Application 020616

Type: NDA
Sponsor: ALLERGAN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	KADIAN	MORPHINE SULFATE	CAPSULE, EXTENDED RELEASE;ORAL	20MG	Yes	No
002	KADIAN	MORPHINE SULFATE	CAPSULE, EXTENDED RELEASE;ORAL	50MG	Yes	No
003	KADIAN	MORPHINE SULFATE	CAPSULE, EXTENDED RELEASE;ORAL	100MG	Yes	Yes
004	KADIAN	MORPHINE SULFATE	CAPSULE, EXTENDED RELEASE;ORAL	30MG	Yes	No
005	KADIAN	MORPHINE SULFATE	CAPSULE, EXTENDED RELEASE;ORAL	60MG	Yes	No
006	KADIAN	MORPHINE SULFATE	CAPSULE, EXTENDED RELEASE;ORAL	80MG	Yes	No
007	KADIAN	MORPHINE SULFATE	CAPSULE, EXTENDED RELEASE;ORAL	200MG	Yes	Yes
008	KADIAN	MORPHINE SULFATE	CAPSULE, EXTENDED RELEASE;ORAL	10MG	Yes	Yes
009	KADIAN	MORPHINE SULFATE	CAPSULE, EXTENDED RELEASE;ORAL	40MG	Yes	No
010	KADIAN	MORPHINE SULFATE	CAPSULE, EXTENDED RELEASE;ORAL	70MG	Yes	No
011	KADIAN	MORPHINE SULFATE	CAPSULE, EXTENDED RELEASE;ORAL	130MG	Yes	No
012	KADIAN	MORPHINE SULFATE	CAPSULE, EXTENDED RELEASE;ORAL	150MG	Yes	No

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

Orange Book products#

Current product rows page 1 of 1 · 12 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N020616-001	KADIAN	MORPHINE SULFATE	20MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	1996-07-03
N020616-002	KADIAN	MORPHINE SULFATE	50MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	1996-07-03
N020616-003	KADIAN	MORPHINE SULFATE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	1996-07-03
N020616-004	KADIAN	MORPHINE SULFATE	30MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2001-03-09
N020616-005	KADIAN	MORPHINE SULFATE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2001-03-09
N020616-006	KADIAN	MORPHINE SULFATE	80MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2006-10-27
N020616-007	KADIAN	MORPHINE SULFATE	200MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2007-02-27
N020616-008	KADIAN	MORPHINE SULFATE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2007-04-20
N020616-009	KADIAN	MORPHINE SULFATE	40MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2012-07-09
N020616-010	KADIAN	MORPHINE SULFATE	70MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2012-07-09
N020616-011	KADIAN	MORPHINE SULFATE	130MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2012-07-09
N020616-012	KADIAN	MORPHINE SULFATE	150MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2012-07-09

