Application 202104

Type: ANDA
Sponsor: UPSHER SMITH LABS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	MORPHINE SULFATE	MORPHINE SULFATE	CAPSULE, EXTENDED RELEASE;ORAL	10MG	No	No
002	MORPHINE SULFATE	MORPHINE SULFATE	CAPSULE, EXTENDED RELEASE;ORAL	20MG	No	No
003	MORPHINE SULFATE	MORPHINE SULFATE	CAPSULE, EXTENDED RELEASE;ORAL	30MG	No	No
004	MORPHINE SULFATE	MORPHINE SULFATE	CAPSULE, EXTENDED RELEASE;ORAL	50MG	No	No
005	MORPHINE SULFATE	MORPHINE SULFATE	CAPSULE, EXTENDED RELEASE;ORAL	60MG	No	No
006	MORPHINE SULFATE	MORPHINE SULFATE	CAPSULE, EXTENDED RELEASE;ORAL	80MG	No	No
007	MORPHINE SULFATE	MORPHINE SULFATE	CAPSULE, EXTENDED RELEASE;ORAL	100MG	No	No

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

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	RLD / RS	Approval date
A202104-001	MORPHINE SULFATE	MORPHINE SULFATE	10MG	CAPSULE, EXTENDED RELEASE / ORAL		2013-06-03
A202104-002	MORPHINE SULFATE	MORPHINE SULFATE	20MG	CAPSULE, EXTENDED RELEASE / ORAL		2013-06-03
A202104-003	MORPHINE SULFATE	MORPHINE SULFATE	30MG	CAPSULE, EXTENDED RELEASE / ORAL		2013-06-03
A202104-004	MORPHINE SULFATE	MORPHINE SULFATE	50MG	CAPSULE, EXTENDED RELEASE / ORAL		2013-06-03
A202104-005	MORPHINE SULFATE	MORPHINE SULFATE	60MG	CAPSULE, EXTENDED RELEASE / ORAL		2013-06-03
A202104-006	MORPHINE SULFATE	MORPHINE SULFATE	80MG	CAPSULE, EXTENDED RELEASE / ORAL		2013-06-03
A202104-007	MORPHINE SULFATE	MORPHINE SULFATE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	RS	2013-06-03

