Application 020472

Type: NDA
Sponsor: PHARMACIA AND UPJOHN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ESTRING	ESTRADIOL	INSERT, EXTENDED RELEASE;VAGINAL	0.0075MG/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
N020472-001	ESTRING	ESTRADIOL	0.0075MG/24HR	INSERT, EXTENDED RELEASE / VAGINAL		RLD, RS	1996-04-26

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	N020472-001	ESTRING	0.0075MG/24HR	INSERT, EXTENDED RELEASE / VAGINAL	RLD, RS	1996-04-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020472-001	ESTRING	0.0075MG/24HR	INSERT, EXTENDED RELEASE / VAGINAL	RLD, RS	1996-04-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020472-001	ESTRING	0.0075MG/24HR	INSERT, EXTENDED RELEASE / VAGINAL	RLD, RS	1996-04-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020472-001	ESTRING	0.0075MG/24HR	INSERT, EXTENDED RELEASE / VAGINAL	RLD, RS	1996-04-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020472-001	ESTRING	0.0075MG/24HR	INSERT, EXTENDED RELEASE / VAGINAL	RLD, RS	1996-04-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020472-001	ESTRING	0.0075MG/24HR	INSERT, EXTENDED RELEASE / VAGINAL	RLD, RS	1996-04-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020472-001	ESTRING	0.0075MG/24HR	INSERT, EXTENDED RELEASE / VAGINAL	RLD, RS	1996-04-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020472-001	ESTRING	0.0075MG/24HR	INSERT, EXTENDED RELEASE / VAGINAL	RLD, RS	1996-04-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020472-001	ESTRING	0.0075MG/24HR	INSERT, EXTENDED RELEASE / VAGINAL	RLD, RS	1996-04-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020472-001	ESTRING	0.0075MG/24HR	INSERT, EXTENDED RELEASE / VAGINAL	RLD, RS	1996-04-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020472-001	ESTRING	0.0075MG/24HR	INSERT, EXTENDED RELEASE / VAGINAL	RLD, RS	1996-04-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020472-001	ESTRING	0.0075MG/24HR	INSERT, EXTENDED RELEASE / VAGINAL	RLD, RS	1996-04-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020472-001	ESTRING	0.0075MG/24HR	INSERT, EXTENDED RELEASE / VAGINAL	RLD, RS	1996-04-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020472-001	ESTRING	0.0075MG/24HR	INSERT, EXTENDED RELEASE / VAGINAL	RLD, RS	1996-04-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020472-001	ESTRING	0.0075MG/24HR	INSERT, EXTENDED RELEASE / VAGINAL	RLD, RS	1996-04-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020472-001	ESTRING	0.0075MG/24HR	INSERT, EXTENDED RELEASE / VAGINAL	RLD, RS	1996-04-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020472-001	ESTRING	0.0075MG/24HR	INSERT, EXTENDED RELEASE / VAGINAL	RLD, RS	1996-04-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020472-001	ESTRING	0.0075MG/24HR	INSERT, EXTENDED RELEASE / VAGINAL	RLD, RS	1996-04-26	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020472-001	ESTRING	0.0075MG/24HR	INSERT, EXTENDED RELEASE / VAGINAL	RLD, RS	1996-04-26	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020472-001	ESTRING	0.0075MG/24HR	INSERT, EXTENDED RELEASE / VAGINAL	RLD, RS	1996-04-26	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020472-001	ESTRING	0.0075MG/24HR	INSERT, EXTENDED RELEASE / VAGINAL	RLD, RS	1996-04-26	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020472-001	ESTRING	0.0075MG/24HR	INSERT, EXTENDED RELEASE / VAGINAL	RLD, RS	1996-04-26	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020472-001	ESTRING	0.0075MG/24HR	INSERT, EXTENDED RELEASE / VAGINAL	RLD, RS	1996-04-26	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020472-001	ESTRING	0.0075MG/24HR	INSERT, EXTENDED RELEASE / VAGINAL	RLD, RS	1996-04-26	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020472-001	ESTRING	0.0075MG/24HR	INSERT, EXTENDED RELEASE / VAGINAL	RLD, RS	1996-04-26	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020472-001	ESTRING	0.0075MG/24HR	INSERT, EXTENDED RELEASE / VAGINAL	RLD, RS	1996-04-26	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020472-001	ESTRING	0.0075MG/24HR	INSERT, EXTENDED RELEASE / VAGINAL	RLD, RS	1996-04-26	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020472-001	ESTRING	0.0075MG/24HR	INSERT, EXTENDED RELEASE / VAGINAL	RLD, RS	1996-04-26	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020472-001	ESTRING	0.0075MG/24HR	INSERT, EXTENDED RELEASE / VAGINAL	RLD, RS	1996-04-26	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020472-001	ESTRING	0.0075MG/24HR	INSERT, EXTENDED RELEASE / VAGINAL	RLD, RS	1996-04-26	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020472-001	ESTRING	0.0075MG/24HR	INSERT, EXTENDED RELEASE / VAGINAL	RLD, RS	1996-04-26	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020472-001	ESTRING	0.0075MG/24HR	INSERT, EXTENDED RELEASE / VAGINAL	RLD, RS	1996-04-26	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020472-001	ESTRING	0.0075MG/24HR	INSERT, EXTENDED RELEASE / VAGINAL	RLD, RS	1996-04-26	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020472-001	ESTRING	0.0075MG/24HR	INSERT, EXTENDED RELEASE / VAGINAL	RLD, RS	1996-04-26	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020472-001	ESTRING	0.0075MG/24HR	INSERT, EXTENDED RELEASE / VAGINAL	RLD, RS	1996-04-26	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020472-001	ESTRING	0.0075MG/24HR	INSERT, EXTENDED RELEASE / VAGINAL	RLD, RS	1996-04-26	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020472-001	ESTRING	0.0075MG/24HR	INSERT, EXTENDED RELEASE / VAGINAL	RLD, RS	1996-04-26	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020472-001	ESTRING	0.0075MG/24HR	INSERT, EXTENDED RELEASE / VAGINAL	RLD, RS	1996-04-26	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N020472-001	ESTRING	0.0075MG/24HR	INSERT, EXTENDED RELEASE / VAGINAL	RLD, RS	1996-04-26	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N020472-001	ESTRING	0.0075MG/24HR	INSERT, EXTENDED RELEASE / VAGINAL	RLD, RS	1996-04-26	`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
Estring	ESTRADIOL	Pfizer Laboratories Div Pfizer Inc	110b9865-5a07-4d45-b560-e89947f12600	2026-04-23	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020472 application number: NDA020472

