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 1.

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 · 246 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	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…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021260-005	AVINZA	45MG	CAPSULE, EXTENDED RELEASE / ORAL	2008-12-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021260-006	AVINZA	75MG	CAPSULE, EXTENDED RELEASE / ORAL	2008-12-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021260-001	AVINZA	30MG	CAPSULE, EXTENDED RELEASE / ORAL	2002-03-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021260-002	AVINZA	60MG	CAPSULE, EXTENDED RELEASE / ORAL	2002-03-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021260-003	AVINZA	90MG	CAPSULE, EXTENDED RELEASE / ORAL	2002-03-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021260-004	AVINZA	120MG	CAPSULE, EXTENDED RELEASE / ORAL	2002-03-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021260-005	AVINZA	45MG	CAPSULE, EXTENDED RELEASE / ORAL	2008-12-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021260-006	AVINZA	75MG	CAPSULE, EXTENDED RELEASE / ORAL	2008-12-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021260-001	AVINZA	30MG	CAPSULE, EXTENDED RELEASE / ORAL	2002-03-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021260-002	AVINZA	60MG	CAPSULE, EXTENDED RELEASE / ORAL	2002-03-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021260-003	AVINZA	90MG	CAPSULE, EXTENDED RELEASE / ORAL	2002-03-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021260-004	AVINZA	120MG	CAPSULE, EXTENDED RELEASE / ORAL	2002-03-20	`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 4 · 73 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Morphine Sulfate	MORPHINE SULFATE	Redpharm Drug	58476a6b-b54b-5491-e063-6394a90a38c6	2026-08-05	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MORPHINE SULFATE
Morphine Sulfate	MORPHINE SULFATE	SpecGx LLC	8b69f67f-30b3-4982-953e-5a4b87ec6ac6	2026-07-30	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MORPHINE SULFATE
MORPHINE SULFATE	MORPHINE SULFATE	St. Mary's Medical Park Pharmacy	57ee014e-744e-65e1-e063-6394a90a8c93	2026-07-30	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MORPHINE SULFATE
Morphine Sulfate	MORPHINE SULFATE	SpecGx LLC	242c2512-1d49-486b-a9c3-6905f667799e	2026-07-28	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MORPHINE SULFATE
Morphine sulfate	MORPHINE SULFATE	Bryant Ranch Prepack	595243fe-a4b1-479a-99d6-a084a4181891	2026-07-13	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MORPHINE SULFATE
Morphine Sulfate	MORPHINE SULFATE	Hikma Pharmaceuticals USA Inc.	6023606c-150c-40c5-9175-598efe2a56c3	2026-07-02	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MORPHINE SULFATE
Morphine Sulfate	MORPHINE SULFATE	Precision Dose, Inc.	6654b91e-3b3f-4062-ac65-a2a70f942da4	2026-06-19	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MORPHINE SULFATE
Morphine Sulfate	MORPHINE SULFATE	Precision Dose, Inc.	bb6b3439-9f0c-45f5-bf6f-c7a971af0a8f	2026-06-19	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MORPHINE SULFATE
Morphine Sulfate	MORPHINE SULFATE	Precision Dose, Inc.	76966c05-df75-4072-ae99-97e42f91ab75	2026-06-19	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MORPHINE SULFATE
Morphine Sulfate	MORPHINE SULFATE	Precision Dose, Inc.	67f0ee8d-696e-4c08-9007-3df0e3988bad	2026-06-09	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MORPHINE SULFATE
Morphine Sulfate Extended Release	MORPHINE SULFATE	Major Pharmaceuticals	dbb37dfd-0196-45f7-b9ca-393f56cf1d28	2026-05-26	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MORPHINE SULFATE
Morphine Sulfate	MORPHINE SULFATE	Bryant Ranch Prepack	367d508b-3226-42a9-8dc6-f67cdc9979f3	2026-05-26	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MORPHINE SULFATE
Morphine Sulfate	MORPHINE SULFATE	Precision Dose Inc.	8d800d8e-8fe2-453b-a8ac-dcf7c47e55fc	2026-05-26	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MORPHINE SULFATE
MS Contin	MORPHINE SULFATE	Rhodes Pharmaceuticals LLC	c354b3bf-86c0-4bb8-8b1f-be2164942698	2026-05-18	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MORPHINE SULFATE
Morphine Sulfate Extended Release	MORPHINE SULFATE	Rhodes Pharmaceuticals LLC	19c7d9cc-6ce2-4c5c-8c3f-c24fd3342804	2026-05-04	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MORPHINE SULFATE
Morphine Sulfate	MORPHINE SULFATE	Hospira, Inc.	1d181906-f3ec-4222-1883-e61577a3122e	2026-04-21	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MORPHINE SULFATE
Morphine Sulfate Extended Release	MORPHINE SULFATE	Bryant Ranch Prepack	2dd52157-3121-41ed-abc2-99b269531e56	2026-04-14	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MORPHINE SULFATE
MORPHINE SULFATE	MORPHINE SULFATE	Bryant Ranch Prepack	d1b0b4ac-69d9-44bf-b7a3-229bd89b9fd6	2026-04-13	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MORPHINE SULFATE
Morphine Sulfate Extended Release	MORPHINE SULFATE	Bryant Ranch Prepack	c94d9da6-7a12-44ee-a38f-3323ee27842c	2026-04-03	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MORPHINE SULFATE
Morphine Sulfate ER	MORPHINE SULFATE	Bryant Ranch Prepack	872ceecb-1f14-7a43-7451-e4650a01fbd9	2026-04-02	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MORPHINE SULFATE

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