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 · 294 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A202104-001	MORPHINE SULFATE	10MG	CAPSULE, EXTENDED RELEASE / ORAL		2013-06-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202104-002	MORPHINE SULFATE	20MG	CAPSULE, EXTENDED RELEASE / ORAL		2013-06-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202104-003	MORPHINE SULFATE	30MG	CAPSULE, EXTENDED RELEASE / ORAL		2013-06-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202104-004	MORPHINE SULFATE	50MG	CAPSULE, EXTENDED RELEASE / ORAL		2013-06-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202104-005	MORPHINE SULFATE	60MG	CAPSULE, EXTENDED RELEASE / ORAL		2013-06-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202104-006	MORPHINE SULFATE	80MG	CAPSULE, EXTENDED RELEASE / ORAL		2013-06-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202104-007	MORPHINE SULFATE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	RS	2013-06-03	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202104-001	MORPHINE SULFATE	10MG	CAPSULE, EXTENDED RELEASE / ORAL		2013-06-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202104-002	MORPHINE SULFATE	20MG	CAPSULE, EXTENDED RELEASE / ORAL		2013-06-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202104-003	MORPHINE SULFATE	30MG	CAPSULE, EXTENDED RELEASE / ORAL		2013-06-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202104-004	MORPHINE SULFATE	50MG	CAPSULE, EXTENDED RELEASE / ORAL		2013-06-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202104-005	MORPHINE SULFATE	60MG	CAPSULE, EXTENDED RELEASE / ORAL		2013-06-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202104-006	MORPHINE SULFATE	80MG	CAPSULE, EXTENDED RELEASE / ORAL		2013-06-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202104-007	MORPHINE SULFATE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	RS	2013-06-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202104-001	MORPHINE SULFATE	10MG	CAPSULE, EXTENDED RELEASE / ORAL		2013-06-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202104-002	MORPHINE SULFATE	20MG	CAPSULE, EXTENDED RELEASE / ORAL		2013-06-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202104-003	MORPHINE SULFATE	30MG	CAPSULE, EXTENDED RELEASE / ORAL		2013-06-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202104-004	MORPHINE SULFATE	50MG	CAPSULE, EXTENDED RELEASE / ORAL		2013-06-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202104-005	MORPHINE SULFATE	60MG	CAPSULE, EXTENDED RELEASE / ORAL		2013-06-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202104-006	MORPHINE SULFATE	80MG	CAPSULE, EXTENDED RELEASE / ORAL		2013-06-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202104-007	MORPHINE SULFATE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	RS	2013-06-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202104-001	MORPHINE SULFATE	10MG	CAPSULE, EXTENDED RELEASE / ORAL		2013-06-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202104-002	MORPHINE SULFATE	20MG	CAPSULE, EXTENDED RELEASE / ORAL		2013-06-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202104-003	MORPHINE SULFATE	30MG	CAPSULE, EXTENDED RELEASE / ORAL		2013-06-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202104-004	MORPHINE SULFATE	50MG	CAPSULE, EXTENDED RELEASE / ORAL		2013-06-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202104-005	MORPHINE SULFATE	60MG	CAPSULE, EXTENDED RELEASE / ORAL		2013-06-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202104-006	MORPHINE SULFATE	80MG	CAPSULE, EXTENDED RELEASE / ORAL		2013-06-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202104-007	MORPHINE SULFATE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	RS	2013-06-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202104-001	MORPHINE SULFATE	10MG	CAPSULE, EXTENDED RELEASE / ORAL		2013-06-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202104-002	MORPHINE SULFATE	20MG	CAPSULE, EXTENDED RELEASE / ORAL		2013-06-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202104-003	MORPHINE SULFATE	30MG	CAPSULE, EXTENDED RELEASE / ORAL		2013-06-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202104-004	MORPHINE SULFATE	50MG	CAPSULE, EXTENDED RELEASE / ORAL		2013-06-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202104-005	MORPHINE SULFATE	60MG	CAPSULE, EXTENDED RELEASE / ORAL		2013-06-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202104-006	MORPHINE SULFATE	80MG	CAPSULE, EXTENDED RELEASE / ORAL		2013-06-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202104-007	MORPHINE SULFATE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	RS	2013-06-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202104-001	MORPHINE SULFATE	10MG	CAPSULE, EXTENDED RELEASE / ORAL		2013-06-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202104-002	MORPHINE SULFATE	20MG	CAPSULE, EXTENDED RELEASE / ORAL		2013-06-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202104-003	MORPHINE SULFATE	30MG	CAPSULE, EXTENDED RELEASE / ORAL		2013-06-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202104-004	MORPHINE SULFATE	50MG	CAPSULE, EXTENDED RELEASE / ORAL		2013-06-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202104-005	MORPHINE SULFATE	60MG	CAPSULE, EXTENDED RELEASE / ORAL		2013-06-03	`b8a1b40f171c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 92 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	A202104-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202104-003	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202104-004	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202104-005	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202104-006	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202104-007	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202104-002	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A202104-003	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A202104-004	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A202104-005	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A202104-006	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A202104-007	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202104-002	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A202104-003	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A202104-004	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A202104-005	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A202104-006	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A202104-007	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202104-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A202104-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A202104-003	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A202104-004	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A202104-005	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A202104-006	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A202104-007	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202104-002	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A202104-003	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A202104-004	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A202104-005	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A202104-006	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A202104-007	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202104-002	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A202104-003	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A202104-004	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A202104-005	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A202104-006	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A202104-007	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202104-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202104-002	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202104-003	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	Upsher-Smith Laboratories, LLC	97948a8f-7d1b-4614-b11d-e944cf56590b	2025-07-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202104 application number: ANDA202104 ndc (product): 0832-0229 ndc (product): 0832-0226 ndc (product): 0832-0233 ndc (product): 0832-0228 ndc (product): 0832-0230 ndc (product): 0832-0227 ndc (product): 0832-0225

