Application 203995

Type: ANDA
Sponsor: AMNEAL PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DICLOFENAC SODIUM AND MISOPROSTOL	DICLOFENAC SODIUM; MISOPROSTOL	TABLET, DELAYED RELEASE;ORAL	50MG;0.2MG	No	No
002	DICLOFENAC SODIUM AND MISOPROSTOL	DICLOFENAC SODIUM; MISOPROSTOL	TABLET, DELAYED RELEASE;ORAL	75MG;0.2MG	No	No

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

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
A203995-001	DICLOFENAC SODIUM AND MISOPROSTOL	DICLOFENAC SODIUM; MISOPROSTOL	50MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB		2016-11-25
A203995-002	DICLOFENAC SODIUM AND MISOPROSTOL	DICLOFENAC SODIUM; MISOPROSTOL	75MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB		2016-11-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A203995-001	AB
A203995-002	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 · 82 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
2026-02-19 14:30 UTC	2026-02	A203995-001	DICLOFENAC SODIUM AND MISOPROSTOL	50MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2016-11-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203995-002	DICLOFENAC SODIUM AND MISOPROSTOL	75MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2016-11-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203995-001	DICLOFENAC SODIUM AND MISOPROSTOL	50MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2016-11-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203995-002	DICLOFENAC SODIUM AND MISOPROSTOL	75MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2016-11-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203995-001	DICLOFENAC SODIUM AND MISOPROSTOL	50MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2016-11-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203995-002	DICLOFENAC SODIUM AND MISOPROSTOL	75MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2016-11-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203995-001	DICLOFENAC SODIUM AND MISOPROSTOL	50MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2016-11-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203995-002	DICLOFENAC SODIUM AND MISOPROSTOL	75MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2016-11-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203995-001	DICLOFENAC SODIUM AND MISOPROSTOL	50MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2016-11-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203995-002	DICLOFENAC SODIUM AND MISOPROSTOL	75MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2016-11-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203995-001	DICLOFENAC SODIUM AND MISOPROSTOL	50MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2016-11-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203995-002	DICLOFENAC SODIUM AND MISOPROSTOL	75MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2016-11-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203995-001	DICLOFENAC SODIUM AND MISOPROSTOL	50MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2016-11-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203995-002	DICLOFENAC SODIUM AND MISOPROSTOL	75MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2016-11-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203995-001	DICLOFENAC SODIUM AND MISOPROSTOL	50MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2016-11-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203995-002	DICLOFENAC SODIUM AND MISOPROSTOL	75MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2016-11-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203995-001	DICLOFENAC SODIUM AND MISOPROSTOL	50MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2016-11-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203995-002	DICLOFENAC SODIUM AND MISOPROSTOL	75MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2016-11-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203995-001	DICLOFENAC SODIUM AND MISOPROSTOL	50MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2016-11-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203995-002	DICLOFENAC SODIUM AND MISOPROSTOL	75MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2016-11-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203995-001	DICLOFENAC SODIUM AND MISOPROSTOL	50MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2016-11-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203995-002	DICLOFENAC SODIUM AND MISOPROSTOL	75MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2016-11-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203995-001	DICLOFENAC SODIUM AND MISOPROSTOL	50MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2016-11-25	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203995-002	DICLOFENAC SODIUM AND MISOPROSTOL	75MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2016-11-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203995-001	DICLOFENAC SODIUM AND MISOPROSTOL	50MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2016-11-25	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203995-002	DICLOFENAC SODIUM AND MISOPROSTOL	75MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2016-11-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203995-001	DICLOFENAC SODIUM AND MISOPROSTOL	50MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2016-11-25	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A203995-002	DICLOFENAC SODIUM AND MISOPROSTOL	75MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2016-11-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203995-001	DICLOFENAC SODIUM AND MISOPROSTOL	50MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2016-11-25	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203995-002	DICLOFENAC SODIUM AND MISOPROSTOL	75MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2016-11-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203995-001	DICLOFENAC SODIUM AND MISOPROSTOL	50MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2016-11-25	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A203995-002	DICLOFENAC SODIUM AND MISOPROSTOL	75MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2016-11-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203995-001	DICLOFENAC SODIUM AND MISOPROSTOL	50MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2016-11-25	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A203995-002	DICLOFENAC SODIUM AND MISOPROSTOL	75MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2016-11-25	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203995-001	DICLOFENAC SODIUM AND MISOPROSTOL	50MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2016-11-25	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A203995-002	DICLOFENAC SODIUM AND MISOPROSTOL	75MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2016-11-25	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203995-001	DICLOFENAC SODIUM AND MISOPROSTOL	50MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2016-11-25	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A203995-002	DICLOFENAC SODIUM AND MISOPROSTOL	75MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2016-11-25	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203995-001	DICLOFENAC SODIUM AND MISOPROSTOL	50MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2016-11-25	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A203995-002	DICLOFENAC SODIUM AND MISOPROSTOL	75MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2016-11-25	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A203995-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203995-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203995-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203995-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203995-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203995-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203995-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203995-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203995-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203995-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203995-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203995-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203995-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203995-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203995-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203995-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203995-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203995-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203995-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203995-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203995-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203995-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203995-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203995-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203995-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203995-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203995-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A203995-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203995-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203995-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203995-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A203995-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203995-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A203995-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203995-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A203995-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203995-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A203995-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203995-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A203995-002	AB	1	`782e0a99824c…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Diclofenac Sodium and Misoprostol	DICLOFENAC SODIUM AND MISOPROSTOL	Amneal Pharmaceuticals LLC	afd30051-8f59-474b-9972-962a5a871dfb	2025-04-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203995 application number: ANDA203995 ndc (product): 65162-436 ndc (product): 65162-438
Diclofenac Sodium and Misoprostol	DICLOFENAC SODIUM AND MISOPROSTOL	Bryant Ranch Prepack	d6671b66-00ad-4949-b51a-36e1130b1cb5	2025-01-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203995 application number: ANDA203995 ndc (product): 71335-1183

