Application 200411

Type: ANDA
Sponsor: IMPAX LABS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	MORPHINE SULFATE	MORPHINE SULFATE	CAPSULE, EXTENDED RELEASE;ORAL	20MG	No	No
002	MORPHINE SULFATE	MORPHINE SULFATE	CAPSULE, EXTENDED RELEASE;ORAL	30MG	No	No
003	MORPHINE SULFATE	MORPHINE SULFATE	CAPSULE, EXTENDED RELEASE;ORAL	50MG	No	No
004	MORPHINE SULFATE	MORPHINE SULFATE	CAPSULE, EXTENDED RELEASE;ORAL	60MG	No	No
005	MORPHINE SULFATE	MORPHINE SULFATE	CAPSULE, EXTENDED RELEASE;ORAL	80MG	No	No
006	MORPHINE SULFATE	MORPHINE SULFATE	CAPSULE, EXTENDED RELEASE;ORAL	100MG	No	No
007	MORPHINE SULFATE	MORPHINE SULFATE	CAPSULE, EXTENDED RELEASE;ORAL	40MG	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 7 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A200411-001	MORPHINE SULFATE	MORPHINE SULFATE	20MG	CAPSULE, EXTENDED RELEASE / ORAL	2016-04-12
A200411-002	MORPHINE SULFATE	MORPHINE SULFATE	30MG	CAPSULE, EXTENDED RELEASE / ORAL	2016-04-12
A200411-003	MORPHINE SULFATE	MORPHINE SULFATE	50MG	CAPSULE, EXTENDED RELEASE / ORAL	2016-04-12
A200411-004	MORPHINE SULFATE	MORPHINE SULFATE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	2016-04-12
A200411-005	MORPHINE SULFATE	MORPHINE SULFATE	80MG	CAPSULE, EXTENDED RELEASE / ORAL	2016-04-12
A200411-006	MORPHINE SULFATE	MORPHINE SULFATE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	2016-04-12
A200411-007	MORPHINE SULFATE	MORPHINE SULFATE	40MG	CAPSULE, EXTENDED RELEASE / ORAL	2018-07-25

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 8 · 284 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A200411-001	MORPHINE SULFATE	20MG	CAPSULE, EXTENDED RELEASE / ORAL	2016-04-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200411-002	MORPHINE SULFATE	30MG	CAPSULE, EXTENDED RELEASE / ORAL	2016-04-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200411-003	MORPHINE SULFATE	50MG	CAPSULE, EXTENDED RELEASE / ORAL	2016-04-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200411-004	MORPHINE SULFATE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	2016-04-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200411-005	MORPHINE SULFATE	80MG	CAPSULE, EXTENDED RELEASE / ORAL	2016-04-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200411-006	MORPHINE SULFATE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	2016-04-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200411-007	MORPHINE SULFATE	40MG	CAPSULE, EXTENDED RELEASE / ORAL	2018-07-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200411-001	MORPHINE SULFATE	20MG	CAPSULE, EXTENDED RELEASE / ORAL	2016-04-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200411-002	MORPHINE SULFATE	30MG	CAPSULE, EXTENDED RELEASE / ORAL	2016-04-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200411-003	MORPHINE SULFATE	50MG	CAPSULE, EXTENDED RELEASE / ORAL	2016-04-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200411-004	MORPHINE SULFATE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	2016-04-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200411-005	MORPHINE SULFATE	80MG	CAPSULE, EXTENDED RELEASE / ORAL	2016-04-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200411-006	MORPHINE SULFATE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	2016-04-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200411-007	MORPHINE SULFATE	40MG	CAPSULE, EXTENDED RELEASE / ORAL	2018-07-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A200411-001	MORPHINE SULFATE	20MG	CAPSULE, EXTENDED RELEASE / ORAL	2016-04-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200411-002	MORPHINE SULFATE	30MG	CAPSULE, EXTENDED RELEASE / ORAL	2016-04-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200411-003	MORPHINE SULFATE	50MG	CAPSULE, EXTENDED RELEASE / ORAL	2016-04-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200411-004	MORPHINE SULFATE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	2016-04-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200411-005	MORPHINE SULFATE	80MG	CAPSULE, EXTENDED RELEASE / ORAL	2016-04-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200411-006	MORPHINE SULFATE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	2016-04-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200411-007	MORPHINE SULFATE	40MG	CAPSULE, EXTENDED RELEASE / ORAL	2018-07-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200411-001	MORPHINE SULFATE	20MG	CAPSULE, EXTENDED RELEASE / ORAL	2016-04-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200411-002	MORPHINE SULFATE	30MG	CAPSULE, EXTENDED RELEASE / ORAL	2016-04-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200411-003	MORPHINE SULFATE	50MG	CAPSULE, EXTENDED RELEASE / ORAL	2016-04-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200411-004	MORPHINE SULFATE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	2016-04-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200411-005	MORPHINE SULFATE	80MG	CAPSULE, EXTENDED RELEASE / ORAL	2016-04-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200411-006	MORPHINE SULFATE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	2016-04-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200411-007	MORPHINE SULFATE	40MG	CAPSULE, EXTENDED RELEASE / ORAL	2018-07-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200411-001	MORPHINE SULFATE	20MG	CAPSULE, EXTENDED RELEASE / ORAL	2016-04-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200411-002	MORPHINE SULFATE	30MG	CAPSULE, EXTENDED RELEASE / ORAL	2016-04-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200411-003	MORPHINE SULFATE	50MG	CAPSULE, EXTENDED RELEASE / ORAL	2016-04-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200411-004	MORPHINE SULFATE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	2016-04-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200411-005	MORPHINE SULFATE	80MG	CAPSULE, EXTENDED RELEASE / ORAL	2016-04-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200411-006	MORPHINE SULFATE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	2016-04-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200411-007	MORPHINE SULFATE	40MG	CAPSULE, EXTENDED RELEASE / ORAL	2018-07-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200411-001	MORPHINE SULFATE	20MG	CAPSULE, EXTENDED RELEASE / ORAL	2016-04-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200411-002	MORPHINE SULFATE	30MG	CAPSULE, EXTENDED RELEASE / ORAL	2016-04-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200411-003	MORPHINE SULFATE	50MG	CAPSULE, EXTENDED RELEASE / ORAL	2016-04-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200411-004	MORPHINE SULFATE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	2016-04-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200411-005	MORPHINE SULFATE	80MG	CAPSULE, EXTENDED RELEASE / ORAL	2016-04-12	`03ed91905a0d…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 89 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200411-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200411-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200411-003	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200411-004	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200411-005	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200411-006	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A200411-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A200411-002	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A200411-003	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A200411-004	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A200411-005	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A200411-006	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A200411-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A200411-002	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A200411-003	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A200411-004	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A200411-005	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A200411-006	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A200411-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A200411-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A200411-003	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A200411-004	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A200411-005	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A200411-006	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A200411-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A200411-002	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A200411-003	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A200411-004	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A200411-005	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A200411-006	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A200411-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A200411-002	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A200411-003	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A200411-004	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A200411-005	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A200411-006	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A200411-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A200411-002	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A200411-003	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A200411-004	AB	1	`87673890dc5c…`

