Application 074769

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	TABLET, EXTENDED RELEASE;ORAL	100MG	No	No
002	MORPHINE SULFATE	MORPHINE SULFATE	TABLET, EXTENDED RELEASE;ORAL	200MG	No	No

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

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
A074769-001	MORPHINE SULFATE	MORPHINE SULFATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB		1998-07-02
A074769-002	MORPHINE SULFATE	MORPHINE SULFATE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB		1998-07-02

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A074769-001	AB
A074769-002	AB

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 · 82 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
2026-02-19 14:30 UTC	2026-02	A074769-001	MORPHINE SULFATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074769-002	MORPHINE SULFATE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074769-001	MORPHINE SULFATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074769-002	MORPHINE SULFATE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074769-001	MORPHINE SULFATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074769-002	MORPHINE SULFATE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074769-001	MORPHINE SULFATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074769-002	MORPHINE SULFATE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074769-001	MORPHINE SULFATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074769-002	MORPHINE SULFATE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074769-001	MORPHINE SULFATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074769-002	MORPHINE SULFATE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074769-001	MORPHINE SULFATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074769-002	MORPHINE SULFATE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074769-001	MORPHINE SULFATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074769-002	MORPHINE SULFATE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074769-001	MORPHINE SULFATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-02	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074769-002	MORPHINE SULFATE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074769-001	MORPHINE SULFATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-02	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074769-002	MORPHINE SULFATE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074769-001	MORPHINE SULFATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-02	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074769-002	MORPHINE SULFATE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074769-001	MORPHINE SULFATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-02	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074769-002	MORPHINE SULFATE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-02	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074769-001	MORPHINE SULFATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-02	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074769-002	MORPHINE SULFATE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-02	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074769-001	MORPHINE SULFATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-02	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A074769-002	MORPHINE SULFATE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-02	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074769-001	MORPHINE SULFATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-02	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074769-002	MORPHINE SULFATE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-02	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074769-001	MORPHINE SULFATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-02	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A074769-002	MORPHINE SULFATE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-02	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074769-001	MORPHINE SULFATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-02	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A074769-002	MORPHINE SULFATE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-02	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074769-001	MORPHINE SULFATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-02	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A074769-002	MORPHINE SULFATE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-02	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074769-001	MORPHINE SULFATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-02	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A074769-002	MORPHINE SULFATE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-02	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A074769-001	MORPHINE SULFATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-02	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A074769-002	MORPHINE SULFATE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-02	`782e0a99824c…`

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
2026-02-19 14:30 UTC	2026-02	A074769-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074769-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074769-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074769-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074769-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074769-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074769-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074769-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074769-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074769-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074769-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074769-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074769-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074769-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074769-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074769-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074769-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074769-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074769-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074769-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074769-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074769-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074769-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074769-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074769-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074769-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074769-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A074769-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074769-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074769-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074769-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A074769-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074769-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A074769-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074769-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A074769-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074769-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A074769-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A074769-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A074769-002	AB	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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Morphine Sulfate Extended Release	MORPHINE SULFATE	Major Pharmaceuticals	dbb37dfd-0196-45f7-b9ca-393f56cf1d28	2026-05-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074769 application number: ANDA074769 ndc (product): 0904-6560
Morphine Sulfate Extended Release	MORPHINE SULFATE	Rhodes Pharmaceuticals LLC	19c7d9cc-6ce2-4c5c-8c3f-c24fd3342804	2026-05-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074769 application number: ANDA074769 ndc (product): 42858-804 ndc (product): 42858-805
Morphine Sulfate Extended Release	MORPHINE SULFATE	Bryant Ranch Prepack	2dd52157-3121-41ed-abc2-99b269531e56	2026-04-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074769 application number: ANDA074769 ndc (product): 63629-8505
Morphine Sulfate Extended Release	MORPHINE SULFATE	Bryant Ranch Prepack	c94d9da6-7a12-44ee-a38f-3323ee27842c	2026-04-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074769 application number: ANDA074769

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 14 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0904-6560	Morphine Sulfate	Morphine Sulfate	Major Pharmaceuticals	ANDA	Current
0904-6560	Morphine Sulfate	Morphine Sulfate	Major Pharmaceuticals	ANDA	Current
0904-6560	Morphine Sulfate	Morphine Sulfate	Major Pharmaceuticals	ANDA	Current
0904-6560	Morphine Sulfate	Morphine Sulfate	Major Pharmaceuticals	ANDA	Current
42858-804	Morphine Sulfate	Morphine Sulfate	Rhodes Pharmaceuticals L. P.	ANDA	Current
42858-804	Morphine Sulfate	Morphine Sulfate	Rhodes Pharmaceuticals L. P.	ANDA	Current
42858-804	Morphine Sulfate	Morphine Sulfate	Rhodes Pharmaceuticals L. P.	ANDA	Current
42858-805	Morphine Sulfate	Morphine Sulfate	Rhodes Pharmaceuticals L. P.	ANDA	Current
42858-805	Morphine Sulfate	Morphine Sulfate	Rhodes Pharmaceuticals L. P.	ANDA	Current
42858-805	Morphine Sulfate	Morphine Sulfate	Rhodes Pharmaceuticals L. P.	ANDA	Current
63629-4514	morphine sulfate	morphine sulfate	Bryant Ranch Prepack	ANDA	Current
63629-4514	Morphine Sulfate	Morphine Sulfate	Bryant Ranch Prepack	ANDA	Current
63629-8505	Morphine Sulfate	Morphine Sulfate	Bryant Ranch Prepack	ANDA	Current
63629-8505	Morphine Sulfate	Morphine Sulfate	Bryant Ranch Prepack	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
24048	ORIG	2015-06-30
22368	ORIG	1999-03-30
39440	ORIG	1998-07-02
8443	ORIG	1998-07-02