Application 205634

Type: ANDA
Sponsor: SUN PHARM INDUSTRIES

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	MORPHINE SULFATE	MORPHINE SULFATE	TABLET, EXTENDED RELEASE;ORAL	15MG	No	No
002	MORPHINE SULFATE	MORPHINE SULFATE	TABLET, EXTENDED RELEASE;ORAL	30MG	No	No
003	MORPHINE SULFATE	MORPHINE SULFATE	TABLET, EXTENDED RELEASE;ORAL	60MG	No	No
004	MORPHINE SULFATE	MORPHINE SULFATE	TABLET, EXTENDED RELEASE;ORAL	100MG	No	No
005	MORPHINE SULFATE	MORPHINE SULFATE	TABLET, EXTENDED RELEASE;ORAL	200MG	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A205634-001	MORPHINE SULFATE	MORPHINE SULFATE	15MG	TABLET, EXTENDED RELEASE / ORAL	2016-08-25
A205634-002	MORPHINE SULFATE	MORPHINE SULFATE	30MG	TABLET, EXTENDED RELEASE / ORAL	2016-08-25
A205634-003	MORPHINE SULFATE	MORPHINE SULFATE	60MG	TABLET, EXTENDED RELEASE / ORAL	2016-08-25
A205634-004	MORPHINE SULFATE	MORPHINE SULFATE	100MG	TABLET, EXTENDED RELEASE / ORAL	2016-08-25
A205634-005	MORPHINE SULFATE	MORPHINE SULFATE	200MG	TABLET, EXTENDED RELEASE / ORAL	2016-08-25

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 6 · 215 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	A205634-001	MORPHINE SULFATE	15MG	TABLET, EXTENDED RELEASE / ORAL	2016-08-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A205634-002	MORPHINE SULFATE	30MG	TABLET, EXTENDED RELEASE / ORAL	2016-08-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A205634-003	MORPHINE SULFATE	60MG	TABLET, EXTENDED RELEASE / ORAL	2016-08-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A205634-004	MORPHINE SULFATE	100MG	TABLET, EXTENDED RELEASE / ORAL	2016-08-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A205634-005	MORPHINE SULFATE	200MG	TABLET, EXTENDED RELEASE / ORAL	2016-08-25	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A205634-001	MORPHINE SULFATE	15MG	TABLET, EXTENDED RELEASE / ORAL	2016-08-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205634-002	MORPHINE SULFATE	30MG	TABLET, EXTENDED RELEASE / ORAL	2016-08-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205634-003	MORPHINE SULFATE	60MG	TABLET, EXTENDED RELEASE / ORAL	2016-08-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205634-004	MORPHINE SULFATE	100MG	TABLET, EXTENDED RELEASE / ORAL	2016-08-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205634-005	MORPHINE SULFATE	200MG	TABLET, EXTENDED RELEASE / ORAL	2016-08-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A205634-001	MORPHINE SULFATE	15MG	TABLET, EXTENDED RELEASE / ORAL	2016-08-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205634-002	MORPHINE SULFATE	30MG	TABLET, EXTENDED RELEASE / ORAL	2016-08-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205634-003	MORPHINE SULFATE	60MG	TABLET, EXTENDED RELEASE / ORAL	2016-08-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205634-004	MORPHINE SULFATE	100MG	TABLET, EXTENDED RELEASE / ORAL	2016-08-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205634-005	MORPHINE SULFATE	200MG	TABLET, EXTENDED RELEASE / ORAL	2016-08-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205634-001	MORPHINE SULFATE	15MG	TABLET, EXTENDED RELEASE / ORAL	2016-08-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205634-002	MORPHINE SULFATE	30MG	TABLET, EXTENDED RELEASE / ORAL	2016-08-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205634-003	MORPHINE SULFATE	60MG	TABLET, EXTENDED RELEASE / ORAL	2016-08-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205634-004	MORPHINE SULFATE	100MG	TABLET, EXTENDED RELEASE / ORAL	2016-08-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205634-005	MORPHINE SULFATE	200MG	TABLET, EXTENDED RELEASE / ORAL	2016-08-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205634-001	MORPHINE SULFATE	15MG	TABLET, EXTENDED RELEASE / ORAL	2016-08-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205634-002	MORPHINE SULFATE	30MG	TABLET, EXTENDED RELEASE / ORAL	2016-08-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205634-003	MORPHINE SULFATE	60MG	TABLET, EXTENDED RELEASE / ORAL	2016-08-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205634-004	MORPHINE SULFATE	100MG	TABLET, EXTENDED RELEASE / ORAL	2016-08-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205634-005	MORPHINE SULFATE	200MG	TABLET, EXTENDED RELEASE / ORAL	2016-08-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205634-001	MORPHINE SULFATE	15MG	TABLET, EXTENDED RELEASE / ORAL	2016-08-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205634-002	MORPHINE SULFATE	30MG	TABLET, EXTENDED RELEASE / ORAL	2016-08-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205634-003	MORPHINE SULFATE	60MG	TABLET, EXTENDED RELEASE / ORAL	2016-08-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205634-004	MORPHINE SULFATE	100MG	TABLET, EXTENDED RELEASE / ORAL	2016-08-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205634-005	MORPHINE SULFATE	200MG	TABLET, EXTENDED RELEASE / ORAL	2016-08-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205634-001	MORPHINE SULFATE	15MG	TABLET, EXTENDED RELEASE / ORAL	2016-08-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205634-002	MORPHINE SULFATE	30MG	TABLET, EXTENDED RELEASE / ORAL	2016-08-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205634-003	MORPHINE SULFATE	60MG	TABLET, EXTENDED RELEASE / ORAL	2016-08-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205634-004	MORPHINE SULFATE	100MG	TABLET, EXTENDED RELEASE / ORAL	2016-08-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205634-005	MORPHINE SULFATE	200MG	TABLET, EXTENDED RELEASE / ORAL	2016-08-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205634-001	MORPHINE SULFATE	15MG	TABLET, EXTENDED RELEASE / ORAL	2016-08-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205634-002	MORPHINE SULFATE	30MG	TABLET, EXTENDED RELEASE / ORAL	2016-08-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205634-003	MORPHINE SULFATE	60MG	TABLET, EXTENDED RELEASE / ORAL	2016-08-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205634-004	MORPHINE SULFATE	100MG	TABLET, EXTENDED RELEASE / ORAL	2016-08-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205634-005	MORPHINE SULFATE	200MG	TABLET, EXTENDED RELEASE / ORAL	2016-08-25	`03ed91905a0d…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-09-15 20:21 UTC	2019-09	A205634-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A205634-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A205634-003	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A205634-004	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A205634-005	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A205634-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A205634-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A205634-003	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A205634-004	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A205634-005	AB	1	`ea99ee380514…`

