Application 210201

Type: ANDA
Sponsor: ZYDUS PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	MISOPROSTOL	MISOPROSTOL	TABLET;ORAL	0.1MG	No	No
002	MISOPROSTOL	MISOPROSTOL	TABLET;ORAL	0.2MG	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
A210201-001	MISOPROSTOL	MISOPROSTOL	0.1MG	TABLET / ORAL	AB		2019-07-02
A210201-002	MISOPROSTOL	MISOPROSTOL	0.2MG	TABLET / ORAL	AB		2019-07-02

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A210201-001	AB
A210201-002	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	A210201-001	MISOPROSTOL	0.1MG	TABLET / ORAL	AB	2019-07-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210201-002	MISOPROSTOL	0.2MG	TABLET / ORAL	AB	2019-07-02	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210201-001	MISOPROSTOL	0.1MG	TABLET / ORAL	AB	2019-07-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210201-002	MISOPROSTOL	0.2MG	TABLET / ORAL	AB	2019-07-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210201-001	MISOPROSTOL	0.1MG	TABLET / ORAL	AB	2019-07-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210201-002	MISOPROSTOL	0.2MG	TABLET / ORAL	AB	2019-07-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210201-001	MISOPROSTOL	0.1MG	TABLET / ORAL	AB	2019-07-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210201-002	MISOPROSTOL	0.2MG	TABLET / ORAL	AB	2019-07-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210201-001	MISOPROSTOL	0.1MG	TABLET / ORAL	AB	2019-07-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210201-002	MISOPROSTOL	0.2MG	TABLET / ORAL	AB	2019-07-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210201-001	MISOPROSTOL	0.1MG	TABLET / ORAL	AB	2019-07-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210201-002	MISOPROSTOL	0.2MG	TABLET / ORAL	AB	2019-07-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210201-001	MISOPROSTOL	0.1MG	TABLET / ORAL	AB	2019-07-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210201-002	MISOPROSTOL	0.2MG	TABLET / ORAL	AB	2019-07-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210201-001	MISOPROSTOL	0.1MG	TABLET / ORAL	AB	2019-07-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210201-002	MISOPROSTOL	0.2MG	TABLET / ORAL	AB	2019-07-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210201-001	MISOPROSTOL	0.1MG	TABLET / ORAL		2019-07-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210201-002	MISOPROSTOL	0.2MG	TABLET / ORAL		2019-07-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210201-001	MISOPROSTOL	0.1MG	TABLET / ORAL	AB	2019-07-02	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210201-002	MISOPROSTOL	0.2MG	TABLET / ORAL	AB	2019-07-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210201-001	MISOPROSTOL	0.1MG	TABLET / ORAL		2019-07-02	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210201-002	MISOPROSTOL	0.2MG	TABLET / ORAL		2019-07-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210201-001	MISOPROSTOL	0.1MG	TABLET / ORAL		2019-07-02	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210201-002	MISOPROSTOL	0.2MG	TABLET / ORAL		2019-07-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210201-001	MISOPROSTOL	0.1MG	TABLET / ORAL		2019-07-02	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210201-002	MISOPROSTOL	0.2MG	TABLET / ORAL		2019-07-02	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210201-001	MISOPROSTOL	0.1MG	TABLET / ORAL		2019-07-02	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210201-002	MISOPROSTOL	0.2MG	TABLET / ORAL		2019-07-02	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210201-001	MISOPROSTOL	0.1MG	TABLET / ORAL		2019-07-02	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A210201-002	MISOPROSTOL	0.2MG	TABLET / ORAL		2019-07-02	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210201-001	MISOPROSTOL	0.1MG	TABLET / ORAL		2019-07-02	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210201-002	MISOPROSTOL	0.2MG	TABLET / ORAL		2019-07-02	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210201-001	MISOPROSTOL	0.1MG	TABLET / ORAL		2019-07-02	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A210201-002	MISOPROSTOL	0.2MG	TABLET / ORAL		2019-07-02	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210201-001	MISOPROSTOL	0.1MG	TABLET / ORAL		2019-07-02	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A210201-002	MISOPROSTOL	0.2MG	TABLET / ORAL		2019-07-02	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A210201-001	MISOPROSTOL	0.1MG	TABLET / ORAL	AB	2019-07-02	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A210201-002	MISOPROSTOL	0.2MG	TABLET / ORAL	AB	2019-07-02	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A210201-001	MISOPROSTOL	0.1MG	TABLET / ORAL		2019-07-02	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A210201-002	MISOPROSTOL	0.2MG	TABLET / ORAL		2019-07-02	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A210201-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210201-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210201-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210201-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210201-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210201-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210201-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210201-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210201-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210201-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210201-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210201-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210201-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210201-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210201-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210201-002	AB	1	`2680178bc6a6…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210201-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210201-002	AB	1	`d8e5a09893c0…`
2019-12-13 00:20 UTC	2019-12	A210201-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A210201-002	AB	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A210201-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A210201-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A210201-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A210201-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A210201-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A210201-002	AB	1	`ea99ee380514…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A210201-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A210201-002	AB	1	`a50c72e98297…`

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Misoprostol	MISOPROSTOL	GenBioPro, Inc.	21e20753-4a67-ce4e-e063-6394a90aa598	2026-06-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210201 application number: ANDA210201
Misoprostol	MISOPROSTOL	AvPAK	2396e9c0-3742-69cf-e063-6394a90adb13	2026-01-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210201 application number: ANDA210201
Misoprostol	MISOPROSTOL	GenBioPro, Inc.	28a4138c-f302-5109-e063-6394a90a94fa	2024-12-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210201 application number: ANDA210201

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
70710-1006	Misoprostol	Misoprostol	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70710-1007	Misoprostol	Misoprostol	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70771-1496	Misoprostol	Misoprostol	Cadila Healthcare Limited	ANDA	Current
70771-1497	Misoprostol	Misoprostol	Cadila Healthcare Limited	ANDA	Current