Application 021871

Type: NDA
Sponsor: TEVA BRANDED PHARM

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LOESTRIN 24 FE	ETHINYL ESTRADIOL; NORETHINDRONE ACETATE	TABLET;ORAL	0.02MG;1MG	Yes	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
N021871-001	LOESTRIN 24 FE	ETHINYL ESTRADIOL; NORETHINDRONE ACETATE	0.02MG;1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2006-02-17

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	RLD / RS	Approval date	Source SHA-256
2022-10-28 04:53 UTC	2022-10	N021871-001	LOESTRIN 24 FE	0.02MG;1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2006-02-17	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021871-001	LOESTRIN 24 FE	0.02MG;1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2006-02-17	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021871-001	LOESTRIN 24 FE	0.02MG;1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2006-02-17	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N021871-001	LOESTRIN 24 FE	0.02MG;1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2006-02-17	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N021871-001	AB	1	`74a2ff9319b5…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021871-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021871-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021871-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021871-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021871-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021871-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021871-001	AB	1	`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
73102	SUPPL	2023-01-06
73095	SUPPL	2023-01-04
70963	SUPPL	2022-05-04
70938	SUPPL	2022-05-03
68620	SUPPL	2021-09-14
68546	SUPPL	2021-09-07
49379	SUPPL	2017-08-15
49303	SUPPL	2017-08-09
45110	SUPPL	2016-08-23
45154	SUPPL	2016-08-22
42334	ORIG	2008-03-24
6347	ORIG	2006-03-01
16490	ORIG	2006-02-23