Application 212451

Type: ANDA
Sponsor: ALKEM LABS LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	MORPHINE SULFATE	MORPHINE SULFATE	TABLET;ORAL	15MG	No	No
002	MORPHINE SULFATE	MORPHINE SULFATE	TABLET;ORAL	30MG	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A212451-001	MORPHINE SULFATE	MORPHINE SULFATE	15MG	TABLET / ORAL	AB		2020-12-03
A212451-002	MORPHINE SULFATE	MORPHINE SULFATE	30MG	TABLET / ORAL	AB		2020-12-03

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A212451-001	AB
A212451-002	AB

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 2 · 76 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A212451-001	MORPHINE SULFATE	15MG	TABLET / ORAL	AB	2020-12-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A212451-002	MORPHINE SULFATE	30MG	TABLET / ORAL	AB	2020-12-03	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A212451-001	MORPHINE SULFATE	15MG	TABLET / ORAL	AB	2020-12-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212451-002	MORPHINE SULFATE	30MG	TABLET / ORAL	AB	2020-12-03	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212451-001	MORPHINE SULFATE	15MG	TABLET / ORAL	AB	2020-12-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212451-002	MORPHINE SULFATE	30MG	TABLET / ORAL	AB	2020-12-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212451-001	MORPHINE SULFATE	15MG	TABLET / ORAL	AB	2020-12-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212451-002	MORPHINE SULFATE	30MG	TABLET / ORAL	AB	2020-12-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212451-001	MORPHINE SULFATE	15MG	TABLET / ORAL	AB	2020-12-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212451-002	MORPHINE SULFATE	30MG	TABLET / ORAL	AB	2020-12-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212451-001	MORPHINE SULFATE	15MG	TABLET / ORAL	AB	2020-12-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212451-002	MORPHINE SULFATE	30MG	TABLET / ORAL	AB	2020-12-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212451-001	MORPHINE SULFATE	15MG	TABLET / ORAL	AB	2020-12-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212451-002	MORPHINE SULFATE	30MG	TABLET / ORAL	AB	2020-12-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212451-001	MORPHINE SULFATE	15MG	TABLET / ORAL	AB	2020-12-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212451-002	MORPHINE SULFATE	30MG	TABLET / ORAL	AB	2020-12-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212451-001	MORPHINE SULFATE	15MG	TABLET / ORAL	AB	2020-12-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212451-002	MORPHINE SULFATE	30MG	TABLET / ORAL	AB	2020-12-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212451-001	MORPHINE SULFATE	15MG	TABLET / ORAL	AB	2020-12-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212451-002	MORPHINE SULFATE	30MG	TABLET / ORAL	AB	2020-12-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212451-001	MORPHINE SULFATE	15MG	TABLET / ORAL	AB	2020-12-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212451-002	MORPHINE SULFATE	30MG	TABLET / ORAL	AB	2020-12-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212451-001	MORPHINE SULFATE	15MG	TABLET / ORAL	AB	2020-12-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212451-002	MORPHINE SULFATE	30MG	TABLET / ORAL	AB	2020-12-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212451-001	MORPHINE SULFATE	15MG	TABLET / ORAL	AB	2020-12-03	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212451-002	MORPHINE SULFATE	30MG	TABLET / ORAL	AB	2020-12-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212451-001	MORPHINE SULFATE	15MG	TABLET / ORAL	AB	2020-12-03	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212451-002	MORPHINE SULFATE	30MG	TABLET / ORAL	AB	2020-12-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212451-001	MORPHINE SULFATE	15MG	TABLET / ORAL	AB	2020-12-03	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212451-002	MORPHINE SULFATE	30MG	TABLET / ORAL	AB	2020-12-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212451-001	MORPHINE SULFATE	15MG	TABLET / ORAL	AB	2020-12-03	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A212451-002	MORPHINE SULFATE	30MG	TABLET / ORAL	AB	2020-12-03	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212451-001	MORPHINE SULFATE	15MG	TABLET / ORAL	AB	2020-12-03	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212451-002	MORPHINE SULFATE	30MG	TABLET / ORAL	AB	2020-12-03	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212451-001	MORPHINE SULFATE	15MG	TABLET / ORAL	AB	2020-12-03	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A212451-002	MORPHINE SULFATE	30MG	TABLET / ORAL	AB	2020-12-03	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212451-001	MORPHINE SULFATE	15MG	TABLET / ORAL	AB	2020-12-03	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A212451-002	MORPHINE SULFATE	30MG	TABLET / ORAL	AB	2020-12-03	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A212451-001	MORPHINE SULFATE	15MG	TABLET / ORAL	AB	2020-12-03	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A212451-002	MORPHINE SULFATE	30MG	TABLET / ORAL	AB	2020-12-03	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 76 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A212451-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A212451-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A212451-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212451-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212451-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212451-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212451-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212451-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212451-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212451-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212451-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212451-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212451-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212451-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212451-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212451-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212451-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212451-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212451-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212451-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212451-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212451-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212451-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212451-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212451-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212451-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212451-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212451-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212451-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212451-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212451-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A212451-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212451-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212451-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212451-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A212451-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212451-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A212451-002	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A212451-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A212451-002	AB	1	`bb7c543d1eb4…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2021-12-28 21:50 UTC	2021-12	A212451-001	CGT	2021-08-10	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A212451-002	CGT	2021-08-10	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A212451-001	CGT	2021-08-10	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A212451-002	CGT	2021-08-10	`87673890dc5c…`

