Application 216872

Type: ANDA
Sponsor: MICRO LABS

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
A216872-001	MISOPROSTOL	MISOPROSTOL	0.1MG	TABLET / ORAL	AB		2022-10-17
A216872-002	MISOPROSTOL	MISOPROSTOL	0.2MG	TABLET / ORAL	AB		2022-10-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A216872-001	AB
A216872-002	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 · 52 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	A216872-001	MISOPROSTOL	0.1MG	TABLET / ORAL	AB	2022-10-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A216872-002	MISOPROSTOL	0.2MG	TABLET / ORAL	AB	2022-10-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A216872-001	MISOPROSTOL	0.1MG	TABLET / ORAL	AB	2022-10-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216872-002	MISOPROSTOL	0.2MG	TABLET / ORAL	AB	2022-10-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216872-001	MISOPROSTOL	0.1MG	TABLET / ORAL	AB	2022-10-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216872-002	MISOPROSTOL	0.2MG	TABLET / ORAL	AB	2022-10-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A216872-001	MISOPROSTOL	0.1MG	TABLET / ORAL	AB	2022-10-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A216872-002	MISOPROSTOL	0.2MG	TABLET / ORAL	AB	2022-10-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216872-001	MISOPROSTOL	0.1MG	TABLET / ORAL	AB	2022-10-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216872-002	MISOPROSTOL	0.2MG	TABLET / ORAL	AB	2022-10-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216872-001	MISOPROSTOL	0.1MG	TABLET / ORAL	AB	2022-10-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216872-002	MISOPROSTOL	0.2MG	TABLET / ORAL	AB	2022-10-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216872-001	MISOPROSTOL	0.1MG	TABLET / ORAL	AB	2022-10-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216872-002	MISOPROSTOL	0.2MG	TABLET / ORAL	AB	2022-10-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216872-001	MISOPROSTOL	0.1MG	TABLET / ORAL	AB	2022-10-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216872-002	MISOPROSTOL	0.2MG	TABLET / ORAL	AB	2022-10-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216872-001	MISOPROSTOL	0.1MG	TABLET / ORAL	AB	2022-10-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216872-002	MISOPROSTOL	0.2MG	TABLET / ORAL	AB	2022-10-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216872-001	MISOPROSTOL	0.1MG	TABLET / ORAL	AB	2022-10-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216872-002	MISOPROSTOL	0.2MG	TABLET / ORAL	AB	2022-10-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A216872-001	MISOPROSTOL	0.1MG	TABLET / ORAL	AB	2022-10-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A216872-002	MISOPROSTOL	0.2MG	TABLET / ORAL	AB	2022-10-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216872-001	MISOPROSTOL	0.1MG	TABLET / ORAL	AB	2022-10-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216872-002	MISOPROSTOL	0.2MG	TABLET / ORAL	AB	2022-10-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216872-001	MISOPROSTOL	0.1MG	TABLET / ORAL	AB	2022-10-17	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216872-002	MISOPROSTOL	0.2MG	TABLET / ORAL	AB	2022-10-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216872-001	MISOPROSTOL	0.1MG	TABLET / ORAL	AB	2022-10-17	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216872-002	MISOPROSTOL	0.2MG	TABLET / ORAL	AB	2022-10-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A216872-001	MISOPROSTOL	0.1MG	TABLET / ORAL	AB	2022-10-17	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A216872-002	MISOPROSTOL	0.2MG	TABLET / ORAL	AB	2022-10-17	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A216872-001	MISOPROSTOL	0.1MG	TABLET / ORAL	AB	2022-10-17	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A216872-002	MISOPROSTOL	0.2MG	TABLET / ORAL	AB	2022-10-17	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A216872-001	MISOPROSTOL	0.1MG	TABLET / ORAL	AB	2022-10-17	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A216872-002	MISOPROSTOL	0.2MG	TABLET / ORAL	AB	2022-10-17	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A216872-001	MISOPROSTOL	0.1MG	TABLET / ORAL	AB	2022-10-17	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A216872-002	MISOPROSTOL	0.2MG	TABLET / ORAL	AB	2022-10-17	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A216872-001	MISOPROSTOL	0.1MG	TABLET / ORAL	AB	2022-10-17	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A216872-002	MISOPROSTOL	0.2MG	TABLET / ORAL	AB	2022-10-17	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A216872-001	MISOPROSTOL	0.1MG	TABLET / ORAL	AB	2022-10-17	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A216872-002	MISOPROSTOL	0.2MG	TABLET / ORAL	AB	2022-10-17	`9b2671bbb829…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 52 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A216872-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A216872-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A216872-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216872-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216872-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216872-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A216872-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A216872-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216872-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216872-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216872-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216872-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216872-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216872-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216872-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216872-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216872-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216872-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216872-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216872-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A216872-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A216872-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216872-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216872-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216872-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216872-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216872-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216872-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A216872-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A216872-002	AB	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A216872-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A216872-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A216872-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A216872-002	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A216872-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A216872-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A216872-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A216872-002	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A216872-001	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A216872-002	AB	1	`9b2671bbb829…`

