Application 021258

Type: NDA
Sponsor: BAYER HLTHCARE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CLIMARA PRO	ESTRADIOL; LEVONORGESTREL	FILM, EXTENDED RELEASE;TRANSDERMAL	0.045MG/24HR;0.015MG/24HR	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
N021258-001	CLIMARA PRO	ESTRADIOL; LEVONORGESTREL	0.045MG/24HR;0.015MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL		RLD, RS	2003-11-21

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 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N021258-001	CLIMARA PRO	0.045MG/24HR;0.015MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2003-11-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021258-001	CLIMARA PRO	0.045MG/24HR;0.015MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2003-11-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021258-001	CLIMARA PRO	0.045MG/24HR;0.015MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2003-11-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021258-001	CLIMARA PRO	0.045MG/24HR;0.015MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2003-11-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021258-001	CLIMARA PRO	0.045MG/24HR;0.015MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2003-11-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021258-001	CLIMARA PRO	0.045MG/24HR;0.015MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2003-11-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021258-001	CLIMARA PRO	0.045MG/24HR;0.015MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2003-11-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021258-001	CLIMARA PRO	0.045MG/24HR;0.015MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2003-11-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021258-001	CLIMARA PRO	0.045MG/24HR;0.015MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2003-11-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021258-001	CLIMARA PRO	0.045MG/24HR;0.015MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2003-11-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021258-001	CLIMARA PRO	0.045MG/24HR;0.015MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2003-11-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021258-001	CLIMARA PRO	0.045MG/24HR;0.015MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2003-11-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021258-001	CLIMARA PRO	0.045MG/24HR;0.015MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2003-11-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021258-001	CLIMARA PRO	0.045MG/24HR;0.015MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2003-11-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021258-001	CLIMARA PRO	0.045MG/24HR;0.015MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2003-11-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021258-001	CLIMARA PRO	0.045MG/24HR;0.015MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2003-11-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021258-001	CLIMARA PRO	0.045MG/24HR;0.015MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2003-11-21	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021258-001	CLIMARA PRO	0.045MG/24HR;0.015MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2003-11-21	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021258-001	CLIMARA PRO	0.045MG/24HR;0.015MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2003-11-21	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021258-001	CLIMARA PRO	0.045MG/24HR;0.015MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2003-11-21	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021258-001	CLIMARA PRO	0.045MG/24HR;0.015MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2003-11-21	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021258-001	CLIMARA PRO	0.045MG/24HR;0.015MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2003-11-21	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021258-001	CLIMARA PRO	0.045MG/24HR;0.015MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2003-11-21	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021258-001	CLIMARA PRO	0.045MG/24HR;0.015MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2003-11-21	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021258-001	CLIMARA PRO	0.045MG/24HR;0.015MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2003-11-21	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021258-001	CLIMARA PRO	0.045MG/24HR;0.015MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2003-11-21	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021258-001	CLIMARA PRO	0.045MG/24HR;0.015MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2003-11-21	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021258-001	CLIMARA PRO	0.045MG/24HR;0.015MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2003-11-21	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021258-001	CLIMARA PRO	0.045MG/24HR;0.015MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2003-11-21	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021258-001	CLIMARA PRO	0.045MG/24HR;0.015MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2003-11-21	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021258-001	CLIMARA PRO	0.045MG/24HR;0.015MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2003-11-21	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021258-001	CLIMARA PRO	0.045MG/24HR;0.015MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2003-11-21	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021258-001	CLIMARA PRO	0.045MG/24HR;0.015MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2003-11-21	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021258-001	CLIMARA PRO	0.045MG/24HR;0.015MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2003-11-21	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021258-001	CLIMARA PRO	0.045MG/24HR;0.015MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2003-11-21	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021258-001	CLIMARA PRO	0.045MG/24HR;0.015MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2003-11-21	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021258-001	CLIMARA PRO	0.045MG/24HR;0.015MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2003-11-21	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021258-001	CLIMARA PRO	0.045MG/24HR;0.015MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2003-11-21	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021258-001	CLIMARA PRO	0.045MG/24HR;0.015MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2003-11-21	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021258-001	CLIMARA PRO	0.045MG/24HR;0.015MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2003-11-21	`cb3db0bc1861…`

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
Climara Pro	ESTRADIOL AND LEVONORGESTREL	Bayer HealthCare Pharmaceuticals Inc.	184d3092-7fc6-4375-816b-1ab06bb99cfd	2026-03-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021258 application number: NDA021258 ndc (product): 50419-491

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
50419-491	Climara Pro	Estradiol and Levonorgestrel	Bayer HealthCare Pharmaceuticals Inc.	NDA	Current
50419-491	Climara Pro	Estradiol and Levonorgestrel	Bayer HealthCare Pharmaceuticals Inc.	NDA	Current
50419-491	Climara Pro	Estradiol and Levonorgestrel	Bayer HealthCare Pharmaceuticals Inc.	NDA	Current
50419-491	Climara Pro	Estradiol and Levonorgestrel	Bayer HealthCare Pharmaceuticals Inc.	NDA	Current
50419-491	Climara Pro	Estradiol and Levonorgestrel	Bayer HealthCare Pharmaceuticals Inc.	NDA	Current
50419-491	Climara Pro	Estradiol and Levonorgestrel	Bayer HealthCare Pharmaceuticals Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
77559	SUPPL	2024-02-20
69326	SUPPL	2021-11-16
69315	SUPPL	2021-11-16
68951	SUPPL	2021-10-12
50264	SUPPL	2017-11-02
36489	SUPPL	2013-10-17
4808	SUPPL	2013-10-11
21553	ORIG	2006-06-07
36488	SUPPL	2005-06-24
4807	SUPPL	2005-06-24
36487	ORIG	2004-04-01
4806	ORIG	2003-11-28