Application 076438

Type: ANDA
Sponsor: SPECGX LLC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	MORPHINE SULFATE	MORPHINE SULFATE	TABLET, EXTENDED RELEASE;ORAL	100MG	No	No
002	MORPHINE SULFATE	MORPHINE SULFATE	TABLET, EXTENDED RELEASE;ORAL	200MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A076438-001	MORPHINE SULFATE	MORPHINE SULFATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB		2003-07-03
A076438-002	MORPHINE SULFATE	MORPHINE SULFATE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB		2003-07-03

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A076438-001	AB
A076438-002	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 3 · 84 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
2026-08-18 06:07:40	2026-07	A076438-001	MORPHINE SULFATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2003-07-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076438-002	MORPHINE SULFATE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2003-07-03	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076438-001	MORPHINE SULFATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2003-07-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076438-002	MORPHINE SULFATE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2003-07-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076438-001	MORPHINE SULFATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2003-07-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076438-002	MORPHINE SULFATE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2003-07-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076438-001	MORPHINE SULFATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2003-07-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076438-002	MORPHINE SULFATE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2003-07-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076438-001	MORPHINE SULFATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2003-07-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076438-002	MORPHINE SULFATE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2003-07-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076438-001	MORPHINE SULFATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2003-07-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076438-002	MORPHINE SULFATE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2003-07-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076438-001	MORPHINE SULFATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2003-07-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076438-002	MORPHINE SULFATE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2003-07-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076438-001	MORPHINE SULFATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2003-07-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076438-002	MORPHINE SULFATE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2003-07-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076438-001	MORPHINE SULFATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2003-07-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076438-002	MORPHINE SULFATE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2003-07-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076438-001	MORPHINE SULFATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2003-07-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076438-002	MORPHINE SULFATE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2003-07-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076438-001	MORPHINE SULFATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2003-07-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076438-002	MORPHINE SULFATE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2003-07-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076438-001	MORPHINE SULFATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2003-07-03	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076438-002	MORPHINE SULFATE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2003-07-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076438-001	MORPHINE SULFATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2003-07-03	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076438-002	MORPHINE SULFATE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2003-07-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076438-001	MORPHINE SULFATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2003-07-03	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076438-002	MORPHINE SULFATE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2003-07-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076438-001	MORPHINE SULFATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2003-07-03	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A076438-002	MORPHINE SULFATE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2003-07-03	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076438-001	MORPHINE SULFATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2003-07-03	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076438-002	MORPHINE SULFATE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2003-07-03	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076438-001	MORPHINE SULFATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2003-07-03	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A076438-002	MORPHINE SULFATE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2003-07-03	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076438-001	MORPHINE SULFATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2003-07-03	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A076438-002	MORPHINE SULFATE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2003-07-03	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076438-001	MORPHINE SULFATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2003-07-03	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076438-002	MORPHINE SULFATE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2003-07-03	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076438-001	MORPHINE SULFATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2003-07-03	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A076438-002	MORPHINE SULFATE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2003-07-03	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A076438-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076438-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076438-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076438-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076438-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076438-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076438-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076438-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076438-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076438-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076438-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076438-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076438-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076438-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076438-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076438-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076438-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076438-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076438-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076438-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076438-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076438-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076438-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076438-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076438-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076438-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076438-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076438-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076438-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A076438-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076438-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076438-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076438-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A076438-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076438-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A076438-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076438-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076438-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076438-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A076438-002	AB	1	`bb7c543d1eb4…`

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	SpecGx LLC	533034fd-c8e7-495b-8874-0db41bd1e65a	2023-12-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076438 application number: ANDA076438 ndc (product): 0406-8320 ndc (product): 0406-8390

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 10 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0406-8320	MORPHINE SULFATE	MORPHINE SULFATE	SpecGx LLC	ANDA	Current
0406-8320	MORPHINE SULFATE	MORPHINE SULFATE	SpecGx LLC	ANDA	Current
0406-8320	MORPHINE SULFATE	MORPHINE SULFATE	SpecGx LLC	ANDA	Current
0406-8320	MORPHINE SULFATE	MORPHINE SULFATE	SpecGx LLC	ANDA	Current
0406-8320	MORPHINE SULFATE	MORPHINE SULFATE	SpecGx LLC	ANDA	Current
0406-8390	MORPHINE SULFATE	MORPHINE SULFATE	SpecGx LLC	ANDA	Current
0406-8390	MORPHINE SULFATE	MORPHINE SULFATE	SpecGx LLC	ANDA	Current
0406-8390	MORPHINE SULFATE	MORPHINE SULFATE	SpecGx LLC	ANDA	Current
0406-8390	MORPHINE SULFATE	MORPHINE SULFATE	SpecGx LLC	ANDA	Current
0406-8390	MORPHINE SULFATE	MORPHINE SULFATE	SpecGx LLC	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
44529	ORIG	2015-06-30