Application 021671

Type: NDA
Sponsor: PACIRA PHARMS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DEPODUR	MORPHINE SULFATE	INJECTABLE, LIPOSOMAL;EPIDURAL	10MG/ML (10MG/ML)	No	No
002	DEPODUR	MORPHINE SULFATE	INJECTABLE, LIPOSOMAL;EPIDURAL	15MG/1.5ML (10MG/ML)	No	No
003	DEPODUR	MORPHINE SULFATE	INJECTABLE, LIPOSOMAL;EPIDURAL	20MG/2ML (10MG/ML)	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
N021671-001	DEPODUR	MORPHINE SULFATE	10MG/ML (10MG/ML)	INJECTABLE, LIPOSOMAL / EPIDURAL	2004-05-18
N021671-002	DEPODUR	MORPHINE SULFATE	15MG/1.5ML (10MG/ML)	INJECTABLE, LIPOSOMAL / EPIDURAL	2004-05-18
N021671-003	DEPODUR	MORPHINE SULFATE	20MG/2ML (10MG/ML)	INJECTABLE, LIPOSOMAL / EPIDURAL	2004-05-18

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 4 · 129 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	N021671-001	DEPODUR	10MG/ML (10MG/ML)	INJECTABLE, LIPOSOMAL / EPIDURAL	2004-05-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021671-002	DEPODUR	15MG/1.5ML (10MG/ML)	INJECTABLE, LIPOSOMAL / EPIDURAL	2004-05-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021671-003	DEPODUR	20MG/2ML (10MG/ML)	INJECTABLE, LIPOSOMAL / EPIDURAL	2004-05-18	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021671-001	DEPODUR	10MG/ML (10MG/ML)	INJECTABLE, LIPOSOMAL / EPIDURAL	2004-05-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021671-002	DEPODUR	15MG/1.5ML (10MG/ML)	INJECTABLE, LIPOSOMAL / EPIDURAL	2004-05-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021671-003	DEPODUR	20MG/2ML (10MG/ML)	INJECTABLE, LIPOSOMAL / EPIDURAL	2004-05-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021671-001	DEPODUR	10MG/ML (10MG/ML)	INJECTABLE, LIPOSOMAL / EPIDURAL	2004-05-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021671-002	DEPODUR	15MG/1.5ML (10MG/ML)	INJECTABLE, LIPOSOMAL / EPIDURAL	2004-05-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021671-003	DEPODUR	20MG/2ML (10MG/ML)	INJECTABLE, LIPOSOMAL / EPIDURAL	2004-05-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021671-001	DEPODUR	10MG/ML (10MG/ML)	INJECTABLE, LIPOSOMAL / EPIDURAL	2004-05-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021671-002	DEPODUR	15MG/1.5ML (10MG/ML)	INJECTABLE, LIPOSOMAL / EPIDURAL	2004-05-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021671-003	DEPODUR	20MG/2ML (10MG/ML)	INJECTABLE, LIPOSOMAL / EPIDURAL	2004-05-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021671-001	DEPODUR	10MG/ML (10MG/ML)	INJECTABLE, LIPOSOMAL / EPIDURAL	2004-05-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021671-002	DEPODUR	15MG/1.5ML (10MG/ML)	INJECTABLE, LIPOSOMAL / EPIDURAL	2004-05-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021671-003	DEPODUR	20MG/2ML (10MG/ML)	INJECTABLE, LIPOSOMAL / EPIDURAL	2004-05-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021671-001	DEPODUR	10MG/ML (10MG/ML)	INJECTABLE, LIPOSOMAL / EPIDURAL	2004-05-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021671-002	DEPODUR	15MG/1.5ML (10MG/ML)	INJECTABLE, LIPOSOMAL / EPIDURAL	2004-05-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021671-003	DEPODUR	20MG/2ML (10MG/ML)	INJECTABLE, LIPOSOMAL / EPIDURAL	2004-05-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021671-001	DEPODUR	10MG/ML (10MG/ML)	INJECTABLE, LIPOSOMAL / EPIDURAL	2004-05-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021671-002	DEPODUR	15MG/1.5ML (10MG/ML)	INJECTABLE, LIPOSOMAL / EPIDURAL	2004-05-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021671-003	DEPODUR	20MG/2ML (10MG/ML)	INJECTABLE, LIPOSOMAL / EPIDURAL	2004-05-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021671-001	DEPODUR	10MG/ML (10MG/ML)	INJECTABLE, LIPOSOMAL / EPIDURAL	2004-05-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021671-002	DEPODUR	15MG/1.5ML (10MG/ML)	INJECTABLE, LIPOSOMAL / EPIDURAL	2004-05-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021671-003	DEPODUR	20MG/2ML (10MG/ML)	INJECTABLE, LIPOSOMAL / EPIDURAL	2004-05-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021671-001	DEPODUR	10MG/ML (10MG/ML)	INJECTABLE, LIPOSOMAL / EPIDURAL	2004-05-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021671-002	DEPODUR	15MG/1.5ML (10MG/ML)	INJECTABLE, LIPOSOMAL / EPIDURAL	2004-05-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021671-003	DEPODUR	20MG/2ML (10MG/ML)	INJECTABLE, LIPOSOMAL / EPIDURAL	2004-05-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021671-001	DEPODUR	10MG/ML (10MG/ML)	INJECTABLE, LIPOSOMAL / EPIDURAL	2004-05-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021671-002	DEPODUR	15MG/1.5ML (10MG/ML)	INJECTABLE, LIPOSOMAL / EPIDURAL	2004-05-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021671-003	DEPODUR	20MG/2ML (10MG/ML)	INJECTABLE, LIPOSOMAL / EPIDURAL	2004-05-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021671-001	DEPODUR	10MG/ML (10MG/ML)	INJECTABLE, LIPOSOMAL / EPIDURAL	2004-05-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021671-002	DEPODUR	15MG/1.5ML (10MG/ML)	INJECTABLE, LIPOSOMAL / EPIDURAL	2004-05-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021671-003	DEPODUR	20MG/2ML (10MG/ML)	INJECTABLE, LIPOSOMAL / EPIDURAL	2004-05-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021671-001	DEPODUR	10MG/ML (10MG/ML)	INJECTABLE, LIPOSOMAL / EPIDURAL	2004-05-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021671-002	DEPODUR	15MG/1.5ML (10MG/ML)	INJECTABLE, LIPOSOMAL / EPIDURAL	2004-05-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021671-003	DEPODUR	20MG/2ML (10MG/ML)	INJECTABLE, LIPOSOMAL / EPIDURAL	2004-05-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021671-001	DEPODUR	10MG/ML (10MG/ML)	INJECTABLE, LIPOSOMAL / EPIDURAL	2004-05-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021671-002	DEPODUR	15MG/1.5ML (10MG/ML)	INJECTABLE, LIPOSOMAL / EPIDURAL	2004-05-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021671-003	DEPODUR	20MG/2ML (10MG/ML)	INJECTABLE, LIPOSOMAL / EPIDURAL	2004-05-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021671-001	DEPODUR	10MG/ML (10MG/ML)	INJECTABLE, LIPOSOMAL / EPIDURAL	2004-05-18	`301d65b070ca…`

