Application 019268

Type: NDA
Sponsor: GD SEARLE LLC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CYTOTEC	MISOPROSTOL	TABLET;ORAL	0.2MG	Yes	Yes
003	CYTOTEC	MISOPROSTOL	TABLET;ORAL	0.1MG	Yes	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
N019268-001	CYTOTEC	MISOPROSTOL	0.2MG	TABLET / ORAL	AB	RLD, RS	1988-12-27
N019268-003	CYTOTEC	MISOPROSTOL	0.1MG	TABLET / ORAL	AB	RLD	1990-09-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N019268-001	AB
N019268-003	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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N019268-001	CYTOTEC	0.2MG	TABLET / ORAL	AB	RLD, RS	1988-12-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019268-003	CYTOTEC	0.1MG	TABLET / ORAL	AB	RLD	1990-09-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019268-001	CYTOTEC	0.2MG	TABLET / ORAL	AB	RLD, RS	1988-12-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019268-003	CYTOTEC	0.1MG	TABLET / ORAL	AB	RLD	1990-09-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019268-001	CYTOTEC	0.2MG	TABLET / ORAL	AB	RLD, RS	1988-12-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019268-003	CYTOTEC	0.1MG	TABLET / ORAL	AB	RLD	1990-09-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019268-001	CYTOTEC	0.2MG	TABLET / ORAL	AB	RLD, RS	1988-12-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019268-003	CYTOTEC	0.1MG	TABLET / ORAL	AB	RLD	1990-09-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019268-001	CYTOTEC	0.2MG	TABLET / ORAL	AB	RLD, RS	1988-12-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019268-003	CYTOTEC	0.1MG	TABLET / ORAL	AB	RLD	1990-09-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019268-001	CYTOTEC	0.2MG	TABLET / ORAL	AB	RLD, RS	1988-12-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019268-003	CYTOTEC	0.1MG	TABLET / ORAL	AB	RLD	1990-09-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019268-001	CYTOTEC	0.2MG	TABLET / ORAL	AB	RLD, RS	1988-12-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019268-003	CYTOTEC	0.1MG	TABLET / ORAL	AB	RLD	1990-09-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019268-001	CYTOTEC	0.2MG	TABLET / ORAL	AB	RLD, RS	1988-12-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019268-003	CYTOTEC	0.1MG	TABLET / ORAL	AB	RLD	1990-09-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019268-001	CYTOTEC	0.2MG	TABLET / ORAL	AB	RLD, RS	1988-12-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019268-003	CYTOTEC	0.1MG	TABLET / ORAL	AB	RLD	1990-09-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N019268-001	CYTOTEC	0.2MG	TABLET / ORAL	AB	RLD, RS	1988-12-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N019268-003	CYTOTEC	0.1MG	TABLET / ORAL	AB	RLD	1990-09-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019268-001	CYTOTEC	0.2MG	TABLET / ORAL	AB	RLD, RS	1988-12-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019268-003	CYTOTEC	0.1MG	TABLET / ORAL	AB	RLD	1990-09-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019268-001	CYTOTEC	0.2MG	TABLET / ORAL	AB	RLD, RS	1988-12-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019268-003	CYTOTEC	0.1MG	TABLET / ORAL	AB	RLD	1990-09-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019268-001	CYTOTEC	0.2MG	TABLET / ORAL	AB	RLD, RS	1988-12-27	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019268-003	CYTOTEC	0.1MG	TABLET / ORAL	AB	RLD	1990-09-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N019268-001	CYTOTEC	0.2MG	TABLET / ORAL	AB	RLD, RS	1988-12-27	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N019268-003	CYTOTEC	0.1MG	TABLET / ORAL	AB	RLD	1990-09-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019268-001	CYTOTEC	0.2MG	TABLET / ORAL	AB	RLD, RS	1988-12-27	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019268-003	CYTOTEC	0.1MG	TABLET / ORAL	AB	RLD	1990-09-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N019268-001	CYTOTEC	0.2MG	TABLET / ORAL	AB	RLD, RS	1988-12-27	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N019268-003	CYTOTEC	0.1MG	TABLET / ORAL	AB	RLD	1990-09-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N019268-001	CYTOTEC	0.2MG	TABLET / ORAL		RLD, RS	1988-12-27	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N019268-003	CYTOTEC	0.1MG	TABLET / ORAL		RLD	1990-09-21	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N019268-001	CYTOTEC	0.2MG	TABLET / ORAL	AB	RLD, RS	1988-12-27	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N019268-003	CYTOTEC	0.1MG	TABLET / ORAL	AB	RLD	1990-09-21	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N019268-001	CYTOTEC	0.2MG	TABLET / ORAL		RLD, RS	1988-12-27	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N019268-003	CYTOTEC	0.1MG	TABLET / ORAL		RLD	1990-09-21	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N019268-001	CYTOTEC	0.2MG	TABLET / ORAL		RLD, RS	1988-12-27	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N019268-003	CYTOTEC	0.1MG	TABLET / ORAL		RLD	1990-09-21	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 76 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	N019268-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019268-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019268-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019268-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019268-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019268-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019268-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019268-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019268-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019268-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019268-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019268-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019268-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019268-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019268-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019268-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019268-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019268-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N019268-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N019268-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019268-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019268-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019268-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019268-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019268-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019268-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N019268-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N019268-003	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019268-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019268-003	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N019268-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N019268-003	AB	1	`5d02ea3f76ae…`
2019-12-13 00:20 UTC	2019-12	N019268-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N019268-003	AB	1	`74a2ff9319b5…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N019268-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N019268-003	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N019268-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N019268-003	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N019268-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N019268-003	AB	1	`8869cabd3fbd…`

