Application 079040

Type: ANDA
Sponsor: ACTAVIS ELIZABETH

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	MORPHINE SULFATE	MORPHINE SULFATE	CAPSULE, EXTENDED RELEASE;ORAL	30MG	No	No
002	MORPHINE SULFATE	MORPHINE SULFATE	CAPSULE, EXTENDED RELEASE;ORAL	45MG	No	No
003	MORPHINE SULFATE	MORPHINE SULFATE	CAPSULE, EXTENDED RELEASE;ORAL	60MG	No	No
004	MORPHINE SULFATE	MORPHINE SULFATE	CAPSULE, EXTENDED RELEASE;ORAL	75MG	No	No
005	MORPHINE SULFATE	MORPHINE SULFATE	CAPSULE, EXTENDED RELEASE;ORAL	90MG	No	No
006	MORPHINE SULFATE	MORPHINE SULFATE	CAPSULE, EXTENDED RELEASE;ORAL	120MG	No	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
A079040-001	MORPHINE SULFATE	MORPHINE SULFATE	30MG	CAPSULE, EXTENDED RELEASE / ORAL		2013-01-16
A079040-002	MORPHINE SULFATE	MORPHINE SULFATE	45MG	CAPSULE, EXTENDED RELEASE / ORAL		2013-01-16
A079040-003	MORPHINE SULFATE	MORPHINE SULFATE	60MG	CAPSULE, EXTENDED RELEASE / ORAL		2013-01-16
A079040-004	MORPHINE SULFATE	MORPHINE SULFATE	75MG	CAPSULE, EXTENDED RELEASE / ORAL		2013-01-16
A079040-005	MORPHINE SULFATE	MORPHINE SULFATE	90MG	CAPSULE, EXTENDED RELEASE / ORAL		2013-01-16
A079040-006	MORPHINE SULFATE	MORPHINE SULFATE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	RS	2013-01-16

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 7 · 264 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	A079040-001	MORPHINE SULFATE	30MG	CAPSULE, EXTENDED RELEASE / ORAL		2013-01-16	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A079040-002	MORPHINE SULFATE	45MG	CAPSULE, EXTENDED RELEASE / ORAL		2013-01-16	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A079040-003	MORPHINE SULFATE	60MG	CAPSULE, EXTENDED RELEASE / ORAL		2013-01-16	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A079040-004	MORPHINE SULFATE	75MG	CAPSULE, EXTENDED RELEASE / ORAL		2013-01-16	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A079040-005	MORPHINE SULFATE	90MG	CAPSULE, EXTENDED RELEASE / ORAL		2013-01-16	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A079040-006	MORPHINE SULFATE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	RS	2013-01-16	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A079040-001	MORPHINE SULFATE	30MG	CAPSULE, EXTENDED RELEASE / ORAL		2013-01-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A079040-002	MORPHINE SULFATE	45MG	CAPSULE, EXTENDED RELEASE / ORAL		2013-01-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A079040-003	MORPHINE SULFATE	60MG	CAPSULE, EXTENDED RELEASE / ORAL		2013-01-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A079040-004	MORPHINE SULFATE	75MG	CAPSULE, EXTENDED RELEASE / ORAL		2013-01-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A079040-005	MORPHINE SULFATE	90MG	CAPSULE, EXTENDED RELEASE / ORAL		2013-01-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A079040-006	MORPHINE SULFATE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	RS	2013-01-16	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A079040-001	MORPHINE SULFATE	30MG	CAPSULE, EXTENDED RELEASE / ORAL		2013-01-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A079040-002	MORPHINE SULFATE	45MG	CAPSULE, EXTENDED RELEASE / ORAL		2013-01-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A079040-003	MORPHINE SULFATE	60MG	CAPSULE, EXTENDED RELEASE / ORAL		2013-01-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A079040-004	MORPHINE SULFATE	75MG	CAPSULE, EXTENDED RELEASE / ORAL		2013-01-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A079040-005	MORPHINE SULFATE	90MG	CAPSULE, EXTENDED RELEASE / ORAL		2013-01-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A079040-006	MORPHINE SULFATE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	RS	2013-01-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A079040-001	MORPHINE SULFATE	30MG	CAPSULE, EXTENDED RELEASE / ORAL		2013-01-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079040-002	