Application 020870

Type: NDA
Sponsor: NOVEN PHARMS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	COMBIPATCH	ESTRADIOL; NORETHINDRONE ACETATE	FILM, EXTENDED RELEASE;TRANSDERMAL	0.05MG/24HR;0.14MG/24HR	Yes	No
002	COMBIPATCH	ESTRADIOL; NORETHINDRONE ACETATE	FILM, EXTENDED RELEASE;TRANSDERMAL	0.05MG/24HR;0.25MG/24HR	Yes	Yes

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

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
N020870-001	COMBIPATCH	ESTRADIOL; NORETHINDRONE ACETATE	0.05MG/24HR;0.14MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL		RLD, RS	1998-08-07
N020870-002	COMBIPATCH	ESTRADIOL; NORETHINDRONE ACETATE	0.05MG/24HR;0.25MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL		RLD, RS	1998-08-07

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 · 84 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	N020870-001	COMBIPATCH	0.05MG/24HR;0.14MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	1998-08-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020870-002	COMBIPATCH	0.05MG/24HR;0.25MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	1998-08-07	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020870-001	COMBIPATCH	0.05MG/24HR;0.14MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1998-08-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020870-002	COMBIPATCH	0.05MG/24HR;0.25MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	1998-08-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020870-001	COMBIPATCH	0.05MG/24HR;0.14MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1998-08-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020870-002	COMBIPATCH	0.05MG/24HR;0.25MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	1998-08-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020870-001	COMBIPATCH	0.05MG/24HR;0.14MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1998-08-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020870-002	COMBIPATCH	0.05MG/24HR;0.25MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	1998-08-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020870-001	COMBIPATCH	0.05MG/24HR;0.14MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1998-08-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020870-002	COMBIPATCH	0.05MG/24HR;0.25MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	1998-08-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020870-001	COMBIPATCH	0.05MG/24HR;0.14MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1998-08-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020870-002	COMBIPATCH	0.05MG/24HR;0.25MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	1998-08-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020870-001	COMBIPATCH	0.05MG/24HR;0.14MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1998-08-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020870-002	COMBIPATCH	0.05MG/24HR;0.25MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	1998-08-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020870-001	COMBIPATCH	0.05MG/24HR;0.14MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1998-08-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020870-002	COMBIPATCH	0.05MG/24HR;0.25MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	1998-08-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020870-001	COMBIPATCH	0.05MG/24HR;0.14MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1998-08-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020870-002	COMBIPATCH	0.05MG/24HR;0.25MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	1998-08-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020870-001	COMBIPATCH	0.05MG/24HR;0.14MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1998-08-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020870-002	COMBIPATCH	0.05MG/24HR;0.25MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	1998-08-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020870-001	COMBIPATCH	0.05MG/24HR;0.14MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1998-08-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020870-002	COMBIPATCH	0.05MG/24HR;0.25MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	1998-08-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020870-001	COMBIPATCH	0.05MG/24HR;0.14MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1998-08-07	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020870-002	COMBIPATCH	0.05MG/24HR;0.25MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	1998-08-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020870-001	COMBIPATCH	0.05MG/24HR;0.14MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1998-08-07	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020870-002	COMBIPATCH	0.05MG/24HR;0.25MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	1998-08-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020870-001	COMBIPATCH	0.05MG/24HR;0.14MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1998-08-07	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020870-002	COMBIPATCH	0.05MG/24HR;0.25MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	1998-08-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020870-001	COMBIPATCH	0.05MG/24HR;0.14MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1998-08-07	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N020870-002	COMBIPATCH	0.05MG/24HR;0.25MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	1998-08-07	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020870-001	COMBIPATCH	0.05MG/24HR;0.14MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1998-08-07	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020870-002	COMBIPATCH	0.05MG/24HR;0.25MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	1998-08-07	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020870-001	COMBIPATCH	0.05MG/24HR;0.14MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1998-08-07	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N020870-002	COMBIPATCH	0.05MG/24HR;0.25MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	1998-08-07	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020870-001	COMBIPATCH	0.05MG/24HR;0.14MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1998-08-07	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020870-002	COMBIPATCH	0.05MG/24HR;0.25MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	1998-08-07	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020870-001	COMBIPATCH	0.05MG/24HR;0.14MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1998-08-07	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020870-002	COMBIPATCH	0.05MG/24HR;0.25MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	1998-08-07	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020870-001	COMBIPATCH	0.05MG/24HR;0.14MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1998-08-07	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N020870-002	COMBIPATCH	0.05MG/24HR;0.25MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	1998-08-07	`bb7c543d1eb4…`