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 7 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0013-2150	Estring	estradiol	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0013-2150	Estring	estradiol	Pharmacia and Upjohn Company LLC	NDA	Current
0013-2150	Estring	estradiol	Pharmacia and Upjohn Company LLC	NDA	Current
63539-021	Estring	estradiol	U.S. Pharmaceuticals	NDA	Current
63539-021	Estring	estradiol	U.S. Pharmaceuticals	NDA	Current
63539-021	Estring	estradiol	U.S. Pharmaceuticals	NDA	Current
63539-021	Estring	estradiol	U.S. Pharmaceuticals	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
85031	SUPPL	2026-02-12
85017	SUPPL	2026-02-12
77576	SUPPL	2024-02-20
77557	SUPPL	2024-02-16
77556	SUPPL	2024-02-16
74120	ORIG	2023-04-28
71728	SUPPL	2022-08-05
71650	SUPPL	2022-07-28
57108	ORIG	2019-01-03
50300	SUPPL	2017-11-06
50274	SUPPL	2017-11-02
34685	SUPPL	2015-12-10
12617	SUPPL	2015-12-10
25013	SUPPL	2015-09-30
2575	SUPPL	2015-09-30
2574	SUPPL	2014-08-14
34684	SUPPL	2014-08-13
41385	SUPPL	2009-01-12
20672	SUPPL	2009-01-12
20671	SUPPL	2009-01-12
34683	SUPPL	2008-08-29
25012	SUPPL	2008-08-27