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 · 19 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
misoprostol	MISOPROSTOL	Bryant Ranch Prepack	c842c35f-6a64-4ecc-95a1-41b6d056047e	2026-06-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: misoprostol generic name: MISOPROSTOL
Misoprostol	MISOPROSTOL	American Health Packaging	9462d969-d3e5-4e7f-b556-bd647ab28c42	2026-06-24	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Misoprostol generic name: MISOPROSTOL
Misoprostol	MISOPROSTOL	GenBioPro, Inc.	21e20753-4a67-ce4e-e063-6394a90aa598	2026-06-06	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Misoprostol generic name: MISOPROSTOL
Cytotec	MISOPROSTOL	Pfizer Laboratories Div Pfizer Inc	4ab12da7-5731-4e06-bf1c-bc3f2e711f12	2026-06-04	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MISOPROSTOL
misoprostol	MISOPROSTOL	Mylan Pharmaceuticals Inc.	c4fe14fb-0a43-4c31-9cd6-29eb0d156705	2026-05-23	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: misoprostol generic name: MISOPROSTOL
Misoprostol	MISOPROSTOL	Bryant Ranch Prepack	c4668066-3d67-487d-9071-f1e504f66499	2026-05-11	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Misoprostol generic name: MISOPROSTOL
Misoprostol	MISOPROSTOL	PD-Rx Pharmaceuticals, Inc.	51b0bac5-19e3-4547-ba1f-01494fda7687	2026-02-25	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Misoprostol generic name: MISOPROSTOL
Misoprostol	MISOPROSTOL	AvPAK	2396e9c0-3742-69cf-e063-6394a90adb13	2026-01-08	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Misoprostol generic name: MISOPROSTOL
misoprostol	MISOPROSTOL	Redpharm Drug	2fd197c6-05db-5011-e063-6294a90a585d	2025-12-27	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: misoprostol generic name: MISOPROSTOL
Misoprostol	MISOPROSTOL	Cardinal Health 107, LLC	52a82e45-afc5-47d0-a77f-a225609e2f6b	2025-11-12	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Misoprostol generic name: MISOPROSTOL
Misoprostol	MISOPROSTOL	ANI Pharmaceuticals, Inc.	21386aa1-dc51-41c9-8872-dec4c71ebb46	2025-10-23	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Misoprostol generic name: MISOPROSTOL
Misoprostol	MISOPROSTOL	NuCare Pharmaceuticals, Inc.	2b5d0fcb-cc9c-5bb0-e063-6294a90ab1c8	2025-01-14	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Misoprostol generic name: MISOPROSTOL
Misoprostol	MISOPROSTOL	GenBioPro, Inc.	28a4138c-f302-5109-e063-6394a90a94fa	2024-12-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Misoprostol generic name: MISOPROSTOL
Misoprostol	MISOPROSTOL	NuCare Pharmaceuticals,Inc.	8642b8e4-d1bb-f12a-e053-2a91aa0a14bf	2024-06-14	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Misoprostol generic name: MISOPROSTOL
Misoprostol	MISOPROSTOL	Proficient Rx LP	85410e16-d164-4666-9539-778e2b4dd138	2023-11-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Misoprostol generic name: MISOPROSTOL
Misoprostol	MISOPROSTOL	GenBioPro, Inc.	2f4d6f06-529c-4b54-908a-0db4c18aff67	2023-01-06	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Misoprostol generic name: MISOPROSTOL
Misoprostol	MISOPROSTOL	PharmPak, Inc.	b07b3dfc-1cb5-484c-be11-8d14c89c794f	2022-10-08	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Misoprostol generic name: MISOPROSTOL
Misoprostol	MISOPROSTOL	Lupin Pharmaceuticals,Inc.	14f73ae3-7d8d-4d10-b668-8bd5adf8032c	2020-12-21	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Misoprostol generic name: MISOPROSTOL
Misoprostol	MISOPROSTOL	Novel Laboratories, Inc.	a46d05a2-5014-40ff-8f1b-9eca1b0aff3a	2020-12-21	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Misoprostol generic name: MISOPROSTOL

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
42571-253	MISOPROSTOL	Misoprostol	Micro Labs Limited	ANDA	Current
42571-254	MISOPROSTOL	Misoprostol	Micro Labs Limited	ANDA	Current