Application 205143

Type: ANDA
Sponsor: YUNG SHIN PHARM

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 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
A205143-001	DICLOFENAC SODIUM AND MISOPROSTOL	DICLOFENAC SODIUM; MISOPROSTOL	50MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB		2020-02-19
A205143-002	DICLOFENAC SODIUM AND MISOPROSTOL	DICLOFENAC SODIUM; MISOPROSTOL	75MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB		2020-02-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A205143-001	AB
A205143-002	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 · 78 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	A205143-001	DICLOFENAC SODIUM AND MISOPROSTOL	50MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2020-02-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A205143-002	DICLOFENAC SODIUM AND MISOPROSTOL	75MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2020-02-19	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A205143-001	DICLOFENAC SODIUM AND MISOPROSTOL	50MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2020-02-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205143-002	DICLOFENAC SODIUM AND MISOPROSTOL	75MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2020-02-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A205143-001	DICLOFENAC SODIUM AND MISOPROSTOL	50MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2020-02-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205143-002	DICLOFENAC SODIUM AND MISOPROSTOL	75MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2020-02-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205143-001	DICLOFENAC SODIUM AND MISOPROSTOL	50MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2020-02-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205143-002	DICLOFENAC SODIUM AND MISOPROSTOL	75MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2020-02-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205143-001	DICLOFENAC SODIUM AND MISOPROSTOL	50MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2020-02-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205143-002	DICLOFENAC SODIUM AND MISOPROSTOL	75MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2020-02-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205143-001	DICLOFENAC SODIUM AND MISOPROSTOL	50MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2020-02-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205143-002	DICLOFENAC SODIUM AND MISOPROSTOL	75MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2020-02-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205143-001	DICLOFENAC SODIUM AND MISOPROSTOL	50MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2020-02-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205143-002	DICLOFENAC SODIUM AND MISOPROSTOL	75MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2020-02-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205143-001	DICLOFENAC SODIUM AND MISOPROSTOL	50MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2020-02-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205143-002	DICLOFENAC SODIUM AND MISOPROSTOL	75MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2020-02-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205143-001	DICLOFENAC SODIUM AND MISOPROSTOL	50MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2020-02-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205143-002	DICLOFENAC SODIUM AND MISOPROSTOL	75MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2020-02-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205143-001	DICLOFENAC SODIUM AND MISOPROSTOL	50MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2020-02-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205143-002	DICLOFENAC SODIUM AND MISOPROSTOL	75MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2020-02-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205143-001	DICLOFENAC SODIUM AND MISOPROSTOL	50MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2020-02-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205143-002	DICLOFENAC SODIUM AND MISOPROSTOL	75MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2020-02-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205143-001	DICLOFENAC SODIUM AND MISOPROSTOL	50MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2020-02-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205143-002	DICLOFENAC SODIUM AND MISOPROSTOL	75MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2020-02-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205143-001	DICLOFENAC SODIUM AND MISOPROSTOL	50MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2020-02-19	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205143-002	DICLOFENAC SODIUM AND MISOPROSTOL	75MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2020-02-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205143-001	DICLOFENAC SODIUM AND MISOPROSTOL	50MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2020-02-19	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205143-002	DICLOFENAC SODIUM AND MISOPROSTOL	75MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2020-02-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205143-001	DICLOFENAC SODIUM AND MISOPROSTOL	50MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2020-02-19	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205143-002	DICLOFENAC SODIUM AND MISOPROSTOL	75MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2020-02-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205143-001	DICLOFENAC SODIUM AND MISOPROSTOL	50MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2020-02-19	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A205143-002	DICLOFENAC SODIUM AND MISOPROSTOL	75MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2020-02-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205143-001	DICLOFENAC SODIUM AND MISOPROSTOL	50MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2020-02-19	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205143-002	DICLOFENAC SODIUM AND MISOPROSTOL	75MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2020-02-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A205143-001	DICLOFENAC SODIUM AND MISOPROSTOL	50MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2020-02-19	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A205143-002	DICLOFENAC SODIUM AND MISOPROSTOL	75MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2020-02-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A205143-001	DICLOFENAC SODIUM AND MISOPROSTOL	50MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2020-02-19	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A205143-002	DICLOFENAC SODIUM AND MISOPROSTOL	75MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2020-02-19	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A205143-001	DICLOFENAC SODIUM AND MISOPROSTOL	50MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2020-02-19	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A205143-002	DICLOFENAC SODIUM AND MISOPROSTOL	75MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2020-02-19	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 78 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	A205143-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A205143-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A205143-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205143-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A205143-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205143-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205143-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205143-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205143-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205143-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205143-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205143-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205143-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205143-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205143-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205143-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205143-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205143-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205143-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205143-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205143-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205143-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205143-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205143-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205143-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205143-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205143-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205143-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205143-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205143-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205143-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A205143-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205143-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205143-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A205143-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A205143-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A205143-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A205143-002	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A205143-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A205143-002	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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Diclofenac Sodium Misoprostol	DICLOFENAC SODIUM AND MISOPROSTOL	Bryant Ranch Prepack	6865a5cf-3263-44b5-96d9-7a7a4c6e1c05	2026-05-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205143 application number: ANDA205143
Diclofenac Sodium Misoprostol	DICLOFENAC SODIUM AND MISOPROSTOL	Bryant Ranch Prepack	de4c02a5-87e8-42f5-a9ff-f409ff9e6d62	2026-03-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205143 application number: ANDA205143
Diclofenac Sodium Misoprostol	DICLOFENAC SODIUM AND MISOPROSTOL	Bryant Ranch Prepack	6f9684f7-f39a-4f5e-9fd4-ed140fae206b	2026-03-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205143 application number: ANDA205143
Diclofenac Sodium Misoprostol	DICLOFENAC SODIUM AND MISOPROSTOL	Nivagen Pharmaceuticals, Inc.	2acf46ac-8ba8-444d-b421-19d5ad49644c	2025-12-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205143 application number: ANDA205143 ndc (product): 75834-264 ndc (product): 75834-265
Diclofenac Sodium Misoprostol	DICLOFENAC SODIUM AND MISOPROSTOL	Proficient Rx LP	33f7db0b-f049-4d2e-abf5-4db97222e175	2022-07-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205143 application number: ANDA205143 ndc (product): 71205-866 ndc (product): 71205-865

