Application 204355

Type: ANDA
Sponsor: MICRO LABS

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
A204355-001	DICLOFENAC SODIUM AND MISOPROSTOL	DICLOFENAC SODIUM; MISOPROSTOL	50MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB		2021-07-15
A204355-002	DICLOFENAC SODIUM AND MISOPROSTOL	DICLOFENAC SODIUM; MISOPROSTOL	75MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB		2021-07-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A204355-001	AB
A204355-002	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 · 66 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	A204355-001	DICLOFENAC SODIUM AND MISOPROSTOL	50MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2021-07-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204355-002	DICLOFENAC SODIUM AND MISOPROSTOL	75MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2021-07-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204355-001	DICLOFENAC SODIUM AND MISOPROSTOL	50MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2021-07-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204355-002	DICLOFENAC SODIUM AND MISOPROSTOL	75MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2021-07-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204355-001	DICLOFENAC SODIUM AND MISOPROSTOL	50MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2021-07-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204355-002	DICLOFENAC SODIUM AND MISOPROSTOL	75MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2021-07-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204355-001	DICLOFENAC SODIUM AND MISOPROSTOL	50MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2021-07-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204355-002	DICLOFENAC SODIUM AND MISOPROSTOL	75MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2021-07-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204355-001	DICLOFENAC SODIUM AND MISOPROSTOL	50MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2021-07-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204355-002	DICLOFENAC SODIUM AND MISOPROSTOL	75MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2021-07-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204355-001	DICLOFENAC SODIUM AND MISOPROSTOL	50MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2021-07-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204355-002	DICLOFENAC SODIUM AND MISOPROSTOL	75MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2021-07-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204355-001	DICLOFENAC SODIUM AND MISOPROSTOL	50MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2021-07-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204355-002	DICLOFENAC SODIUM AND MISOPROSTOL	75MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2021-07-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204355-001	DICLOFENAC SODIUM AND MISOPROSTOL	50MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2021-07-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204355-002	DICLOFENAC SODIUM AND MISOPROSTOL	75MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2021-07-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204355-001	DICLOFENAC SODIUM AND MISOPROSTOL	50MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2021-07-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204355-002	DICLOFENAC SODIUM AND MISOPROSTOL	75MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2021-07-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204355-001	DICLOFENAC SODIUM AND MISOPROSTOL	50MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2021-07-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204355-002	DICLOFENAC SODIUM AND MISOPROSTOL	75MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2021-07-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204355-001	DICLOFENAC SODIUM AND MISOPROSTOL	50MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2021-07-15	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204355-002	DICLOFENAC SODIUM AND MISOPROSTOL	75MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2021-07-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204355-001	DICLOFENAC SODIUM AND MISOPROSTOL	50MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2021-07-15	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204355-002	DICLOFENAC SODIUM AND MISOPROSTOL	75MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2021-07-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204355-001	DICLOFENAC SODIUM AND MISOPROSTOL	50MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2021-07-15	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204355-002	DICLOFENAC SODIUM AND MISOPROSTOL	75MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2021-07-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204355-001	DICLOFENAC SODIUM AND MISOPROSTOL	50MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2021-07-15	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A204355-002	DICLOFENAC SODIUM AND MISOPROSTOL	75MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2021-07-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204355-001	DICLOFENAC SODIUM AND MISOPROSTOL	50MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2021-07-15	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204355-002	DICLOFENAC SODIUM AND MISOPROSTOL	75MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2021-07-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204355-001	DICLOFENAC SODIUM AND MISOPROSTOL	50MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2021-07-15	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A204355-002	DICLOFENAC SODIUM AND MISOPROSTOL	75MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2021-07-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204355-001	DICLOFENAC SODIUM AND MISOPROSTOL	50MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2021-07-15	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A204355-002	DICLOFENAC SODIUM AND MISOPROSTOL	75MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2021-07-15	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A204355-001	DICLOFENAC SODIUM AND MISOPROSTOL	50MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2021-07-15	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A204355-002	DICLOFENAC SODIUM AND MISOPROSTOL	75MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2021-07-15	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204355-001	DICLOFENAC SODIUM AND MISOPROSTOL	50MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2021-07-15	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A204355-002	DICLOFENAC SODIUM AND MISOPROSTOL	75MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2021-07-15	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204355-001	DICLOFENAC SODIUM AND MISOPROSTOL	50MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2021-07-15	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204355-002	DICLOFENAC SODIUM AND MISOPROSTOL	75MG;0.2MG	TABLET, DELAYED RELEASE / ORAL	AB	2021-07-15	`6a51e52b5d6a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 66 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	A204355-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204355-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204355-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204355-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204355-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204355-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204355-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204355-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204355-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204355-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204355-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204355-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204355-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204355-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204355-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204355-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204355-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204355-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204355-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204355-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204355-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204355-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204355-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204355-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204355-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204355-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204355-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A204355-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204355-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204355-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204355-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A204355-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204355-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A204355-002	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A204355-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A204355-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204355-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A204355-002	AB	1	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204355-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204355-002	AB	1	`6a51e52b5d6a…`

