Application 019516

Type: NDA
Sponsor: PURDUE PHARMA LP

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	MS CONTIN	MORPHINE SULFATE	TABLET, EXTENDED RELEASE;ORAL	30MG	Yes	No
002	MS CONTIN	MORPHINE SULFATE	TABLET, EXTENDED RELEASE;ORAL	60MG	Yes	No
003	MS CONTIN	MORPHINE SULFATE	TABLET, EXTENDED RELEASE;ORAL	15MG	Yes	No
004	MS CONTIN	MORPHINE SULFATE	TABLET, EXTENDED RELEASE;ORAL	100MG	Yes	Yes
005	MS CONTIN	MORPHINE SULFATE	TABLET, EXTENDED RELEASE;ORAL	200MG	Yes	No

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

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N019516-001	MS CONTIN	MORPHINE SULFATE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1987-05-29
N019516-002	MS CONTIN	MORPHINE SULFATE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1988-04-08
N019516-003	MS CONTIN	MORPHINE SULFATE	15MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1989-09-12
N019516-004	MS CONTIN	MORPHINE SULFATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	1990-01-16
N019516-005	MS CONTIN	MORPHINE SULFATE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1993-11-08

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 5 matching rows.

Application-product, TE code table
Application-product	TE code
N019516-001	AB
N019516-002	AB
N019516-003	AB
N019516-004	AB
N019516-005	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 6 · 210 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
2026-08-18 06:07:40	2026-07	N019516-001	MS CONTIN	30MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1987-05-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019516-002	MS CONTIN	60MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1988-04-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019516-003	MS CONTIN	15MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1989-09-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019516-004	MS CONTIN	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	1990-01-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019516-005	MS CONTIN	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1993-11-08	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N019516-001	MS CONTIN	30MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1987-05-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019516-002	MS CONTIN	60MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1988-04-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019516-003	MS CONTIN	15MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1989-09-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019516-004	MS CONTIN	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	1990-01-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019516-005	MS CONTIN	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1993-11-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019516-001	MS CONTIN	30MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1987-05-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019516-002	MS CONTIN	60MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1988-04-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019516-003	MS CONTIN	15MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1989-09-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019516-004	MS CONTIN	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	1990-01-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019516-005	MS CONTIN	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1993-11-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019516-001	MS CONTIN	30MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1987-05-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019516-002	MS CONTIN	60MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1988-04-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019516-003	MS CONTIN	15MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1989-09-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019516-004	MS CONTIN	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	1990-01-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019516-005	MS CONTIN	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1993-11-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019516-001	MS CONTIN	30MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1987-05-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019516-002	MS CONTIN	60MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1988-04-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019516-003	MS CONTIN	15MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1989-09-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019516-004	MS CONTIN	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	1990-01-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019516-005	MS CONTIN	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1993-11-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019516-001	MS CONTIN	30MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1987-05-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019516-002	MS CONTIN	60MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1988-04-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019516-003	MS CONTIN	15MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1989-09-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019516-004	MS CONTIN	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	1990-01-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019516-005	MS CONTIN	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1993-11-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019516-001	MS CONTIN	30MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1987-05-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019516-002	MS CONTIN	60MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1988-04-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019516-003	MS CONTIN	15MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1989-09-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019516-004	MS CONTIN	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	1990-01-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019516-005	MS CONTIN	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1993-11-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019516-001	MS CONTIN	30MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1987-05-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019516-002	MS CONTIN	60MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1988-04-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019516-003	MS CONTIN	15MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1989-09-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019516-004	MS CONTIN	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	1990-01-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019516-005	MS CONTIN	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1993-11-08	`2680178bc6a6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 210 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	N019516-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019516-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019516-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019516-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019516-005	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N019516-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019516-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019516-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019516-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019516-005	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019516-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019516-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019516-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019516-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019516-005	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019516-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019516-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019516-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019516-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019516-005	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019516-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019516-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019516-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019516-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019516-005	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019516-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019516-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019516-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019516-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019516-005	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019516-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019516-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019516-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019516-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019516-005	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019516-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019516-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019516-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019516-004	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019516-005	AB	1	`2680178bc6a6…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
MS Contin	MORPHINE SULFATE	Rhodes Pharmaceuticals LLC	c354b3bf-86c0-4bb8-8b1f-be2164942698	2026-05-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 019516 application number: NDA019516 ndc (product): 42858-799 ndc (product): 42858-900 ndc (product): 42858-760 ndc (product): 42858-631 ndc (product): 42858-515

