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 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 brand name: Morphine Sulfate 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 brand name: Morphine Sulfate 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 brand name: Morphine Sulfate 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 brand name: Morphine Sulfate 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 brand name: Morphine Sulfate 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 brand name: MORPHINE SULFATE 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 brand name: Morphine Sulfate 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 brand name: Morphine sulfate 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 brand name: Morphine Sulfate 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 brand name: Morphine Sulfate 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 brand name: MORPHINE SULFATE 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 brand name: Morphine Sulfate 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 brand name: Morphine Sulfate 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 brand name: Morphine Sulfate 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 brand name: Morphine sulfate 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 brand name: Morphine sulfate 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 brand name: Morphine sulfate 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 brand name: Morphine sulfate 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