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 31 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0832-0225	Morphine Sulfate	Morphine Sulfate	Upsher-Smith Laboratories, LLC	ANDA	Current
0832-0225	Morphine Sulfate	Morphine Sulfate	Upsher-Smith Laboratories, LLC	ANDA	Current
0832-0225	Morphine Sulfate	Morphine Sulfate	Upsher-Smith Laboratories, LLC	ANDA	Current
0832-0226	Morphine Sulfate	Morphine Sulfate	Upsher-Smith Laboratories, LLC	ANDA	Current
0832-0226	Morphine Sulfate	Morphine Sulfate	Upsher-Smith Laboratories, LLC	ANDA	Current
0832-0226	Morphine Sulfate	Morphine Sulfate	Upsher-Smith Laboratories, LLC	ANDA	Current
0832-0227	Morphine Sulfate	Morphine Sulfate	Upsher-Smith Laboratories, LLC	ANDA	Current
0832-0227	Morphine Sulfate	Morphine Sulfate	Upsher-Smith Laboratories, LLC	ANDA	Current
0832-0227	Morphine Sulfate	Morphine Sulfate	Upsher-Smith Laboratories, LLC	ANDA	Current
0832-0228	Morphine Sulfate	Morphine Sulfate	Upsher-Smith Laboratories, LLC	ANDA	Current
0832-0228	Morphine Sulfate	Morphine Sulfate	Upsher-Smith Laboratories, LLC	ANDA	Current
0832-0228	Morphine Sulfate	Morphine Sulfate	Upsher-Smith Laboratories, LLC	ANDA	Current
0832-0229	Morphine Sulfate	Morphine Sulfate	Upsher-Smith Laboratories, LLC	ANDA	Current
0832-0229	Morphine Sulfate	Morphine Sulfate	Upsher-Smith Laboratories, LLC	ANDA	Current
0832-0229	Morphine Sulfate	Morphine Sulfate	Upsher-Smith Laboratories, LLC	ANDA	Current
0832-0230	Morphine Sulfate	Morphine Sulfate	Upsher-Smith Laboratories, LLC	ANDA	Current
0832-0230	Morphine Sulfate	Morphine Sulfate	Upsher-Smith Laboratories, LLC	ANDA	Current
0832-0230	Morphine Sulfate	Morphine Sulfate	Upsher-Smith Laboratories, LLC	ANDA	Current
0832-0233	Morphine Sulfate	Morphine Sulfate	Upsher-Smith Laboratories, LLC	ANDA	Current
0832-0233	Morphine Sulfate	Morphine Sulfate	Upsher-Smith Laboratories, LLC	ANDA	Current
0832-0233	Morphine Sulfate	Morphine Sulfate	Upsher-Smith Laboratories, LLC	ANDA	Current
55700-349	Morphine Sulfate	Morphine Sulfate	Quality Care Products LLC	ANDA	Current
55700-349	Morphine Sulfate	Morphine Sulfate	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-349	Morphine Sulfate	Morphine Sulfate	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-349	Morphine Sulfate	Morphine Sulfate	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-349	Morphine Sulfate	Morphine Sulfate	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-349	Morphine Sulfate	Morphine Sulfate	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-350	Morphine Sulfate	Morphine Sulfate	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-350	Morphine Sulfate	Morphine Sulfate	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-552	Morphine Sulfate	Morphine Sulfate	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-552	Morphine Sulfate	Morphine Sulfate	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
24099	ORIG	2015-06-30