL	AA	2017-06-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206308-001	MORPHINE SULFATE	10MG/5ML	SOLUTION / ORAL	AA	2017-06-22	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A206308-002	MORPHINE SULFATE	100MG/5ML	SOLUTION / ORAL	AA	2017-06-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206308-001	MORPHINE SULFATE	10MG/5ML	SOLUTION / ORAL	AA	2017-06-22	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A206308-002	MORPHINE SULFATE	100MG/5ML	SOLUTION / ORAL	AA	2017-06-22	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A206308-001	MORPHINE SULFATE	10MG/5ML	SOLUTION / ORAL	AA	2017-06-22	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A206308-002	MORPHINE SULFATE	100MG/5ML	SOLUTION / ORAL	AA	2017-06-22	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 70 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206308-001	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206308-002	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206308-001	AA	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206308-002	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206308-001	AA	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206308-002	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206308-001	AA	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206308-002	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206308-001	AA	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206308-002	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206308-001	AA	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206308-002	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206308-001	AA	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206308-002	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206308-001	AA	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206308-002	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206308-001	AA	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A206308-002	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206308-001	AA	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206308-002	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206308-001	AA	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A206308-002	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206308-001	AA	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A206308-002	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A206308-001	AA	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A206308-002	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A206308-001	AA	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A206308-002	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A206308-001	AA	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A206308-002	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A206308-001	AA	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A206308-002	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A206308-001	AA	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A206308-002	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A206308-001	AA	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A206308-002	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A206308-001	AA	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A206308-002	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A206308-001	AA	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A206308-002	AA	1	`3f01610625f2…`

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 3 of 4 · 73 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
INFUMORPH 200	MORPHINE SULFATE	Hikma Pharmaceuticals USA Inc.	db9ac9e3-d761-4a99-9f34-4946ebe8f255	2025-12-31	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MORPHINE SULFATE
Morphine Sulfate	MORPHINE SULFATE	Redpharm Drug	300b6afd-bac8-32ca-e063-6294a90a12a7	2025-12-23	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Morphine Sulfate generic name: MORPHINE SULFATE
Morphine Sulfate	MORPHINE SULFATE	Upsher-Smith Laboratories, LLC	5ceb3205-2f8d-4ba3-9f27-dc328bab4fa1	2025-12-23	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Morphine Sulfate generic name: MORPHINE SULFATE
Morphine Sulfate	MORPHINE SULFATE	American Health Packaging	d66d0cfb-9bfe-490c-90ee-49481c567e85	2025-12-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Morphine Sulfate generic name: MORPHINE SULFATE
Morphine Sulfate	MORPHINE SULFATE	Amneal Pharmaceuticals of New York LLC	f7e9a4b3-a2ee-4f0a-becd-6ef90867332b	2025-11-28	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Morphine Sulfate generic name: MORPHINE SULFATE
Morphine Sulfate	MORPHINE SULFATE	American Health Packaging	9f1ba2a2-d8ac-4f59-a587-fe413e56dcdb	2025-11-11	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Morphine Sulfate generic name: MORPHINE SULFATE
MORPHINE SULFATE	MORPHINE SULFATE	Ascend Laboratories, LLC	07593aa4-f2c4-4d6e-b186-ab2a4ecaa38a	2025-10-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: MORPHINE SULFATE generic name: MORPHINE SULFATE
Morphine Sulfate	MORPHINE SULFATE	Nortec Development Associates, Inc.	9c1a5b8b-8faa-4ee0-80bd-853c239bb1c4	2025-08-25	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Morphine Sulfate generic name: MORPHINE SULFATE
Morphine sulfate	MORPHINE SULFATE	Bryant Ranch Prepack	47ea2424-ce2f-4b3b-b393-da1886e7a383	2025-07-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Morphine sulfate generic name: MORPHINE SULFATE
Morphine Sulfate	MORPHINE SULFATE	Civica, Inc.	9362eca1-2bc9-4f72-8895-0b9179bfeb2b	2025-07-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Morphine Sulfate generic name: MORPHINE SULFATE
Morphine Sulfate	MORPHINE SULFATE	Upsher-Smith Laboratories, LLC	97948a8f-7d1b-4614-b11d-e944cf56590b	2025-07-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Morphine Sulfate generic name: MORPHINE SULFATE
MORPHINE SULFATE	MORPHINE SULFATE	Bryant Ranch Prepack	905cd842-2c86-4318-a6c4-92f49de145b3	2025-06-16	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: MORPHINE SULFATE generic name: MORPHINE SULFATE
Morphine Sulfate Extended Release	MORPHINE SULFATE	American Health Packaging	f915420d-981d-455b-b4cf-67c8e201a136	2024-12-30	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MORPHINE SULFATE
Morphine Sulfate	MORPHINE SULFATE	International Medication Systems, Limited	1034467f-d436-4b87-a902-c7e8885daa8a	2024-12-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Morphine Sulfate generic name: MORPHINE SULFATE
Morphine Sulfate	MORPHINE SULFATE	Bryant Ranch Prepack	9bb1fef7-4159-4dca-8a8c-37e53ccc6bab	2024-12-06	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Morphine Sulfate generic name: MORPHINE SULFATE
Morphine Sulfate	MORPHINE SULFATE	PAI Holdings, LLC dba PAI Pharma	6e32b869-31c7-48c1-98ae-b21bd28151d7	2024-11-19	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Morphine Sulfate generic name: MORPHINE SULFATE
Morphine sulfate	MORPHINE SULFATE	Bryant Ranch Prepack	2f15f27b-95ed-4cc8-8937-eae07917a6dd	2024-08-22	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Morphine sulfate generic name: MORPHINE SULFATE
Morphine sulfate	MORPHINE SULFATE	Bryant Ranch Prepack	20af0f0e-45cc-4795-97ef-90b659575b34	2024-08-20	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Morphine sulfate generic name: MORPHINE SULFATE
Morphine sulfate	MORPHINE SULFATE	Bryant Ranch Prepack	3e310662-16e8-4179-883e-efbca736b14d	2024-08-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Morphine sulfate generic name: MORPHINE SULFATE
Morphine sulfate	MORPHINE SULFATE	Bryant Ranch Prepack	7f65fa22-c3fc-4413-8a07-2c6be621b7bf	2024-07-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Morphine sulfate generic name: MORPHINE SULFATE

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 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
42858-810	Morphine Sulfate	Morphine Sulfate	Rhodes Pharmaceuticals L.P.	ANDA	Current
42858-810	Morphine Sulfate	Morphine Sulfate	Rhodes Pharmaceuticals L.P.	ANDA	Current
42858-810	Morphine Sulfate	Morphine Sulfate	Rhodes Pharmaceuticals L.P.	ANDA	Current
42858-812	Morphine Sulfate	Morphine Sulfate	Rhodes Pharmaceuticals L.P.	ANDA	Current
42858-812	Morphine Sulfate	Morphine Sulfate	Rhodes Pharmaceuticals L.P.	ANDA	Current
42858-812	Morphine Sulfate	Morphine Sulfate	Rhodes Pharmaceuticals L.P.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
76161	ORIG	2023-11-03
48828	ORIG	2017-06-26