Application 021260

Type: NDA
Sponsor: KING PHARMS LLC

Application Products#

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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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	Approval date
N021260-001	AVINZA	MORPHINE SULFATE	30MG	CAPSULE, EXTENDED RELEASE / ORAL	2002-03-20
N021260-002	AVINZA	MORPHINE SULFATE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	2002-03-20
N021260-003	AVINZA	MORPHINE SULFATE	90MG	CAPSULE, EXTENDED RELEASE / ORAL	2002-03-20
N021260-004	AVINZA	MORPHINE SULFATE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	2002-03-20
N021260-005	AVINZA	MORPHINE SULFATE	45MG	CAPSULE, EXTENDED RELEASE / ORAL	2008-12-18
N021260-006	AVINZA	MORPHINE SULFATE	75MG	CAPSULE, EXTENDED RELEASE / ORAL	2008-12-18

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 · 258 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N021260-001	AVINZA	30MG	CAPSULE, EXTENDED RELEASE / ORAL	2002-03-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021260-002	AVINZA	60MG	CAPSULE, EXTENDED RELEASE / ORAL	2002-03-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021260-003	AVINZA	90MG	CAPSULE, EXTENDED RELEASE / ORAL	2002-03-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021260-004	AVINZA	120MG	CAPSULE, EXTENDED RELEASE / ORAL	2002-03-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021260-005	AVINZA	45MG	CAPSULE, EXTENDED RELEASE / ORAL	2008-12-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021260-006	AVINZA	75MG	CAPSULE, EXTENDED RELEASE / ORAL	2008-12-18	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021260-001	AVINZA	30MG	CAPSULE, EXTENDED RELEASE / ORAL	2002-03-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021260-002	AVINZA	60MG	CAPSULE, EXTENDED RELEASE / ORAL	2002-03-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021260-003	AVINZA	90MG	CAPSULE, EXTENDED RELEASE / ORAL	2002-03-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021260-004	AVINZA	120MG	CAPSULE, EXTENDED RELEASE / ORAL	2002-03-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021260-005	AVINZA	45MG	CAPSULE, EXTENDED RELEASE / ORAL	2008-12-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021260-006	AVINZA	75MG	CAPSULE, EXTENDED RELEASE / ORAL	2008-12-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021260-001	AVINZA	30MG	CAPSULE, EXTENDED RELEASE / ORAL	2002-03-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021260-002	AVINZA	60MG	CAPSULE, EXTENDED RELEASE / ORAL	2002-03-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021260-003	AVINZA	90MG	CAPSULE, EXTENDED RELEASE / ORAL	2002-03-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021260-004	AVINZA	120MG	CAPSULE, EXTENDED RELEASE / ORAL	2002-03-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021260-005	AVINZA	45MG	CAPSULE, EXTENDED RELEASE / ORAL	2008-12-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021260-006	AVINZA	75MG	CAPSULE, EXTENDED RELEASE / ORAL	2008-12-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021260-001	AVINZA	30MG	CAPSULE, EXTENDED RELEASE / ORAL	2002-03-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021260-002	AVINZA	60MG	CAPSULE, EXTENDED RELEASE / ORAL	2002-03-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021260-003	AVINZA	90MG	CAPSULE, EXTENDED RELEASE / ORAL	2002-03-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021260-004	AVINZA	120MG	CAPSULE, EXTENDED RELEASE / ORAL	2002-03-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021260-005	AVINZA	45MG	CAPSULE, EXTENDED RELEASE / ORAL	2008-12-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021260-006	AVINZA	75MG	CAPSULE, EXTENDED RELEASE / ORAL	2008-12-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021260-001	AVINZA	30MG	CAPSULE, EXTENDED RELEASE / ORAL	2002-03-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021260-002	AVINZA	60MG	CAPSULE, EXTENDED RELEASE / ORAL	2002-03-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021260-003	AVINZA	90MG	CAPSULE, EXTENDED RELEASE / ORAL	2002-03-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021260-004	AVINZA	120MG	CAPSULE, EXTENDED RELEASE / ORAL	2002-03-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021260-005	AVINZA	45MG	CAPSULE, EXTENDED RELEASE / ORAL	2008-12-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021260-006	AVINZA	75MG	CAPSULE, EXTENDED RELEASE / ORAL	2008-12-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021260-001	AVINZA	30MG	CAPSULE, EXTENDED RELEASE / ORAL	2002-03-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021260-002	AVINZA	60MG	CAPSULE, EXTENDED RELEASE / ORAL	2002-03-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021260-003	AVINZA	90MG	CAPSULE, EXTENDED RELEASE / ORAL	2002-03-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021260-004	AVINZA	120MG	CAPSULE, EXTENDED RELEASE / ORAL	2002-03-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021260-005	AVINZA	45MG	CAPSULE, EXTENDED RELEASE / ORAL	2008-12-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021260-006	AVINZA	75MG	CAPSULE, EXTENDED RELEASE / ORAL	2008-12-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021260-001	AVINZA	30MG	CAPSULE, EXTENDED RELEASE / ORAL	2002-03-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021260-002	AVINZA	60MG	CAPSULE, EXTENDED RELEASE / ORAL	2002-03-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021260-003	AVINZA	90MG	CAPSULE, EXTENDED RELEASE / ORAL	2002-03-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021260-004	AVINZA	120MG	CAPSULE, EXTENDED RELEASE / ORAL	2002-03-20	`b8a1b40f171c…`