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 13 · 516 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N020616-001	KADIAN	20MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	1996-07-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020616-002	KADIAN	50MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	1996-07-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020616-003	KADIAN	100MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	1996-07-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020616-004	KADIAN	30MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2001-03-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020616-005	KADIAN	60MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2001-03-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020616-006	KADIAN	80MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2006-10-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020616-007	KADIAN	200MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2007-02-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020616-008	KADIAN	10MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2007-04-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020616-009	KADIAN	40MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2012-07-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020616-010	KADIAN	70MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2012-07-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020616-011	KADIAN	130MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2012-07-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020616-012	KADIAN	150MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2012-07-09	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N020616-001	KADIAN	20MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	1996-07-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020616-002	KADIAN	50MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	1996-07-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020616-003	KADIAN	100MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	1996-07-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020616-004	KADIAN	30MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2001-03-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020616-005	KADIAN	60MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2001-03-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020616-006	KADIAN	80MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2006-10-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020616-007	KADIAN	200MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2007-02-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020616-008	KADIAN	10MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2007-04-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020616-009	KADIAN	40MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2012-07-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020616-010	KADIAN	70MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2012-07-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020616-011	KADIAN	130MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2012-07-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020616-012	KADIAN	150MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2012-07-09	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020616-001	KADIAN	20MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	1996-07-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020616-002	KADIAN	50MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	1996-07-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020616-003	KADIAN	100MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	1996-07-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020616-004	KADIAN	30MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2001-03-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020616-005	KADIAN	60MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2001-03-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020616-006	KADIAN	80MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2006-10-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020616-007	KADIAN	200MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2007-02-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020616-008	KADIAN	10MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2007-04-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020616-009	KADIAN	40MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2012-07-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020616-010	KADIAN	70MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2012-07-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020616-011	KADIAN	130MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2012-07-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020616-012	KADIAN	150MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2012-07-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020616-001	KADIAN	20MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	1996-07-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020616-002	KADIAN	50MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	1996-07-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020616-003	KADIAN	100MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	1996-07-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020616-004	KADIAN	30MG	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2001-03-09	`31067a03dcf5…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 68 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N020616-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020616-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020616-003	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020616-004	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020616-005	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020616-006	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020616-008	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020616-009	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020616-010	AB	1	`74a2ff9319b5…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020616-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020616-002	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020616-003	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020616-004	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020616-005	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020616-006	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020616-008	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020616-009	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020616-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N020616-002	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N020616-003	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N020616-004	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N020616-005	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N020616-006	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N020616-008	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N020616-009	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020616-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N020616-002	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N020616-003	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N020616-004	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N020616-005	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N020616-006	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N020616-008	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N020616-009	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020616-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N020616-002	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N020616-003	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N020616-004	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N020616-005	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N020616-006	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N020616-008	AB	1	`c0c555d07b60…`

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.

