Application 076095

Type: ANDA
Sponsor: ANI PHARMS INC

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 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
A076095-001	MISOPROSTOL	MISOPROSTOL	0.1MG	TABLET / ORAL	AB		2002-07-10
A076095-002	MISOPROSTOL	MISOPROSTOL	0.2MG	TABLET / ORAL	AB		2002-07-10

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A076095-001	AB
A076095-002	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	A076095-001	MISOPROSTOL	0.1MG	TABLET / ORAL	AB	2002-07-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076095-002	MISOPROSTOL	0.2MG	TABLET / ORAL	AB	2002-07-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076095-001	MISOPROSTOL	0.1MG	TABLET / ORAL	AB	2002-07-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076095-002	MISOPROSTOL	0.2MG	TABLET / ORAL	AB	2002-07-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076095-001	MISOPROSTOL	0.1MG	TABLET / ORAL	AB	2002-07-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076095-002	MISOPROSTOL	0.2MG	TABLET / ORAL	AB	2002-07-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076095-001	MISOPROSTOL	0.1MG	TABLET / ORAL	AB	2002-07-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076095-002	MISOPROSTOL	0.2MG	TABLET / ORAL	AB	2002-07-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076095-001	MISOPROSTOL	0.1MG	TABLET / ORAL	AB	2002-07-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076095-002	MISOPROSTOL	0.2MG	TABLET / ORAL	AB	2002-07-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076095-001	MISOPROSTOL	0.1MG	TABLET / ORAL	AB	2002-07-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076095-002	MISOPROSTOL	0.2MG	TABLET / ORAL	AB	2002-07-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076095-001	MISOPROSTOL	0.1MG	TABLET / ORAL	AB	2002-07-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076095-002	MISOPROSTOL	0.2MG	TABLET / ORAL	AB	2002-07-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076095-001	MISOPROSTOL	0.1MG	TABLET / ORAL	AB	2002-07-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076095-002	MISOPROSTOL	0.2MG	TABLET / ORAL	AB	2002-07-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076095-001	MISOPROSTOL	0.1MG	TABLET / ORAL	AB	2002-07-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076095-002	MISOPROSTOL	0.2MG	TABLET / ORAL	AB	2002-07-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076095-001	MISOPROSTOL	0.1MG	TABLET / ORAL	AB	2002-07-10	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076095-002	MISOPROSTOL	0.2MG	TABLET / ORAL	AB	2002-07-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076095-001	MISOPROSTOL	0.1MG	TABLET / ORAL	AB	2002-07-10	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076095-002	MISOPROSTOL	0.2MG	TABLET / ORAL	AB	2002-07-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076095-001	MISOPROSTOL	0.1MG	TABLET / ORAL	AB	2002-07-10	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076095-002	MISOPROSTOL	0.2MG	TABLET / ORAL	AB	2002-07-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076095-001	MISOPROSTOL	0.1MG	TABLET / ORAL	AB	2002-07-10	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076095-002	MISOPROSTOL	0.2MG	TABLET / ORAL	AB	2002-07-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076095-001	MISOPROSTOL	0.1MG	TABLET / ORAL	AB	2002-07-10	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A076095-002	MISOPROSTOL	0.2MG	TABLET / ORAL	AB	2002-07-10	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076095-001	MISOPROSTOL	0.1MG	TABLET / ORAL	AB	2002-07-10	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076095-002	MISOPROSTOL	0.2MG	TABLET / ORAL	AB	2002-07-10	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076095-001	MISOPROSTOL	0.1MG	TABLET / ORAL	AB	2002-07-10	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A076095-002	MISOPROSTOL	0.2MG	TABLET / ORAL	AB	2002-07-10	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076095-001	MISOPROSTOL	0.1MG	TABLET / ORAL		2002-07-10	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A076095-002	MISOPROSTOL	0.2MG	TABLET / ORAL		2002-07-10	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076095-001	MISOPROSTOL	0.1MG	TABLET / ORAL	AB	2002-07-10	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076095-002	MISOPROSTOL	0.2MG	TABLET / ORAL	AB	2002-07-10	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076095-001	MISOPROSTOL	0.1MG	TABLET / ORAL		2002-07-10	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A076095-002	MISOPROSTOL	0.2MG	TABLET / ORAL		2002-07-10	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076095-001	MISOPROSTOL	0.1MG	TABLET / ORAL		2002-07-10	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A076095-002	MISOPROSTOL	0.2MG	TABLET / ORAL		2002-07-10	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 68 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	A076095-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076095-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076095-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076095-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076095-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076095-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076095-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076095-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076095-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076095-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076095-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076095-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076095-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076095-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076095-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076095-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076095-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076095-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076095-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076095-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076095-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076095-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076095-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076095-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076095-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076095-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076095-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A076095-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076095-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076095-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076095-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A076095-002	AB	1	`5d02ea3f76ae…`
2019-12-13 00:20 UTC	2019-12	A076095-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076095-002	AB	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A076095-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A076095-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076095-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A076095-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076095-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A076095-002	AB	1	`ea99ee380514…`

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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Misoprostol	MISOPROSTOL	American Health Packaging	9462d969-d3e5-4e7f-b556-bd647ab28c42	2026-06-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076095 application number: ANDA076095
Misoprostol	MISOPROSTOL	Bryant Ranch Prepack	c4668066-3d67-487d-9071-f1e504f66499	2026-05-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076095 application number: ANDA076095
Misoprostol	MISOPROSTOL	PD-Rx Pharmaceuticals, Inc.	51b0bac5-19e3-4547-ba1f-01494fda7687	2026-02-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076095 application number: ANDA076095
Misoprostol	MISOPROSTOL	Cardinal Health 107, LLC	52a82e45-afc5-47d0-a77f-a225609e2f6b	2025-11-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076095 application number: ANDA076095
Misoprostol	MISOPROSTOL	ANI Pharmaceuticals, Inc.	21386aa1-dc51-41c9-8872-dec4c71ebb46	2025-10-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076095 application number: ANDA076095 ndc (product): 70954-443 ndc (product): 70954-444
Misoprostol	MISOPROSTOL	NuCare Pharmaceuticals, Inc.	2b5d0fcb-cc9c-5bb0-e063-6294a90ab1c8	2025-01-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076095 application number: ANDA076095
Misoprostol	MISOPROSTOL	Proficient Rx LP	85410e16-d164-4666-9539-778e2b4dd138	2023-11-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076095 application number: ANDA076095
Misoprostol	MISOPROSTOL	GenBioPro, Inc.	2f4d6f06-529c-4b54-908a-0db4c18aff67	2023-01-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076095 application number: ANDA076095 ndc (product): 43393-023

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
10135-745	Misoprostol	Misoprostol	Marlex Pharmaceuticals, Inc.	ANDA	Current
10135-746	Misoprostol	Misoprostol	Marlex Pharmaceuticals, Inc.	ANDA	Current
43393-023	Misoprostol	Misoprostol	GenBioPro, Inc.	ANDA	Current
68071-2904	Misoprostol	Misoprostol	NuCare Pharmaceuticals,Inc.	ANDA	Current
70954-443	Misoprostol	Misoprostol	Novitium Pharma LLC	ANDA	Current
70954-443	Misoprostol	Misoprostol	Novitium Pharma LLC	ANDA	Current
70954-444	Misoprostol	Misoprostol	Novitium Pharma LLC	ANDA	Current
70954-444	Misoprostol	Misoprostol	Novitium Pharma LLC	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
23801	ORIG	2005-07-29
22535	ORIG	2005-07-22
31075	ORIG	2002-07-10