Application 019617

Type: NDA
Sponsor: PHARMACIA AND UPJOHN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PREPIDIL	DINOPROSTONE	GEL;ENDOCERVICAL	0.5MG/3GM	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N019617-001	PREPIDIL	DINOPROSTONE	0.5MG/3GM	GEL / ENDOCERVICAL		RLD, RS	1992-12-09

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 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N019617-001	PREPIDIL	0.5MG/3GM	GEL / ENDOCERVICAL	RLD, RS	1992-12-09	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N019617-001	PREPIDIL	0.5MG/3GM	GEL / ENDOCERVICAL	RLD, RS	1992-12-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019617-001	PREPIDIL	0.5MG/3GM	GEL / ENDOCERVICAL	RLD, RS	1992-12-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019617-001	PREPIDIL	0.5MG/3GM	GEL / ENDOCERVICAL	RLD, RS	1992-12-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019617-001	PREPIDIL	0.5MG/3GM	GEL / ENDOCERVICAL	RLD, RS	1992-12-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019617-001	PREPIDIL	0.5MG/3GM	GEL / ENDOCERVICAL	RLD, RS	1992-12-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019617-001	PREPIDIL	0.5MG/3GM	GEL / ENDOCERVICAL	RLD, RS	1992-12-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019617-001	PREPIDIL	0.5MG/3GM	GEL / ENDOCERVICAL	RLD, RS	1992-12-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019617-001	PREPIDIL	0.5MG/3GM	GEL / ENDOCERVICAL	RLD, RS	1992-12-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019617-001	PREPIDIL	0.5MG/3GM	GEL / ENDOCERVICAL	RLD, RS	1992-12-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N019617-001	PREPIDIL	0.5MG/3GM	GEL / ENDOCERVICAL	RLD, RS	1992-12-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019617-001	PREPIDIL	0.5MG/3GM	GEL / ENDOCERVICAL	RLD, RS	1992-12-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019617-001	PREPIDIL	0.5MG/3GM	GEL / ENDOCERVICAL	RLD, RS	1992-12-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019617-001	PREPIDIL	0.5MG/3GM	GEL / ENDOCERVICAL	RLD, RS	1992-12-09	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N019617-001	PREPIDIL	0.5MG/3GM	GEL / ENDOCERVICAL	RLD, RS	1992-12-09	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019617-001	PREPIDIL	0.5MG/3GM	GEL / ENDOCERVICAL	RLD, RS	1992-12-09	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N019617-001	PREPIDIL	0.5MG/3GM	GEL / ENDOCERVICAL	RLD, RS	1992-12-09	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N019617-001	PREPIDIL	0.5MG/3GM	GEL / ENDOCERVICAL	RLD, RS	1992-12-09	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N019617-001	PREPIDIL	0.5MG/3GM	GEL / ENDOCERVICAL	RLD, RS	1992-12-09	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N019617-001	PREPIDIL	0.5MG/3GM	GEL / ENDOCERVICAL	RLD, RS	1992-12-09	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N019617-001	PREPIDIL	0.5MG/3GM	GEL / ENDOCERVICAL	RLD, RS	1992-12-09	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N019617-001	PREPIDIL	0.5MG/3GM	GEL / ENDOCERVICAL	RLD, RS	1992-12-09	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N019617-001	PREPIDIL	0.5MG/3GM	GEL / ENDOCERVICAL	RLD, RS	1992-12-09	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N019617-001	PREPIDIL	0.5MG/3GM	GEL / ENDOCERVICAL	RLD, RS	1992-12-09	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N019617-001	PREPIDIL	0.5MG/3GM	GEL / ENDOCERVICAL	RLD, RS	1992-12-09	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N019617-001	PREPIDIL	0.5MG/3GM	GEL / ENDOCERVICAL	RLD, RS	1992-12-09	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N019617-001	PREPIDIL	0.5MG/3GM	GEL / ENDOCERVICAL	RLD, RS	1992-12-09	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N019617-001	PREPIDIL	0.5MG/3GM	GEL / ENDOCERVICAL	RLD, RS	1992-12-09	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N019617-001	PREPIDIL	0.5MG/3GM	GEL / ENDOCERVICAL	RLD, RS	1992-12-09	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N019617-001	PREPIDIL	0.5MG/3GM	GEL / ENDOCERVICAL	RLD, RS	1992-12-09	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N019617-001	PREPIDIL	0.5MG/3GM	GEL / ENDOCERVICAL	RLD, RS	1992-12-09	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N019617-001	PREPIDIL	0.5MG/3GM	GEL / ENDOCERVICAL	RLD, RS	1992-12-09	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N019617-001	PREPIDIL	0.5MG/3GM	GEL / ENDOCERVICAL	RLD, RS	1992-12-09	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N019617-001	PREPIDIL	0.5MG/3GM	GEL / ENDOCERVICAL	RLD, RS	1992-12-09	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N019617-001	PREPIDIL	0.5MG/3GM	GEL / ENDOCERVICAL	RLD, RS	1992-12-09	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N019617-001	PREPIDIL	0.5MG/3GM	GEL / ENDOCERVICAL	RLD, RS	1992-12-09	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N019617-001	PREPIDIL	0.5MG/3GM	GEL / ENDOCERVICAL	RLD, RS	1992-12-09	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N019617-001	PREPIDIL	0.5MG/3GM	GEL / ENDOCERVICAL	RLD, RS	1992-12-09	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N019617-001	PREPIDIL	0.5MG/3GM	GEL / ENDOCERVICAL	RLD, RS	1992-12-09	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N019617-001	PREPIDIL	0.5MG/3GM	GEL / ENDOCERVICAL	RLD, RS	1992-12-09	`e64feba35796…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Prepidil	DINOPROSTONE	Pharmacia & Upjohn Company LLC	ab03de5b-782c-4f81-a8dc-7ef9969dd0cf	2025-10-22	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019617 application number: NDA019617 ndc (product): 0009-3359

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0009-3359	Prepidil	dinoprostone	Pharmacia and Upjohn Company LLC	NDA	Current
0009-3359	Prepidil	dinoprostone	Pharmacia and Upjohn Company LLC	NDA	Current
0009-3359	Prepidil	dinoprostone	Pharmacia and Upjohn Company LLC	NDA	Current
0009-3359	Prepidil	dinoprostone	Pharmacia and Upjohn Company LLC	NDA	Current
0009-3359	Prepidil	dinoprostone	Pharmacia and Upjohn Company LLC	NDA	Current
0009-3359	Prepidil	dinoprostone	Pharmacia and Upjohn Company LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
48919	SUPPL	2017-07-06
48916	SUPPL	2017-07-06
1420	SUPPL	2010-02-22
11564	SUPPL	2010-02-16