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
CombiPatch (estradiol/norethindrone acetate transdermal system)	ESTRADIOL/NORETHINDRONE ACETATE TRANSDERMAL SYSTEM	Noven Therapeutics, LLC	83198ef1-11c4-11e4-9191-0800200c9a66	2024-02-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 020870 application number: NDA020870 ndc (product): 68968-0525 ndc (product): 68968-0514

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 12 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
68968-0514	CombiPatch (estradiol/norethindrone acetate transdermal system)	estradiol/norethindrone acetate transdermal system	Noven Therapeutics, LLC	NDA	Current
68968-0514	CombiPatch (estradiol/norethindrone acetate transdermal system)	estradiol/norethindrone acetate transdermal system	Noven Therapeutics, LLC	NDA	Current
68968-0514	CombiPatch (estradiol/norethindrone acetate transdermal system)	estradiol/norethindrone acetate transdermal system	Noven Therapeutics, LLC	NDA	Current
68968-0514	CombiPatch (estradiol/norethindrone acetate transdermal system)	estradiol/norethindrone acetate transdermal system	Noven Therapeutics, LLC	NDA	Current
68968-0514	CombiPatch (estradiol/norethindrone acetate transdermal system)	estradiol/norethindrone acetate transdermal system	Noven Therapeutics, LLC	NDA	Current
68968-0514	CombiPatch (estradiol/norethindrone acetate transdermal system)	estradiol/norethindrone acetate transdermal system	Noven Therapeutics, LLC	NDA	Current
68968-0525	CombiPatch (estradiol/norethindrone acetate transdermal system)	estradiol/norethindrone acetate transdermal system	Noven Therapeutics, LLC	NDA	Current
68968-0525	CombiPatch (estradiol/norethindrone acetate transdermal system)	estradiol/norethindrone acetate transdermal system	Noven Therapeutics, LLC	NDA	Current
68968-0525	CombiPatch (estradiol/norethindrone acetate transdermal system)	estradiol/norethindrone acetate transdermal system	Noven Therapeutics, LLC	NDA	Current
68968-0525	CombiPatch (estradiol/norethindrone acetate transdermal system)	estradiol/norethindrone acetate transdermal system	Noven Therapeutics, LLC	NDA	Current
68968-0525	CombiPatch (estradiol/norethindrone acetate transdermal system)	estradiol/norethindrone acetate transdermal system	Noven Therapeutics, LLC	NDA	Current
68968-0525	CombiPatch (estradiol/norethindrone acetate transdermal system)	estradiol/norethindrone acetate transdermal system	Noven Therapeutics, LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
77535	SUPPL	2024-02-16
77519	SUPPL	2024-02-16
50266	SUPPL	2017-11-02
26095	SUPPL	2015-05-11
35548	SUPPL	2015-05-08
35547	SUPPL	2013-09-24
26094	SUPPL	2013-09-20
35546	SUPPL	2005-11-18
26093	SUPPL	2005-11-18
26092	SUPPL	2005-01-18
13653	SUPPL	2005-01-18
35545	SUPPL	2004-06-23
3624	SUPPL	2004-06-23
41774	ORIG	1998-08-07
26091	ORIG	1998-08-07
13652	ORIG	1998-08-07