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 19 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50090-4618	Diclofenac Sodium and Misoprostol	Diclofenac Sodium and Misoprostol	A-S Medication Solutions	ANDA	Current
50090-4618	Diclofenac Sodium and Misoprostol	Diclofenac Sodium and Misoprostol	A-S Medication Solutions	ANDA	Current
65162-436	Diclofenac Sodium and Misoprostol	Diclofenac Sodium and Misoprostol	Amneal Pharmaceuticals LLC	ANDA	Current
65162-436	Diclofenac Sodium and Misoprostol	Diclofenac Sodium and Misoprostol	Amneal Pharmaceuticals LLC	ANDA	Current
65162-436	Diclofenac Sodium and Misoprostol	Diclofenac Sodium and Misoprostol	Amneal Pharmaceuticals LLC	ANDA	Current
65162-436	Diclofenac Sodium and Misoprostol	Diclofenac Sodium and Misoprostol	Amneal Pharmaceuticals LLC	ANDA	Current
65162-436	Diclofenac Sodium and Misoprostol	Diclofenac Sodium and Misoprostol	Amneal Pharmaceuticals LLC	ANDA	Current
65162-436	Diclofenac Sodium and Misoprostol	Diclofenac Sodium and Misoprostol	Amneal Pharmaceuticals LLC	ANDA	Current
65162-438	Diclofenac Sodium and Misoprostol	Diclofenac Sodium and Misoprostol	Amneal Pharmaceuticals LLC	ANDA	Current
65162-438	Diclofenac Sodium and Misoprostol	Diclofenac Sodium and Misoprostol	Amneal Pharmaceuticals LLC	ANDA	Current
65162-438	Diclofenac Sodium and Misoprostol	Diclofenac Sodium and Misoprostol	Amneal Pharmaceuticals LLC	ANDA	Current
65162-438	Diclofenac Sodium and Misoprostol	Diclofenac Sodium and Misoprostol	Amneal Pharmaceuticals LLC	ANDA	Current
65162-438	Diclofenac Sodium and Misoprostol	Diclofenac Sodium and Misoprostol	Amneal Pharmaceuticals LLC	ANDA	Current
65162-438	Diclofenac Sodium and Misoprostol	Diclofenac Sodium and Misoprostol	Amneal Pharmaceuticals LLC	ANDA	Current
68788-7103	Diclofenac Sodium and Misoprostol	Diclofenac Sodium and Misoprostol	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7103	Diclofenac Sodium and Misoprostol	Diclofenac Sodium and Misoprostol	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7103	Diclofenac Sodium and Misoprostol	Diclofenac Sodium and Misoprostol	Preferred Pharmaceuticals Inc.	ANDA	Current
71335-1183	Diclofenac Sodium and Misoprostol	Diclofenac Sodium and Misoprostol	Bryant Ranch Prepack	ANDA	Current
71335-1183	Diclofenac Sodium and Misoprostol	Diclofenac Sodium and Misoprostol	Bryant Ranch Prepack	ANDA	Current