Application 021813

Type: NDA
Sponsor: MYLAN SPECIALITY LP

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ELESTRIN	ESTRADIOL	GEL, METERED;TRANSDERMAL	0.06% (0.87GM/ACTIVATION)	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
N021813-001	ELESTRIN	ESTRADIOL	0.06% (0.87GM/ACTIVATION)	GEL, METERED / TRANSDERMAL		RLD, RS	2006-12-15

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 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N021813-001	ELESTRIN	0.06% (0.87GM/ACTIVATION)	GEL, METERED / TRANSDERMAL	RLD, RS	2006-12-15	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021813-001	ELESTRIN	0.06% (0.87GM/ACTIVATION)	GEL, METERED / TRANSDERMAL	RLD, RS	2006-12-15	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021813-001	ELESTRIN	0.06% (0.87GM/ACTIVATION)	GEL, METERED / TRANSDERMAL	RLD, RS	2006-12-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021813-001	ELESTRIN	0.06% (0.87GM/ACTIVATION)	GEL, METERED / TRANSDERMAL	RLD, RS	2006-12-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021813-001	ELESTRIN	0.06% (0.87GM/ACTIVATION)	GEL, METERED / TRANSDERMAL	RLD, RS	2006-12-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021813-001	ELESTRIN	0.06% (0.87GM/ACTIVATION)	GEL, METERED / TRANSDERMAL	RLD, RS	2006-12-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021813-001	ELESTRIN	0.06% (0.87GM/ACTIVATION)	GEL, METERED / TRANSDERMAL	RLD, RS	2006-12-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021813-001	ELESTRIN	0.06% (0.87GM/ACTIVATION)	GEL, METERED / TRANSDERMAL	RLD, RS	2006-12-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021813-001	ELESTRIN	0.06% (0.87GM/ACTIVATION)	GEL, METERED / TRANSDERMAL	RLD, RS	2006-12-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021813-001	ELESTRIN	0.06% (0.87GM/ACTIVATION)	GEL, METERED / TRANSDERMAL	RLD, RS	2006-12-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021813-001	ELESTRIN	0.06% (0.87GM/ACTIVATION)	GEL, METERED / TRANSDERMAL	RLD, RS	2006-12-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021813-001	ELESTRIN	0.06% (0.87GM/ACTIVATION)	GEL, METERED / TRANSDERMAL	RLD, RS	2006-12-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021813-001	ELESTRIN	0.06% (0.87GM/ACTIVATION)	GEL, METERED / TRANSDERMAL	RLD, RS	2006-12-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021813-001	ELESTRIN	0.06% (0.87GM/ACTIVATION)	GEL, METERED / TRANSDERMAL	RLD, RS	2006-12-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021813-001	ELESTRIN	0.06% (0.87GM/ACTIVATION)	GEL, METERED / TRANSDERMAL	RLD, RS	2006-12-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021813-001	ELESTRIN	0.06% (0.87GM/ACTIVATION)	GEL, METERED / TRANSDERMAL	RLD, RS	2006-12-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021813-001	ELESTRIN	0.06% (0.87GM/ACTIVATION)	GEL, METERED / TRANSDERMAL	RLD, RS	2006-12-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021813-001	ELESTRIN	0.06% (0.87GM/ACTIVATION)	GEL, METERED / TRANSDERMAL	RLD, RS	2006-12-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021813-001	ELESTRIN	0.06% (0.87GM/ACTIVATION)	GEL, METERED / TRANSDERMAL	RLD, RS	2006-12-15	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021813-001	ELESTRIN	0.06% (0.87GM/ACTIVATION)	GEL, METERED / TRANSDERMAL	RLD, RS	2006-12-15	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021813-001	ELESTRIN	0.06% (0.87GM/ACTIVATION)	GEL, METERED / TRANSDERMAL	RLD, RS	2006-12-15	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021813-001	ELESTRIN	0.06% (0.87GM/ACTIVATION)	GEL, METERED / TRANSDERMAL	RLD, RS	2006-12-15	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021813-001	ELESTRIN	0.06% (0.87GM/ACTIVATION)	GEL, METERED / TRANSDERMAL	RLD, RS	2006-12-15	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021813-001	ELESTRIN	0.06% (0.87GM/ACTIVATION)	GEL, METERED / TRANSDERMAL	RLD, RS	2006-12-15	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021813-001	ELESTRIN	0.06% (0.87GM/ACTIVATION)	GEL, METERED / TRANSDERMAL	RLD, RS	2006-12-15	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021813-001	ELESTRIN	0.06% (0.87GM/ACTIVATION)	GEL, METERED / TRANSDERMAL	RLD, RS	2006-12-15	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021813-001	ELESTRIN	0.06% (0.87GM/ACTIVATION)	GEL, METERED / TRANSDERMAL	RLD, RS	2006-12-15	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021813-001	ELESTRIN	0.06% (0.87GM/ACTIVATION)	GEL, METERED / TRANSDERMAL	RLD, RS	2006-12-15	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021813-001	ELESTRIN	0.06% (0.87GM/ACTIVATION)	GEL, METERED / TRANSDERMAL	RLD, RS	2006-12-15	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021813-001	ELESTRIN	0.06% (0.87GM/ACTIVATION)	GEL, METERED / TRANSDERMAL	RLD, RS	2006-12-15	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021813-001	ELESTRIN	0.06% (0.87GM/ACTIVATION)	GEL, METERED / TRANSDERMAL	RLD, RS	2006-12-15	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021813-001	ELESTRIN	0.06% (0.87GM/ACTIVATION)	GEL, METERED / TRANSDERMAL	RLD, RS	2006-12-15	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021813-001	ELESTRIN	0.06% (0.87GM/ACTIVATION)	GEL, METERED / TRANSDERMAL	RLD, RS	2006-12-15	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021813-001	ELESTRIN	0.06% (0.87GM/ACTIVATION)	GEL, METERED / TRANSDERMAL	RLD, RS	2006-12-15	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021813-001	ELESTRIN	0.06% (0.87GM/ACTIVATION)	GEL, METERED / TRANSDERMAL	RLD, RS	2006-12-15	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021813-001	ELESTRIN	0.06% (0.87GM/ACTIVATION)	GEL, METERED / TRANSDERMAL	RLD, RS	2006-12-15	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021813-001	ELESTRIN	0.06% (0.87GM/ACTIVATION)	GEL, METERED / TRANSDERMAL	RLD, RS	2006-12-15	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021813-001	ELESTRIN	0.06% (0.87GM/ACTIVATION)	GEL, METERED / TRANSDERMAL	RLD, RS	2006-12-15	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021813-001	ELESTRIN	0.06% (0.87GM/ACTIVATION)	GEL, METERED / TRANSDERMAL	RLD, RS	2006-12-15	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021813-001	ELESTRIN	0.06% (0.87GM/ACTIVATION)	GEL, METERED / TRANSDERMAL	RLD, RS	2006-12-15	`f41ea6bd6efb…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021813-001	7198801	2022-06-25	Drug product	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021813-001	7198801	2022-06-25	Drug product	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021813-001	7198801	2022-06-25	Drug product	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021813-001	7470433	2021-08-03	Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021813-001	7198801	2022-06-25	Drug product	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021813-001	7198801	2022-06-25	Drug product	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021813-001	7470433	2021-08-03	Drug product	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021813-001	7198801	2022-06-25	Drug product	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021813-001	7470433	2021-08-03	Drug product	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021813-001	7198801	2022-06-25	Drug product	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021813-001	7470433	2021-08-03	Drug product	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021813-001	7198801	2022-06-25	Drug product	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021813-001	7470433	2021-08-03	Drug product	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021813-001	7198801	2022-06-25	Drug product	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021813-001	7470433	2021-08-03	Drug product	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021813-001	7198801	2022-06-25	Drug product	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021813-001	7470433	2021-08-03	Drug product	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021813-001	7198801	2022-06-25	Drug product	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021813-001	7470433	2021-08-03	Drug product	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021813-001	7198801	2022-06-25	Drug product	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021813-001	7470433	2021-08-03	Drug product	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021813-001	7198801	2022-06-25	Drug product	`ea99ee380514…`
2023-01-26 05:58 UTC	2023-01	N021813-001	7198801	2022-06-25	Drug product	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021813-001	7198801	2022-06-25	Drug product	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021813-001	7198801	2022-06-25	Drug product	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021813-001	7198801	2022-06-25	Drug product	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021813-001	7198801	2022-06-25	Drug product	`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
ELESTRIN	ESTRADIOL	Viatris Specialty LLC	eff2dea1-f117-11e3-ac10-0800200c9a66	2023-12-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021813 application number: NDA021813 ndc (product): 0037-4801