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 · 73 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	fd98b881-5466-457b-b5af-f102aec61546	2024-06-05	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MORPHINE SULFATE
Morphine sulfate	MORPHINE SULFATE	Bryant Ranch Prepack	9a1ca529-8268-4be3-b03f-b2f2238cc9dc	2024-04-04	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MORPHINE SULFATE
Morphine sulfate	MORPHINE SULFATE	Bryant Ranch Prepack	fb9f929b-8c5a-442b-9695-9d3d45272a5e	2024-04-04	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MORPHINE SULFATE
Morphine sulfate	MORPHINE SULFATE	Bryant Ranch Prepack	73a39ce5-b2ab-47b9-8860-796f1d5bc8d8	2024-04-03	Boxed warning, Warnings, Adverse reactions	Name fallback 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 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 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 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 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 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 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 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 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 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
5957	SUPPL	2009-11-10
37433	SUPPL	2009-10-01
5956	SUPPL	2008-01-09
37432	SUPPL	2007-12-27
15954	SUPPL	2007-02-23
5955	SUPPL	2007-02-23
28344	SUPPL	2007-01-25
15953	SUPPL	2007-01-18
5954	SUPPL	2006-05-25
37431	SUPPL	2006-05-24
42264	ORIG	2006-01-31
28343	SUPPL	2004-08-12
37430	ORIG	2004-05-27
28342	ORIG	2004-05-26