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 2 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	American Health Packaging	5422cdac-8073-41fc-8665-ffe9797f5c02	2026-05-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Morphine Sulfate 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 brand name: Morphine Sulfate 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 brand name: MORPHINE SULFATE 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
Morphine Sulfate	MORPHINE SULFATE	Bryant Ranch Prepack	cc3b491c-a206-3027-54f0-f87c0dd40a7f	2026-04-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Morphine Sulfate generic name: MORPHINE SULFATE
Morphine sulfate	MORPHINE SULFATE	Sun Pharmaceutical Industries, Inc.	736c9b80-682c-4cda-bf18-61b18de0bd39	2026-03-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Morphine sulfate generic name: MORPHINE SULFATE
Morphine sulfate	MORPHINE SULFATE	Actavis Pharma, Inc.	2da87bfa-11fd-43e3-8fef-d16ebeb15680	2026-03-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Morphine sulfate generic name: MORPHINE SULFATE
MITIGO	MORPHINE SULFATE	Piramal Critical Care, Inc.	728f3d83-9a63-0c1f-e053-2a91aa0ac7db	2026-02-19	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MORPHINE SULFATE
Morphine Sulfate	MORPHINE SULFATE	Cranbury Pharmaceuticals, LLC	d8598654-94ad-4cfb-81d2-9b68e013a428	2026-02-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Morphine Sulfate generic name: MORPHINE SULFATE
Morphine sulfate	MORPHINE SULFATE	Bryant Ranch Prepack	07993f6c-146b-4728-a2da-6e93089f78ff	2026-02-13	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Morphine sulfate generic name: MORPHINE SULFATE
Morphine Sulfate	MORPHINE SULFATE	American Health Packaging	66a3f607-7f48-490f-84dd-b74dd1ee39e5	2026-02-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Morphine Sulfate generic name: MORPHINE SULFATE
Morphine Sulfate	MORPHINE SULFATE	Hikma Pharmaceuticals USA Inc.	ca359246-4674-4b32-b8b2-673d32b7112f	2026-02-03	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Morphine Sulfate generic name: MORPHINE SULFATE
Morphine Sulfate	MORPHINE SULFATE	Hikma Pharmaceuticals USA Inc.	3c847554-3b4b-4d24-a145-2ef7e9b83699	2026-02-03	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Morphine Sulfate generic name: MORPHINE SULFATE
Morphine sulfate	MORPHINE SULFATE	Bryant Ranch Prepack	3a89d0ca-4ff8-4bdc-8ea8-9ad591ce7226	2026-01-22	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Morphine sulfate generic name: MORPHINE SULFATE
Morphine Sulfate	MORPHINE SULFATE	PAI Holdings, LLC dba PAI Pharma	9405556c-20e0-4e47-b1b0-7872bcc6517e	2026-01-13	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Morphine Sulfate generic name: MORPHINE SULFATE
Morphine Sulfate	MORPHINE SULFATE	Hospira, Inc.	be420e8b-bcb0-49b5-bb4d-1df8b9959809	2025-12-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Morphine Sulfate generic name: MORPHINE SULFATE
Morphine Sulfate	MORPHINE SULFATE	Hospira, Inc.	ee8057d1-ed12-4e18-9efa-d83504abf612	2025-12-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Morphine Sulfate generic name: MORPHINE SULFATE
Duramorph	MORPHINE SULFATE	Hikma Pharmaceuticals USA Inc.	ebb18761-e5c4-4238-bb84-f9549f500210	2025-12-31	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 1 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
57664-190	Morphine Sulfate Extended-Release	Morphine Sulfate Extended-Release	Sun Pharmaceutical Industries, Inc.	ANDA	Current
57664-191	Morphine Sulfate Extended-Release	Morphine Sulfate Extended-Release	Sun Pharmaceutical Industries, Inc.	ANDA	Current
57664-192	Morphine Sulfate Extended-Release	Morphine Sulfate Extended-Release	Sun Pharmaceutical Industries, Inc.	ANDA	Current
57664-196	Morphine Sulfate Extended-Release	Morphine Sulfate Extended-Release	Sun Pharmaceutical Industries, Inc.	ANDA	Current
57664-197	Morphine Sulfate Extended-Release	Morphine Sulfate Extended-Release	Sun Pharmaceutical Industries, Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
76293	ORIG	2023-11-03
45820	APPL	2016-11-04