MORPHINE SULFATE	45MG	CAPSULE, EXTENDED RELEASE / ORAL		2013-01-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079040-003	MORPHINE SULFATE	60MG	CAPSULE, EXTENDED RELEASE / ORAL		2013-01-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079040-004	MORPHINE SULFATE	75MG	CAPSULE, EXTENDED RELEASE / ORAL		2013-01-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079040-005	MORPHINE SULFATE	90MG	CAPSULE, EXTENDED RELEASE / ORAL		2013-01-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079040-006	MORPHINE SULFATE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	RS	2013-01-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079040-001	MORPHINE SULFATE	30MG	CAPSULE, EXTENDED RELEASE / ORAL		2013-01-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079040-002	MORPHINE SULFATE	45MG	CAPSULE, EXTENDED RELEASE / ORAL		2013-01-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079040-003	MORPHINE SULFATE	60MG	CAPSULE, EXTENDED RELEASE / ORAL		2013-01-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079040-004	MORPHINE SULFATE	75MG	CAPSULE, EXTENDED RELEASE / ORAL		2013-01-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079040-005	MORPHINE SULFATE	90MG	CAPSULE, EXTENDED RELEASE / ORAL		2013-01-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079040-006	MORPHINE SULFATE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	RS	2013-01-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A079040-001	MORPHINE SULFATE	30MG	CAPSULE, EXTENDED RELEASE / ORAL		2013-01-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079040-002	MORPHINE SULFATE	45MG	CAPSULE, EXTENDED RELEASE / ORAL		2013-01-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079040-003	MORPHINE SULFATE	60MG	CAPSULE, EXTENDED RELEASE / ORAL		2013-01-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079040-004	MORPHINE SULFATE	75MG	CAPSULE, EXTENDED RELEASE / ORAL		2013-01-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079040-005	MORPHINE SULFATE	90MG	CAPSULE, EXTENDED RELEASE / ORAL		2013-01-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079040-006	MORPHINE SULFATE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	RS	2013-01-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079040-001	MORPHINE SULFATE	30MG	CAPSULE, EXTENDED RELEASE / ORAL		2013-01-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079040-002	MORPHINE SULFATE	45MG	CAPSULE, EXTENDED RELEASE / ORAL		2013-01-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079040-003	MORPHINE SULFATE	60MG	CAPSULE, EXTENDED RELEASE / ORAL		2013-01-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079040-004	MORPHINE SULFATE	75MG	CAPSULE, EXTENDED RELEASE / ORAL		2013-01-16	`fd3edfee7708…`

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 4 of 4 · 70 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Morphine sulfate	MORPHINE SULFATE	Bryant Ranch Prepack	73a39ce5-b2ab-47b9-8860-796f1d5bc8d8	2024-04-03	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Morphine sulfate generic name: MORPHINE SULFATE
Morphine sulfate	MORPHINE SULFATE	Bryant Ranch Prepack	ad08cd86-3825-4e77-bbe8-f6333a9ca9d7	2024-04-03	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Morphine sulfate generic name: MORPHINE SULFATE
Morphine Sulfate	MORPHINE SULFATE	Lupin Pharmaceuticals,Inc.	d360a33f-6323-4b10-9e81-07e2813c2dbd	2024-02-16	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Morphine Sulfate generic name: MORPHINE SULFATE
Morphine Sulfate	MORPHINE SULFATE	Bryant Ranch Prepack	efccad6e-213b-4335-9a4f-3b81322f77c4	2024-01-11	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Morphine Sulfate generic name: MORPHINE SULFATE
Morphine Sulfate	MORPHINE SULFATE	Bryant Ranch Prepack	f4f9a7cd-fa6c-41cd-8c4b-04626cfa410a	2024-01-11	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Morphine Sulfate generic name: MORPHINE SULFATE
