Application 203602

Type: ANDA
Sponsor: NOVEL LABS INC

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
A203602-001	MORPHINE SULFATE	MORPHINE SULFATE	15MG	TABLET, EXTENDED RELEASE / ORAL	2015-12-16
A203602-002	MORPHINE SULFATE	MORPHINE SULFATE	30MG	TABLET, EXTENDED RELEASE / ORAL	2015-12-16
A203602-003	MORPHINE SULFATE	MORPHINE SULFATE	60MG	TABLET, EXTENDED RELEASE / ORAL	2015-12-16
A203602-004	MORPHINE SULFATE	MORPHINE SULFATE	100MG	TABLET, EXTENDED RELEASE / ORAL	2015-12-16
A203602-005	MORPHINE SULFATE	MORPHINE SULFATE	200MG	TABLET, EXTENDED RELEASE / ORAL	2015-12-16

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 2 of 6 · 215 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
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203602-001	MORPHINE SULFATE	15MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-12-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203602-002	MORPHINE SULFATE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-12-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203602-003	MORPHINE SULFATE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-12-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203602-004	MORPHINE SULFATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-12-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203602-005	MORPHINE SULFATE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-12-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203602-001	MORPHINE SULFATE	15MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-12-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203602-002	MORPHINE SULFATE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-12-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203602-003	MORPHINE SULFATE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-12-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203602-004	MORPHINE SULFATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-12-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203602-005	MORPHINE SULFATE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-12-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203602-001	MORPHINE SULFATE	15MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-12-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203602-002	MORPHINE SULFATE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-12-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203602-003	MORPHINE SULFATE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-12-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203602-004	MORPHINE SULFATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-12-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203602-005	MORPHINE SULFATE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-12-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203602-001	MORPHINE SULFATE	15MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-12-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203602-002	MORPHINE SULFATE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-12-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203602-003	MORPHINE SULFATE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-12-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203602-004	MORPHINE SULFATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-12-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203602-005	MORPHINE SULFATE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-12-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203602-001	MORPHINE SULFATE	15MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-12-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203602-002	MORPHINE SULFATE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-12-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203602-003	MORPHINE SULFATE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-12-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203602-004	MORPHINE SULFATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-12-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203602-005	MORPHINE SULFATE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-12-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203602-001	MORPHINE SULFATE	15MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-12-16	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203602-002	MORPHINE SULFATE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-12-16	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203602-003	MORPHINE SULFATE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-12-16	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203602-004	MORPHINE SULFATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-12-16	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203602-005	MORPHINE SULFATE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-12-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203602-001	MORPHINE SULFATE	15MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-12-16	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203602-002	MORPHINE SULFATE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-12-16	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203602-003	MORPHINE SULFATE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-12-16	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203602-004	MORPHINE SULFATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-12-16	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203602-005	MORPHINE SULFATE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-12-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203602-001	MORPHINE SULFATE	15MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-12-16	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A203602-002	MORPHINE SULFATE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-12-16	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A203602-003	MORPHINE SULFATE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-12-16	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A203602-004	MORPHINE SULFATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-12-16	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A203602-005	MORPHINE SULFATE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-12-16	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 180 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203602-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203602-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203602-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203602-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203602-005	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203602-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203602-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203602-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203602-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203602-005	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203602-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203602-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203602-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203602-004	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203602-005	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203602-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203602-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203602-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203602-004	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203602-005	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203602-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203602-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203602-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203602-004	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203602-005	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203602-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203602-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203602-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203602-004	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203602-005	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203602-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203602-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203602-003	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203602-004	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203602-005	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203602-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203602-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203602-003	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203602-004	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203602-005	AB	1	`301d65b070ca…`

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	Lupin Pharmaceuticals,Inc.	d360a33f-6323-4b10-9e81-07e2813c2dbd	2024-02-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203602 application number: ANDA203602 ndc (product): 43386-544 ndc (product): 43386-543 ndc (product): 43386-541 ndc (product): 43386-540 ndc (product): 43386-542

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 · 20 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
40032-540	Morphine Sulfate	Morphine Sulfate	Novel Laboratories, Inc.	ANDA	Current
40032-540	Morphine Sulfate	Morphine Sulfate	Novel Laboratories, Inc.	ANDA	Current
40032-541	Morphine Sulfate	Morphine Sulfate	Novel Laboratories, Inc.	ANDA	Current
40032-541	Morphine Sulfate	Morphine Sulfate	Novel Laboratories, Inc.	ANDA	Current
40032-542	Morphine Sulfate	Morphine Sulfate	Novel Laboratories, Inc.	ANDA	Current
40032-542	Morphine Sulfate	Morphine Sulfate	Novel Laboratories, Inc.	ANDA	Current
40032-543	Morphine Sulfate	Morphine Sulfate	Novel Laboratories, Inc.	ANDA	Current
40032-543	Morphine Sulfate	Morphine Sulfate	Novel Laboratories, Inc.	ANDA	Current
40032-544	Morphine Sulfate	Morphine Sulfate	Novel Laboratories, Inc.	ANDA	Current
40032-544	Morphine Sulfate	Morphine Sulfate	Novel Laboratories, Inc.	ANDA	Current
43386-540	Morphine Sulfate	Morphine Sulfate	Lupin Pharmaceuticals,Inc.	ANDA	Current
43386-540	Morphine Sulfate	Morphine Sulfate	Lupin Pharmaceuticals,Inc.	ANDA	Current
43386-541	Morphine Sulfate	Morphine Sulfate	Lupin Pharmaceuticals,Inc.	ANDA	Current
43386-541	Morphine Sulfate	Morphine Sulfate	Lupin Pharmaceuticals,Inc.	ANDA	Current
43386-542	Morphine Sulfate	Morphine Sulfate	Lupin Pharmaceuticals,Inc.	ANDA	Current
43386-542	Morphine Sulfate	Morphine Sulfate	Lupin Pharmaceuticals,Inc.	ANDA	Current
43386-543	Morphine Sulfate	Morphine Sulfate	Lupin Pharmaceuticals,Inc.	ANDA	Current
43386-543	Morphine Sulfate	Morphine Sulfate	Lupin Pharmaceuticals,Inc.	ANDA	Current
43386-544	Morphine Sulfate	Morphine Sulfate	Lupin Pharmaceuticals,Inc.	ANDA	Current
43386-544	Morphine Sulfate	Morphine Sulfate	Lupin Pharmaceuticals,Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
76292	ORIG	2023-11-03
32453	ORIG	2015-12-18