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
misoprostol	MISOPROSTOL	Bryant Ranch Prepack	c842c35f-6a64-4ecc-95a1-41b6d056047e	2026-06-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 019268 application number: NDA019268
Cytotec	MISOPROSTOL	Pfizer Laboratories Div Pfizer Inc	4ab12da7-5731-4e06-bf1c-bc3f2e711f12	2026-06-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 019268 application number: NDA019268 ndc (product): 0025-1451 ndc (product): 0025-1461
misoprostol	MISOPROSTOL	Mylan Pharmaceuticals Inc.	c4fe14fb-0a43-4c31-9cd6-29eb0d156705	2026-05-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 019268 application number: NDA019268 ndc (product): 59762-5007 ndc (product): 59762-5008
misoprostol	MISOPROSTOL	Redpharm Drug	2fd197c6-05db-5011-e063-6294a90a585d	2025-12-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 019268 application number: NDA019268

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 34 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0025-1451	Cytotec	misoprostol	G.D. Searle LLC Division of Pfizer Inc	NDA	Current
0025-1451	Cytotec	misoprostol	G.D. Searle LLC Division of Pfizer Inc	NDA	Current
0025-1451	Cytotec	misoprostol	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0025-1451	Cytotec	misoprostol	G.D. Searle LLC Division of Pfizer Inc	NDA	Current
0025-1451	Cytotec	misoprostol	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0025-1451	Cytotec	misoprostol	G.D. Searle LLC Division of Pfizer Inc	NDA	Current
0025-1461	Cytotec	misoprostol	G.D. Searle LLC Division of Pfizer Inc	NDA	Current
0025-1461	Cytotec	misoprostol	G.D. Searle LLC Division of Pfizer Inc	NDA	Current
0025-1461	Cytotec	misoprostol	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0025-1461	Cytotec	misoprostol	G.D. Searle LLC Division of Pfizer Inc	NDA	Current
0025-1461	Cytotec	misoprostol	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0025-1461	Cytotec	misoprostol	G.D. Searle LLC Division of Pfizer Inc	NDA	Current
12634-502	misoprostol	MISOPROSTOL	Apotheca Inc.	NDA AUTHORIZED GENERIC	Current
12634-933	CYTOTEC	MISOPROSTOL	Apotheca, Inc	NDA	Current
43393-020	misoprostol	MISOPROSTOL	GenBioPro, Inc.	NDA AUTHORIZED GENERIC	Current
43393-020	misoprostol	MISOPROSTOL	GenBioPro, Inc.	NDA AUTHORIZED GENERIC	Current
52959-692	misoprostol	misoprostol	H.J. Harkins Company, Inc.	NDA	Current
55289-248	Cytotec	misoprostol	PD-Rx Pharmaceuticals, In	NDA	Current
55289-248	Cytotec	misoprostol	PD-Rx Pharmaceuticals, Inc.	NDA	Current
55289-248	Cytotec	misoprostol	PD-Rx Pharmaceuticals, Inc.	NDA	Current
55289-248	Cytotec	misoprostol	PD-Rx Pharmaceuticals, Inc.	NDA	Current
55289-248	Cytotec	misoprostol	PD-Rx Pharmaceuticals, Inc.	NDA	Current
55289-248	Cytotec	misoprostol	PD-Rx Pharmaceuticals, Inc.	NDA	Current
59762-5007	misoprostol	MISOPROSTOL	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-5008	misoprostol	MISOPROSTOL	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
66336-608	misoprostol	MISOPROSTOL	Dispensing Solutions, Inc.	NDA AUTHORIZED GENERIC	Current
72789-111	misoprostol	MISOPROSTOL	PD-Rx Pharmaceuticals, Inc.	NDA AUTHORIZED GENERIC	Current
72789-111	misoprostol	MISOPROSTOL	PD-Rx Pharmaceuticals, Inc.	NDA AUTHORIZED GENERIC	Current
72789-111	misoprostol	MISOPROSTOL	PD-Rx Pharmaceuticals, Inc.	NDA AUTHORIZED GENERIC	Current
72789-128	misoprostol	MISOPROSTOL	PD-Rx Pharmaceuticals, Inc.	NDA AUTHORIZED GENERIC	Current
72789-128	misoprostol	MISOPROSTOL	PD-Rx Pharmaceuticals, Inc.	NDA AUTHORIZED GENERIC	Current
72789-128	misoprostol	MISOPROSTOL	PD-Rx Pharmaceuticals, Inc.	NDA AUTHORIZED GENERIC	Current
72789-128	misoprostol	MISOPROSTOL	PD-Rx Pharmaceuticals, Inc.	NDA AUTHORIZED GENERIC	Current
72789-128	misoprostol	MISOPROSTOL	PD-Rx Pharmaceuticals, Inc.	NDA AUTHORIZED GENERIC	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
52779	SUPPL	2018-03-01
52774	SUPPL	2018-03-01
46223	SUPPL	2016-12-19
46222	SUPPL	2016-12-19
11465	SUPPL	2012-11-26
17344	SUPPL	2012-11-21
40882	ORIG	2011-12-16
1267	SUPPL	2009-11-12
33713	SUPPL	2009-10-06
44030	ORIG	2005-07-29
17343	SUPPL	2003-08-14
17342	SUPPL	2003-08-14
17341	SUPPL	2002-04-17
11464	SUPPL	2002-04-17