Application 020946

Type: NDA
Sponsor: TEVA BRANDED PHARM

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PREVEN EMERGENCY CONTRACEPTIVE KIT	ETHINYL ESTRADIOL; LEVONORGESTREL	TABLET;ORAL	0.05MG;0.25MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
N020946-001	PREVEN EMERGENCY CONTRACEPTIVE KIT	ETHINYL ESTRADIOL; LEVONORGESTREL	0.05MG;0.25MG	TABLET / ORAL			1998-09-01

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 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2022-10-28 04:53 UTC	2022-10	N020946-001	PREVEN EMERGENCY CONTRACEPTIVE KIT	0.05MG;0.25MG	TABLET / ORAL	1998-09-01	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N020946-001	PREVEN EMERGENCY CONTRACEPTIVE KIT	0.05MG;0.25MG	TABLET / ORAL	1998-09-01	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N020946-001	PREVEN EMERGENCY CONTRACEPTIVE KIT	0.05MG;0.25MG	TABLET / ORAL	1998-09-01	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N020946-001	PREVEN EMERGENCY CONTRACEPTIVE KIT	0.05MG;0.25MG	TABLET / ORAL	1998-09-01	`a50c72e98297…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N020946-001	6156742	2020-12-05	U-374	`74a2ff9319b5…`
2020-12-22 03:56 UTC	2020-12	N020946-001	6156742	2020-12-05	U-374	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020946-001	6156742	2020-12-05	U-374	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020946-001	6156742	2020-12-05	U-374	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020946-001	6156742	2020-12-05	U-374	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020946-001	6156742	2020-12-05	U-374	`ea99ee380514…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

Document, Submission type, Date table
Document	Submission type	Date
41832	SUPPL	1999-06-07
41831	ORIG	1998-09-01
35702	ORIG	1998-09-01
3833	ORIG	1998-09-01