Morphine Sulfate	MORPHINE SULFATE	Bryant Ranch Prepack	72e2071a-43d6-4480-bb84-4984a976618b	2024-01-11	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Morphine Sulfate generic name: MORPHINE SULFATE
Morphine Sulfate	MORPHINE SULFATE	Bryant Ranch Prepack	996ac31e-589f-4d5a-84bc-8350e7ea864f	2024-01-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Morphine Sulfate generic name: MORPHINE SULFATE
Morphine Sulfate	MORPHINE SULFATE	Padagis US LLC	649d731b-962a-45df-b043-7e0781e8a530	2023-07-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Morphine Sulfate generic name: MORPHINE SULFATE
Morphine Sulfate	MORPHINE SULFATE	Bryant Ranch Prepack	b7b86b6d-9a39-494c-bf65-f62e4cdc5807	2023-03-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Morphine Sulfate generic name: MORPHINE SULFATE
Morphine Sulfate	MORPHINE SULFATE	Winder Laboratories LLC	e9a7319a-bf1f-48db-a71e-6d4e6ead9555	2022-02-28	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 · 36 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0228-3090	Morphine sulfate	Morphine sulfate	Actavis Pharma, Inc.	ANDA	Current
0228-3090	Morphine sulfate	Morphine sulfate	Actavis Pharma, Inc.	ANDA	Current
0228-3090	Morphine sulfate	Morphine sulfate	Actavis Pharma, Inc.	ANDA	Current
0228-3090	Morphine sulfate	Morphine sulfate	Actavis Pharma, Inc.	ANDA	Current
0228-3090	Morphine sulfate	Morphine sulfate	Actavis Pharma, Inc.	ANDA	Current
0228-3090	Morphine sulfate	Morphine sulfate	Actavis Pharma, Inc.	ANDA	Current
0228-3091	Morphine sulfate	Morphine sulfate	Actavis Pharma, Inc.	ANDA	Current
0228-3091	Morphine sulfate	Morphine sulfate	Actavis Pharma, Inc.	ANDA	Current
0228-3091	Morphine sulfate	Morphine sulfate	Actavis Pharma, Inc.	ANDA	Current
0228-3091	Morphine sulfate	Morphine sulfate	Actavis Pharma, Inc.	ANDA	Current
0228-3091	Morphine sulfate	Morphine sulfate	Actavis Pharma, Inc.	ANDA	Current
0228-3091	Morphine sulfate	Morphine sulfate	Actavis Pharma, Inc.	ANDA	Current
0228-3092	Morphine sulfate	Morphine sulfate	Actavis Pharma, Inc.	ANDA	Current
0228-3092	Morphine sulfate	Morphine sulfate	Actavis Pharma, Inc.	ANDA	Current
0228-3092	Morphine sulfate	Morphine sulfate	Actavis Pharma, Inc.	ANDA	Current
0228-3092	Morphine sulfate	Morphine sulfate	Actavis Pharma, Inc.	ANDA	Current
0228-3092	Morphine sulfate	Morphine sulfate	Actavis Pharma, Inc.	ANDA	Current
0228-3092	Morphine sulfate	Morphine sulfate	Actavis Pharma, Inc.	ANDA	Current
0228-3093	Morphine sulfate	Morphine sulfate	Actavis Pharma, Inc.	ANDA	Current
0228-3093	Morphine sulfate	Morphine sulfate	Actavis Pharma, Inc.	ANDA	Current
0228-3093	Morphine sulfate	Morphine sulfate	Actavis Pharma, Inc.	ANDA	Current
0228-3093	Morphine sulfate	Morphine sulfate	Actavis Pharma, Inc.	ANDA	Current
0228-3093	Morphine sulfate	Morphine sulfate	Actavis Pharma, Inc.	ANDA	Current
0228-3093	Morphine sulfate	Morphine sulfate	Actavis Pharma, Inc.	ANDA	Current
0228-3116	Morphine sulfate	Morphine sulfate	Actavis Pharma, Inc.	ANDA	Current
0228-3116	Morphine sulfate	Morphine sulfate	Actavis Pharma, Inc.	ANDA	Current
0228-3116	Morphine sulfate	Morphine sulfate	Actavis Pharma, Inc.	ANDA	Current
0228-3116	Morphine sulfate	Morphine sulfate	Actavis Pharma, Inc.	ANDA	Current
0228-3116	Morphine sulfate	Morphine sulfate	Actavis Pharma, Inc.	ANDA	Current
0228-3116	Morphine sulfate	Morphine sulfate	Actavis Pharma, Inc.	ANDA	Current
0228-3117	Morphine sulfate	Morphine sulfate	Actavis Pharma, Inc.	ANDA	Current
0228-3117	Morphine sulfate	Morphine sulfate	Actavis Pharma, Inc.	ANDA	Current
0228-3117	Morphine sulfate	Morphine sulfate	Actavis Pharma, Inc.	ANDA	Current
0228-3117	Morphine sulfate	Morphine sulfate	Actavis Pharma, Inc.	ANDA	Current
0228-3117	Morphine sulfate	Morphine sulfate	Actavis Pharma, Inc.	ANDA	Current
0228-3117	Morphine sulfate	Morphine sulfate	Actavis Pharma, Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
24064	ORIG	2015-06-30
43156	ORIG	2013-02-27