NDC Listings For This Application#

NDC listings for this application page 1 of 2 · 118 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0023-6011	Kadian	morphine sulfate	Allergan, Inc.	NDA	Current
0023-6011	Kadian	morphine sulfate	Allergan, Inc.	NDA	Current
0023-6011	Kadian	morphine sulfate	Allergan, Inc.	NDA	Current
0023-6011	Kadian	morphine sulfate	Allergan, Inc.	NDA	Current
0023-6011	Kadian	morphine sulfate	Allergan, Inc.	NDA	Current
0023-6011	Kadian	morphine sulfate	Allergan, Inc.	NDA	Current
0023-6012	Kadian	morphine sulfate	Allergan, Inc.	NDA	Current
0023-6012	Kadian	morphine sulfate	Allergan, Inc.	NDA	Current
0023-6012	Kadian	morphine sulfate	Allergan, Inc.	NDA	Current
0023-6012	Kadian	morphine sulfate	Allergan, Inc.	NDA	Current
0023-6012	Kadian	morphine sulfate	Allergan, Inc.	NDA	Current
0023-6012	Kadian	morphine sulfate	Allergan, Inc.	NDA	Current
0023-6013	Kadian	morphine sulfate	Allergan, Inc.	NDA	Current
0023-6013	Kadian	morphine sulfate	Allergan, Inc.	NDA	Current
0023-6013	Kadian	morphine sulfate	Allergan, Inc.	NDA	Current
0023-6013	Kadian	morphine sulfate	Allergan, Inc.	NDA	Current
0023-6013	Kadian	morphine sulfate	Allergan, Inc.	NDA	Current
0023-6013	Kadian	morphine sulfate	Allergan, Inc.	NDA	Current
0023-6014	Kadian	morphine sulfate	Allergan, Inc.	NDA	Current
0023-6014	Kadian	morphine sulfate	Allergan, Inc.	NDA	Current
0023-6014	Kadian	morphine sulfate	Allergan, Inc.	NDA	Current
0023-6014	Kadian	morphine sulfate	Allergan, Inc.	NDA	Current
0023-6014	Kadian	morphine sulfate	Allergan, Inc.	NDA	Current
0023-6015	Kadian	morphine sulfate	Allergan, Inc.	NDA	Current
0023-6015	Kadian	morphine sulfate	Allergan, Inc.	NDA	Current
0023-6015	Kadian	morphine sulfate	Allergan, Inc.	NDA	Current
0023-6015	Kadian	morphine sulfate	Allergan, Inc.	NDA	Current
0023-6015	Kadian	morphine sulfate	Allergan, Inc.	NDA	Current
0023-6015	Kadian	morphine sulfate	Allergan, Inc.	NDA	Current
0023-6016	Kadian	morphine sulfate	Allergan, Inc.	NDA	Current
0023-6016	Kadian	morphine sulfate	Allergan, Inc.	NDA	Current
0023-6016	Kadian	morphine sulfate	Allergan, Inc.	NDA	Current
0023-6016	Kadian	morphine sulfate	Allergan, Inc.	NDA	Current
0023-6016	Kadian	morphine sulfate	Allergan, Inc.	NDA	Current
0023-6016	Kadian	morphine sulfate	Allergan, Inc.	NDA	Current
0023-6017	Kadian	morphine sulfate	Allergan, Inc.	NDA	Current
0023-6017	Kadian	morphine sulfate	Allergan, Inc.	NDA	Current
0023-6017	Kadian	morphine sulfate	Allergan, Inc.	NDA	Current
0023-6017	Kadian	morphine sulfate	Allergan, Inc.	NDA	Current
0023-6017	Kadian	morphine sulfate	Allergan, Inc.	NDA	Current
0023-6017	Kadian	morphine sulfate	Allergan, Inc.	NDA	Current
0023-6018	Kadian	morphine sulfate	Allergan, Inc.	NDA	Current
0023-6018	Kadian	morphine sulfate	Allergan, Inc.	NDA	Current
0023-6018	Kadian	morphine sulfate	Allergan, Inc.	NDA	Current
0023-6018	Kadian	morphine sulfate	Allergan, Inc.	NDA	Current
0023-6018	Kadian	morphine sulfate	Allergan, Inc.	NDA	Current
0023-6018	Kadian	morphine sulfate	Allergan, Inc.	NDA	Current
0023-6019	Kadian	morphine sulfate	Allergan, Inc.	NDA	Current
0023-6019	Kadian	morphine sulfate	Allergan, Inc.	NDA	Current
0023-6019	Kadian	morphine sulfate	Allergan, Inc.	NDA	Current
0023-6019	Kadian	morphine sulfate	Allergan, Inc.	NDA	Current
0023-6019	Kadian	morphine sulfate	Allergan, Inc.	NDA	Current
0023-6019	Kadian	morphine sulfate	Allergan, Inc.	NDA	Current
0228-3501	Morphine sulfate	Morphine sulfate	Actavis Pharma, Inc.	NDA AUTHORIZED GENERIC	Current