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 9 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0037-4801	ELESTRIN	ESTRADIOL	Meda Pharmaceuticals	NDA	Current
0037-4801	ELESTRIN	ESTRADIOL	Meda Pharmaceuticals	NDA	Current
0037-4801	ELESTRIN	ESTRADIOL	Meda Pharmaceuticals	NDA	Current
0037-4801	ELESTRIN	ESTRADIOL	Meda Pharmaceuticals	NDA	Current
0037-4801	ELESTRIN	ESTRADIOL	Meda Pharmaceuticals	NDA	Current
0037-4802	ELESTRIN	ESTRADIOL	Meda Pharmaceuticals	NDA	Current
0037-4802	ELESTRIN	ESTRADIOL	Meda Pharmaceuticals	NDA	Current
0037-4802	ELESTRIN	ESTRADIOL	Meda Pharmaceuticals	NDA	Current
0037-4802	ELESTRIN	ESTRADIOL	Meda Pharmaceuticals	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
77537	SUPPL	2024-02-16
77524	SUPPL	2024-02-16
65109	SUPPL	2020-10-30
65108	SUPPL	2020-10-30
65068	SUPPL	2020-10-29
65067	SUPPL	2020-10-29
50270	SUPPL	2017-11-02
16412	SUPPL	2014-03-04
6238	SUPPL	2012-02-29
37689	SUPPL	2012-02-28
42319	ORIG	2009-06-09
24217	ORIG	2009-06-09
6237	SUPPL	2008-02-29
6236	ORIG	2006-12-28
16411	ORIG	2006-12-26