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 25 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
42858-515	MS Contin	morphine sulfate	Rhodes Pharmaceuticals L.P.	NDA	Current
42858-515	MS Contin	morphine sulfate	Rhodes Pharmaceuticals L.P.	NDA	Current
42858-515	MS Contin	morphine sulfate	Rhodes Pharmaceuticals L.P.	NDA	Current
42858-515	MS Contin	morphine sulfate	Rhodes Pharmaceuticals L.P.	NDA	Current
42858-631	MS Contin	morphine sulfate	Rhodes Pharmaceuticals L.P.	NDA	Current
42858-631	MS Contin	morphine sulfate	Rhodes Pharmaceuticals L.P.	NDA	Current
42858-631	MS Contin	morphine sulfate	Rhodes Pharmaceuticals L.P.	NDA	Current
42858-631	MS Contin	morphine sulfate	Rhodes Pharmaceuticals L.P.	NDA	Current
42858-760	MS Contin	morphine sulfate	Rhodes Pharmaceuticals L.P.	NDA	Current
42858-760	MS Contin	morphine sulfate	Rhodes Pharmaceuticals L.P.	NDA	Current
42858-760	MS Contin	morphine sulfate	Rhodes Pharmaceuticals L.P.	NDA	Current
42858-760	MS Contin	morphine sulfate	Rhodes Pharmaceuticals L.P.	NDA	Current
42858-799	MS Contin	morphine sulfate	Rhodes Pharmaceuticals L.P.	NDA	Current
42858-799	MS Contin	morphine sulfate	Rhodes Pharmaceuticals L.P.	NDA	Current
42858-799	MS Contin	morphine sulfate	Rhodes Pharmaceuticals L.P.	NDA	Current
42858-799	MS Contin	morphine sulfate	Rhodes Pharmaceuticals L.P.	NDA	Current
42858-900	MS Contin	morphine sulfate	Rhodes Pharmaceuticals L.P.	NDA	Current
42858-900	MS Contin	morphine sulfate	Rhodes Pharmaceuticals L.P.	NDA	Current
42858-900	MS Contin	morphine sulfate	Rhodes Pharmaceuticals L.P.	NDA	Current
42858-900	MS Contin	morphine sulfate	Rhodes Pharmaceuticals L.P.	NDA	Current
59011-260	MS Contin	morphine sulfate	Purdue Pharma LP	NDA	Current
59011-261	MS Contin	morphine sulfate	Purdue Pharma LP	NDA	Current
59011-262	MS Contin	morphine sulfate	Purdue Pharma LP	NDA	Current
59011-263	MS Contin	morphine sulfate	Purdue Pharma LP	NDA	Current
59011-264	MS Contin	morphine sulfate	Purdue Pharma LP	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
84712	SUPPL	2026-01-07
84711	SUPPL	2026-01-07
84563	SUPPL	2025-12-29
80088	SUPPL	2024-11-04
76993	SUPPL	2023-12-19
76890	SUPPL	2023-12-18
66525	SUPPL	2021-03-05
66522	SUPPL	2021-03-05
66521	SUPPL	2021-03-05
60321	SUPPL	2019-10-08
60312	SUPPL	2019-10-08
60311	SUPPL	2019-10-08
55835	SUPPL	2018-10-05
55834	SUPPL	2018-10-05
55651	SUPPL	2018-09-28
55650	SUPPL	2018-09-28
48580	SUPPL	2017-05-31
46395	SUPPL	2016-12-21
46236	SUPPL	2016-12-20
45459	SUPPL	2016-10-04
1359	SUPPL	2016-04-22
17428	SUPPL	2015-06-29
33771	SUPPL	2014-10-30
1357	SUPPL	2014-10-30
1358	SUPPL	2014-08-20
17427	SUPPL	2014-04-17
33770	SUPPL	2014-04-16
17426	SUPPL	2013-04-16
33769	SUPPL	2012-07-13
33768	SUPPL	2012-07-12
23962	ORIG	2012-07-11
17425	SUPPL	2012-07-11
1356	SUPPL	2012-07-11
33767	SUPPL	2010-05-17
1355	SUPPL	2010-05-14
1354	SUPPL	2007-05-29
1353	SUPPL	2004-06-09
17424	SUPPL	2003-08-14