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 12 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
63126-341	Diclofenac Sodium and Misoprostol Delayed-Release	Diclofenac Sodium and Misoprostol	Yung Shin Pharmaceutical Industrual Co., Ltd.	ANDA	Current
63126-342	Diclofenac Sodium and Misoprostol Delayed-Release	Diclofenac Sodium and Misoprostol	Yung Shin Pharmaceutical Industrual Co., Ltd.	ANDA	Current
71205-865	Diclofenac Sodium Misoprostol	Diclofenac Sodium and Misoprostol	Proficient Rx LP	ANDA	Current
71205-865	Diclofenac Sodium Misoprostol	Diclofenac Sodium and Misoprostol	Proficient Rx LP	ANDA	Current
71205-865	Diclofenac Sodium Misoprostol	Diclofenac Sodium and Misoprostol	Proficient Rx LP	ANDA	Current
71205-866	Diclofenac Sodium Misoprostol	Diclofenac Sodium and Misoprostol	Proficient Rx LP	ANDA	Current
71205-866	Diclofenac Sodium Misoprostol	Diclofenac Sodium and Misoprostol	Proficient Rx LP	ANDA	Current
71205-866	Diclofenac Sodium Misoprostol	Diclofenac Sodium and Misoprostol	Proficient Rx LP	ANDA	Current
75834-264	Diclofenac Sodium Misoprostol	Diclofenac Sodium and Misoprostol	Nivagen Pharmaceuticals, Inc.	ANDA	Current
75834-264	Diclofenac Sodium Misoprostol	Diclofenac Sodium and Misoprostol	Nivagen Pharmaceuticals, Inc.	ANDA	Current
75834-265	Diclofenac Sodium Misoprostol	Diclofenac Sodium and Misoprostol	Nivagen Pharmaceuticals, Inc.	ANDA	Current
75834-265	Diclofenac Sodium Misoprostol	Diclofenac Sodium and Misoprostol	Nivagen Pharmaceuticals, Inc.	ANDA	Current