0228-3501	Morphine sulfate	Morphine sulfate	Actavis Pharma, Inc.	NDA AUTHORIZED GENERIC	Current
0228-3501	Morphine sulfate	Morphine sulfate	Actavis Pharma, Inc.	NDA AUTHORIZED GENERIC	Current
0228-3501	Morphine sulfate	Morphine sulfate	Actavis Pharma, Inc.	NDA AUTHORIZED GENERIC	Current
0228-3501	Morphine sulfate	Morphine sulfate	Actavis Pharma, Inc.	NDA AUTHORIZED GENERIC	Current
0228-3501	Morphine sulfate	Morphine sulfate	Actavis Pharma, Inc.	NDA AUTHORIZED GENERIC	Current
0228-3501	Morphine sulfate	Morphine sulfate	Actavis Pharma, Inc.	NDA AUTHORIZED GENERIC	Current
0228-3502	Morphine sulfate	Morphine sulfate	Actavis Pharma, Inc.	NDA AUTHORIZED GENERIC	Current
0228-3502	Morphine sulfate	Morphine sulfate	Actavis Pharma, Inc.	NDA AUTHORIZED GENERIC	Current
0228-3502	Morphine sulfate	Morphine sulfate	Actavis Pharma, Inc.	NDA AUTHORIZED GENERIC	Current
0228-3502	Morphine sulfate	Morphine sulfate	Actavis Pharma, Inc.	NDA AUTHORIZED GENERIC	Current
0228-3502	Morphine sulfate	Morphine sulfate	Actavis Pharma, Inc.	NDA AUTHORIZED GENERIC	Current
0228-3502	Morphine sulfate	Morphine sulfate	Actavis Pharma, Inc.	NDA AUTHORIZED GENERIC	Current
0228-3502	Morphine sulfate	Morphine sulfate	Actavis Pharma, Inc.	NDA AUTHORIZED GENERIC	Current
0228-3503	Morphine sulfate	Morphine sulfate	Actavis Pharma, Inc.	NDA AUTHORIZED GENERIC	Current
0228-3503	Morphine sulfate	Morphine sulfate	Actavis Pharma, Inc.	NDA AUTHORIZED GENERIC	Current
0228-3503	Morphine sulfate	Morphine sulfate	Actavis Pharma, Inc.	NDA AUTHORIZED GENERIC	Current
0228-3503	Morphine sulfate	Morphine sulfate	Actavis Pharma, Inc.	NDA AUTHORIZED GENERIC	Current
0228-3503	Morphine sulfate	Morphine sulfate	Actavis Pharma, Inc.	NDA AUTHORIZED GENERIC	Current
0228-3503	Morphine sulfate	Morphine sulfate	Actavis Pharma, Inc.	NDA AUTHORIZED GENERIC	Current
0228-3503	Morphine sulfate	Morphine sulfate	Actavis Pharma, Inc.	NDA AUTHORIZED GENERIC	Current
0228-3504	Morphine sulfate	Morphine sulfate	Actavis Pharma, Inc.	NDA AUTHORIZED GENERIC	Current
0228-3504	Morphine sulfate	Morphine sulfate	Actavis Pharma, Inc.	NDA AUTHORIZED GENERIC	Current
0228-3504	Morphine sulfate	Morphine sulfate	Actavis Pharma, Inc.	NDA AUTHORIZED GENERIC	Current
0228-3504	Morphine sulfate	Morphine sulfate	Actavis Pharma, Inc.	NDA AUTHORIZED GENERIC	Current
0228-3504	Morphine sulfate	Morphine sulfate	Actavis Pharma, Inc.	NDA AUTHORIZED GENERIC	Current
0228-3504	Morphine sulfate	Morphine sulfate	Actavis Pharma, Inc.	NDA AUTHORIZED GENERIC	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
66587	SUPPL	2021-03-08
66586	SUPPL	2021-03-08
66505	SUPPL	2021-03-05
60343	SUPPL	2019-10-08
60329	SUPPL	2019-10-08
60328	SUPPL	2019-10-08
55901	SUPPL	2018-10-12
55900	SUPPL	2018-10-12
55661	SUPPL	2018-09-28
55660	SUPPL	2018-09-28
48568	SUPPL	2017-05-30
46383	SUPPL	2016-12-21
46253	SUPPL	2016-12-20
45462	SUPPL	2016-10-04
2888	SUPPL	2016-04-22
2887	SUPPL	2015-07-02
2886	SUPPL	2014-08-20
2885	SUPPL	2014-04-17
34964	SUPPL	2014-04-16
25330	SUPPL	2013-04-17
2884	SUPPL	2013-03-29
34963	SUPPL	2012-07-13
34962	SUPPL	2012-07-12
44453	ORIG	2012-07-11
25329	SUPPL	2012-07-11
20768	SUPPL	2011-02-04
41484	SUPPL	2007-11-19
41483	SUPPL	2007-11-19
25328	SUPPL	2007-05-01
12854	SUPPL	2007-04-25
34960	SUPPL	2007-03-07
25327	SUPPL	2007-03-07
12853	SUPPL	2007-03-07
2882	SUPPL	2007-03-07
34961	SUPPL	2006-11-06
2883	SUPPL	2006-11-06
25326	SUPPL	2005-10-20
12852	SUPPL	2005-09-30