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 3 of 4 · 73 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
INFUMORPH 200	MORPHINE SULFATE	Hikma Pharmaceuticals USA Inc.	db9ac9e3-d761-4a99-9f34-4946ebe8f255	2025-12-31	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MORPHINE SULFATE
Morphine Sulfate	MORPHINE SULFATE	Redpharm Drug	300b6afd-bac8-32ca-e063-6294a90a12a7	2025-12-23	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MORPHINE SULFATE
Morphine Sulfate	MORPHINE SULFATE	Upsher-Smith Laboratories, LLC	5ceb3205-2f8d-4ba3-9f27-dc328bab4fa1	2025-12-23	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MORPHINE SULFATE
Morphine Sulfate	MORPHINE SULFATE	American Health Packaging	d66d0cfb-9bfe-490c-90ee-49481c567e85	2025-12-05	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MORPHINE SULFATE
Morphine Sulfate	MORPHINE SULFATE	Amneal Pharmaceuticals of New York LLC	f7e9a4b3-a2ee-4f0a-becd-6ef90867332b	2025-11-28	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MORPHINE SULFATE
Morphine Sulfate	MORPHINE SULFATE	American Health Packaging	9f1ba2a2-d8ac-4f59-a587-fe413e56dcdb	2025-11-11	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MORPHINE SULFATE
MORPHINE SULFATE	MORPHINE SULFATE	Ascend Laboratories, LLC	07593aa4-f2c4-4d6e-b186-ab2a4ecaa38a	2025-10-10	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MORPHINE SULFATE
Morphine Sulfate	MORPHINE SULFATE	Nortec Development Associates, Inc.	9c1a5b8b-8faa-4ee0-80bd-853c239bb1c4	2025-08-25	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MORPHINE SULFATE
Morphine sulfate	MORPHINE SULFATE	Bryant Ranch Prepack	47ea2424-ce2f-4b3b-b393-da1886e7a383	2025-07-30	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MORPHINE SULFATE
Morphine Sulfate	MORPHINE SULFATE	Civica, Inc.	9362eca1-2bc9-4f72-8895-0b9179bfeb2b	2025-07-15	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MORPHINE SULFATE
Morphine Sulfate	MORPHINE SULFATE	Upsher-Smith Laboratories, LLC	97948a8f-7d1b-4614-b11d-e944cf56590b	2025-07-09	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MORPHINE SULFATE
MORPHINE SULFATE	MORPHINE SULFATE	Bryant Ranch Prepack	905cd842-2c86-4318-a6c4-92f49de145b3	2025-06-16	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MORPHINE SULFATE
Morphine Sulfate Extended Release	MORPHINE SULFATE	American Health Packaging	f915420d-981d-455b-b4cf-67c8e201a136	2024-12-30	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MORPHINE SULFATE
Morphine Sulfate	MORPHINE SULFATE	International Medication Systems, Limited	1034467f-d436-4b87-a902-c7e8885daa8a	2024-12-30	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MORPHINE SULFATE
Morphine Sulfate	MORPHINE SULFATE	Bryant Ranch Prepack	9bb1fef7-4159-4dca-8a8c-37e53ccc6bab	2024-12-06	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MORPHINE SULFATE
Morphine Sulfate	MORPHINE SULFATE	PAI Holdings, LLC dba PAI Pharma	6e32b869-31c7-48c1-98ae-b21bd28151d7	2024-11-19	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MORPHINE SULFATE
Morphine sulfate	MORPHINE SULFATE	Bryant Ranch Prepack	2f15f27b-95ed-4cc8-8937-eae07917a6dd	2024-08-22	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MORPHINE SULFATE
Morphine sulfate	MORPHINE SULFATE	Bryant Ranch Prepack	20af0f0e-45cc-4795-97ef-90b659575b34	2024-08-20	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MORPHINE SULFATE
Morphine sulfate	MORPHINE SULFATE	Bryant Ranch Prepack	3e310662-16e8-4179-883e-efbca736b14d	2024-08-05	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MORPHINE SULFATE
Morphine sulfate	MORPHINE SULFATE	Bryant Ranch Prepack	7f65fa22-c3fc-4413-8a07-2c6be621b7bf	2024-07-10	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MORPHINE SULFATE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

Document, Submission type, Date table
Document	Submission type	Date
4821	SUPPL	2015-07-06
27252	SUPPL	2014-08-20
4820	SUPPL	2014-04-17
36499	SUPPL	2014-04-16
27251	SUPPL	2013-05-08
36498	SUPPL	2013-05-06
4819	SUPPL	2013-04-16
36497	SUPPL	2012-07-12
14777	SUPPL	2012-07-12
43731	ORIG	2012-07-11
27250	SUPPL	2012-07-11
27249	SUPPL	2012-07-11
23989	ORIG	2012-07-11
4818	SUPPL	2008-12-23
4817	SUPPL	2005-10-25
36496	SUPPL	2005-10-24
42059	ORIG	2004-01-15
14776	ORIG	2002-03-20
4816	ORIG	2002-03-20