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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
MORPHINE SULFATE	MORPHINE SULFATE	St. Mary's Medical Park Pharmacy	57ee014e-744e-65e1-e063-6394a90a8c93	2026-07-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212451 application number: ANDA212451
MORPHINE SULFATE	MORPHINE SULFATE	Bryant Ranch Prepack	d1b0b4ac-69d9-44bf-b7a3-229bd89b9fd6	2026-04-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212451 application number: ANDA212451
Morphine Sulfate	MORPHINE SULFATE	American Health Packaging	d66d0cfb-9bfe-490c-90ee-49481c567e85	2025-12-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212451 application number: ANDA212451 ndc (product): 60687-617
MORPHINE SULFATE	MORPHINE SULFATE	Ascend Laboratories, LLC	07593aa4-f2c4-4d6e-b186-ab2a4ecaa38a	2025-10-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212451 application number: ANDA212451 ndc (product): 67877-671 ndc (product): 67877-670
MORPHINE SULFATE	MORPHINE SULFATE	Bryant Ranch Prepack	905cd842-2c86-4318-a6c4-92f49de145b3	2025-06-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212451 application number: ANDA212451 ndc (product): 63629-8459

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 · 15 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
55700-905	MORPHINE SULFATE	MORPHINE SULFATE	Quality Care Products, LLC	ANDA	Current
55700-905	MORPHINE SULFATE	MORPHINE SULFATE	Quality Care Products, LLC	ANDA	Current
55700-905	MORPHINE SULFATE	MORPHINE SULFATE	Quality Care Products, LLC	ANDA	Current
60687-617	MORPHINE SULFATE	MORPHINE SULFATE	American Health Packaging	ANDA	Current
60687-617	Morphine Sulfate	Morphine Sulfate	American Health Packaging	ANDA	Current
63629-8459	MORPHINE SULFATE	MORPHINE SULFATE	Bryant Ranch Prepack	ANDA	Current
63629-8459	MORPHINE SULFATE	MORPHINE SULFATE	Bryant Ranch Prepack	ANDA	Current
63629-8460	MORPHINE SULFATE	MORPHINE SULFATE	Bryant Ranch Prepack	ANDA	Current
63629-8460	MORPHINE SULFATE	MORPHINE SULFATE	Bryant Ranch Prepack	ANDA	Current
67877-670	MORPHINE SULFATE	MORPHINE SULFATE	Ascend Laboratories, LLC	ANDA	Current
67877-670	MORPHINE SULFATE	MORPHINE SULFATE	Ascend Laboratories, LLC	ANDA	Current
67877-670	MORPHINE SULFATE	MORPHINE SULFATE	Ascend Laboratories, LLC	ANDA	Current
67877-671	MORPHINE SULFATE	MORPHINE SULFATE	Ascend Laboratories, LLC	ANDA	Current
67877-671	MORPHINE SULFATE	MORPHINE SULFATE	Ascend Laboratories, LLC	ANDA	Current
67877-671	MORPHINE SULFATE	MORPHINE SULFATE	Ascend Laboratories, LLC	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
76467	ORIG	2023-11-07
65854	ORIG	2021-01-07