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
Morphine Sulfate	MORPHINE SULFATE	Amneal Pharmaceuticals of New York LLC	f7e9a4b3-a2ee-4f0a-becd-6ef90867332b	2025-11-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200411 application number: ANDA200411 ndc (product): 0115-1277 ndc (product): 0115-1279 ndc (product): 0115-1278 ndc (product): 0115-1280 ndc (product): 0115-1282 ndc (product): 0115-1479 ndc (product): 0115-1281

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 42 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0115-1277	Morphine Sulfate	MORPHINE SULFATE	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-1277	Morphine Sulfate	MORPHINE SULFATE	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-1277	Morphine Sulfate	MORPHINE SULFATE	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-1277	Morphine Sulfate	MORPHINE SULFATE	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-1277	Morphine Sulfate	MORPHINE SULFATE	Impax Generics	ANDA	Current
0115-1277	Morphine Sulfate	MORPHINE SULFATE	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-1278	Morphine Sulfate	MORPHINE SULFATE	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-1278	Morphine Sulfate	MORPHINE SULFATE	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-1278	Morphine Sulfate	MORPHINE SULFATE	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-1278	Morphine Sulfate	MORPHINE SULFATE	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-1278	Morphine Sulfate	MORPHINE SULFATE	Impax Generics	ANDA	Current
0115-1278	Morphine Sulfate	MORPHINE SULFATE	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-1279	Morphine Sulfate	MORPHINE SULFATE	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-1279	Morphine Sulfate	MORPHINE SULFATE	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-1279	Morphine Sulfate	MORPHINE SULFATE	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-1279	Morphine Sulfate	MORPHINE SULFATE	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-1279	Morphine Sulfate	MORPHINE SULFATE	Impax Generics	ANDA	Current
0115-1279	Morphine Sulfate	MORPHINE SULFATE	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-1280	Morphine Sulfate	MORPHINE SULFATE	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-1280	Morphine Sulfate	MORPHINE SULFATE	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-1280	Morphine Sulfate	MORPHINE SULFATE	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-1280	Morphine Sulfate	MORPHINE SULFATE	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-1280	Morphine Sulfate	MORPHINE SULFATE	Impax Generics	ANDA	Current
0115-1280	Morphine Sulfate	MORPHINE SULFATE	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-1281	Morphine Sulfate	MORPHINE SULFATE	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-1281	Morphine Sulfate	MORPHINE SULFATE	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-1281	Morphine Sulfate	MORPHINE SULFATE	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-1281	Morphine Sulfate	MORPHINE SULFATE	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-1281	Morphine Sulfate	MORPHINE SULFATE	Impax Generics	ANDA	Current
0115-1281	Morphine Sulfate	MORPHINE SULFATE	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-1282	Morphine Sulfate	MORPHINE SULFATE	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-1282	Morphine Sulfate	MORPHINE SULFATE	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-1282	Morphine Sulfate	MORPHINE SULFATE	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-1282	Morphine Sulfate	MORPHINE SULFATE	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-1282	Morphine Sulfate	MORPHINE SULFATE	Impax Generics	ANDA	Current
0115-1282	Morphine Sulfate	MORPHINE SULFATE	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-1479	Morphine Sulfate	MORPHINE SULFATE	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-1479	Morphine Sulfate	MORPHINE SULFATE	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-1479	Morphine Sulfate	MORPHINE SULFATE	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-1479	Morphine Sulfate	MORPHINE SULFATE	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-1479	Morphine Sulfate	MORPHINE SULFATE	Impax Generics	ANDA	Current
0115-1479	Morphine Sulfate	MORPHINE SULFATE	Amneal Pharmaceuticals of New York LLC	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
24094	ORIG	2016-04-18