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Diclofenac Sodium/Misoprostol DICLOFENAC-SODIUM-MISOPROSTOL	DICLOFENAC SODIUM/MISOPROSTOL	Sportpharm LLC	0d6509a1-7af8-473b-8951-c19439274379	2026-03-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204355 application number: ANDA204355
Diclofenac Sodium/Misoprostol DICLOFENAC-SODIUM-MISOPROSTOL	DICLOFENAC SODIUM/MISOPROSTOL	Micro Labs Limited	c61df58d-d6bb-4d3e-9ef8-60caa7d4e762	2025-07-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204355 application number: ANDA204355 ndc (product): 42571-133 ndc (product): 42571-134
Diclofenac Sodium/Misoprostol DICLOFENAC-SODIUM-MISOPROSTOL	DICLOFENAC SODIUM/MISOPROSTOL	Bryant Ranch Prepack	7225385c-501c-4e90-8948-8617d583108c	2025-06-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204355 application number: ANDA204355
DICLOENAC SODIUM and MISOPROSTOL DR	DICLOENAC SODIUM AND MISOPROSTOL	Advanced Rx Pharmacy of Tennessee, LLC	f4d8c198-63e1-3109-e053-2995a90acad9	2024-02-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204355 application number: ANDA204355

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 9 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
42571-133	Diclofenac Sodium/Misoprostol	Diclofenac Sodium/Misoprostol	Micro Labs Limited	ANDA	Current
42571-133	Diclofenac Sodium/Misoprostol	Diclofenac Sodium/Misoprostol	Micro Labs Limited	ANDA	Current
42571-133	Diclofenac Sodium/Misoprostol	Diclofenac Sodium/Misoprostol	Micro Labs Limited	ANDA	Current
42571-133	Diclofenac Sodium/Misoprostol	Diclofenac Sodium/Misoprostol	Micro Labs Limited	ANDA	Current
42571-134	Diclofenac Sodium/Misoprostol	Diclofenac Sodium/Misoprostol	Micro Labs Limited	ANDA	Current
42571-134	Diclofenac Sodium/Misoprostol	Diclofenac Sodium/Misoprostol	Micro Labs Limited	ANDA	Current
42571-134	Diclofenac Sodium/Misoprostol	Diclofenac Sodium/Misoprostol	Micro Labs Limited	ANDA	Current
42571-134	Diclofenac Sodium/Misoprostol	Diclofenac Sodium/Misoprostol	Micro Labs Limited	ANDA	Current
68788-8214	Diclofenac Sodium/Misoprostol	Diclofenac Sodium/Misoprostol	Preferred Pharmaceuticals Inc.	ANDA	Current