Application 202861

Type: ANDA
Sponsor: INTL MEDICATION SYS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	MORPHINE SULFATE	MORPHINE SULFATE	INJECTABLE;INJECTION	1MG/ML	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A202861-001	MORPHINE SULFATE	MORPHINE SULFATE	1MG/ML	INJECTABLE / INJECTION			2021-04-29

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.

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	A202861-001	MORPHINE SULFATE	1MG/ML	INJECTABLE / INJECTION	2021-04-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202861-001	MORPHINE SULFATE	1MG/ML	INJECTABLE / INJECTION	2021-04-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202861-001	MORPHINE SULFATE	1MG/ML	INJECTABLE / INJECTION	2021-04-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202861-001	MORPHINE SULFATE	1MG/ML	INJECTABLE / INJECTION	2021-04-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202861-001	MORPHINE SULFATE	1MG/ML	INJECTABLE / INJECTION	2021-04-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202861-001	MORPHINE SULFATE	1MG/ML	INJECTABLE / INJECTION	2021-04-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202861-001	MORPHINE SULFATE	1MG/ML	INJECTABLE / INJECTION	2021-04-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202861-001	MORPHINE SULFATE	1MG/ML	INJECTABLE / INJECTION	2021-04-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202861-001	MORPHINE SULFATE	1MG/ML	INJECTABLE / INJECTION	2021-04-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202861-001	MORPHINE SULFATE	1MG/ML	INJECTABLE / INJECTION	2021-04-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202861-001	MORPHINE SULFATE	1MG/ML	INJECTABLE / INJECTION	2021-04-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202861-001	MORPHINE SULFATE	1MG/ML	INJECTABLE / INJECTION	2021-04-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202861-001	MORPHINE SULFATE	1MG/ML	INJECTABLE / INJECTION	2021-04-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202861-001	MORPHINE SULFATE	1MG/ML	INJECTABLE / INJECTION	2021-04-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202861-001	MORPHINE SULFATE	1MG/ML	INJECTABLE / INJECTION	2021-04-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202861-001	MORPHINE SULFATE	1MG/ML	INJECTABLE / INJECTION	2021-04-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202861-001	MORPHINE SULFATE	1MG/ML	INJECTABLE / INJECTION	2021-04-29	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A202861-001	MORPHINE SULFATE	1MG/ML	INJECTABLE / INJECTION	2021-04-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202861-001	MORPHINE SULFATE	1MG/ML	INJECTABLE / INJECTION	2021-04-29	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202861-001	MORPHINE SULFATE	1MG/ML	INJECTABLE / INJECTION	2021-04-29	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A202861-001	MORPHINE SULFATE	1MG/ML	INJECTABLE / INJECTION	2021-04-29	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A202861-001	MORPHINE SULFATE	1MG/ML	INJECTABLE / INJECTION	2021-04-29	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A202861-001	MORPHINE SULFATE	1MG/ML	INJECTABLE / INJECTION	2021-04-29	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A202861-001	MORPHINE SULFATE	1MG/ML	INJECTABLE / INJECTION	2021-04-29	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A202861-001	MORPHINE SULFATE	1MG/ML	INJECTABLE / INJECTION	2021-04-29	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A202861-001	MORPHINE SULFATE	1MG/ML	INJECTABLE / INJECTION	2021-04-29	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A202861-001	MORPHINE SULFATE	1MG/ML	INJECTABLE / INJECTION	2021-04-29	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A202861-001	MORPHINE SULFATE	1MG/ML	INJECTABLE / INJECTION	2021-04-29	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A202861-001	MORPHINE SULFATE	1MG/ML	INJECTABLE / INJECTION	2021-04-29	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A202861-001	MORPHINE SULFATE	1MG/ML	INJECTABLE / INJECTION	2021-04-29	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A202861-001	MORPHINE SULFATE	1MG/ML	INJECTABLE / INJECTION	2021-04-29	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A202861-001	MORPHINE SULFATE	1MG/ML	INJECTABLE / INJECTION	2021-04-29	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A202861-001	MORPHINE SULFATE	1MG/ML	INJECTABLE / INJECTION	2021-04-29	`a50c72e98297…`

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 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Morphine Sulfate	MORPHINE SULFATE	International Medication Systems, Limited	1034467f-d436-4b87-a902-c7e8885daa8a	2024-12-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202861 application number: ANDA202861 ndc (product): 76329-1912

NDC Listings For This Application#

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

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
76329-1912	Morphine Sulfate	Morphine Sulfate	International Medication Systems, Limited	ANDA	Current
76329-1912	Morphine Sulfate	Morphine Sulfate	International Medication Systems, Limited	ANDA	Current