Application 004782

Type: NDA
Sponsor: WYETH PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PREMARIN	ESTROGENS, CONJUGATED	TABLET;ORAL	1.25MG	Yes	Yes
002	PREMARIN	ESTROGENS, CONJUGATED	TABLET;ORAL	2.5MG	No	No
003	PREMARIN	ESTROGENS, CONJUGATED	TABLET;ORAL	0.3MG	Yes	No
004	PREMARIN	ESTROGENS, CONJUGATED	TABLET;ORAL	0.625MG	Yes	Yes
005	PREMARIN	ESTROGENS, CONJUGATED	TABLET;ORAL	0.9MG	Yes	Yes
006	PREMARIN	ESTROGENS, CONJUGATED	TABLET;ORAL	0.45MG	Yes	No

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

Orange Book products#

Current product rows page 1 of 1 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N004782-001	PREMARIN	ESTROGENS, CONJUGATED	1.25MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982
N004782-002	PREMARIN	ESTROGENS, CONJUGATED	2.5MG	TABLET / ORAL		Approved before 1982
N004782-003	PREMARIN	ESTROGENS, CONJUGATED	0.3MG	TABLET / ORAL	AB	RLD, Approved before 1982
N004782-004	PREMARIN	ESTROGENS, CONJUGATED	0.625MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982
N004782-005	PREMARIN	ESTROGENS, CONJUGATED	0.9MG	TABLET / ORAL	AB	RLD, RS	1984-01-26
N004782-006	PREMARIN	ESTROGENS, CONJUGATED	0.45MG	TABLET / ORAL	AB	RLD	2003-07-16

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 5 matching rows.

Application-product, TE code table
Application-product	TE code
N004782-001	AB
N004782-003	AB
N004782-004	AB
N004782-005	AB
N004782-006	AB

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 7 · 246 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N004782-001	PREMARIN	1.25MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N004782-002	PREMARIN	2.5MG	TABLET / ORAL		Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N004782-003	PREMARIN	0.3MG	TABLET / ORAL	AB	RLD, Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N004782-004	PREMARIN	0.625MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N004782-005	PREMARIN	0.9MG	TABLET / ORAL	AB	RLD, RS	1984-01-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N004782-006	PREMARIN	0.45MG	TABLET / ORAL	AB	RLD	2003-07-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N004782-001	PREMARIN	1.25MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N004782-002	PREMARIN	2.5MG	TABLET / ORAL		Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N004782-003	PREMARIN	0.3MG	TABLET / ORAL	AB	RLD, Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N004782-004	PREMARIN	0.625MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N004782-005	PREMARIN	0.9MG	TABLET / ORAL	AB	RLD, RS	1984-01-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N004782-006	PREMARIN	0.45MG	TABLET / ORAL	AB	RLD	2003-07-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N004782-001	PREMARIN	1.25MG	TABLET / ORAL		RLD, RS, Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N004782-002	PREMARIN	2.5MG	TABLET / ORAL		Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N004782-003	PREMARIN	0.3MG	TABLET / ORAL		RLD, Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N004782-004	PREMARIN	0.625MG	TABLET / ORAL		RLD, RS, Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N004782-005	PREMARIN	0.9MG	TABLET / ORAL		RLD, RS	1984-01-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N004782-006	PREMARIN	0.45MG	TABLET / ORAL		RLD	2003-07-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N004782-001	PREMARIN	1.25MG	TABLET / ORAL		RLD, RS, Approved before 1982		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N004782-002	PREMARIN	2.5MG	TABLET / ORAL		Approved before 1982		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N004782-003	PREMARIN	0.3MG	TABLET / ORAL		RLD, Approved before 1982		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N004782-004	PREMARIN	0.625MG	TABLET / ORAL		RLD, RS, Approved before 1982		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N004782-005	PREMARIN	0.9MG	TABLET / ORAL		RLD, RS	1984-01-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N004782-006	PREMARIN	0.45MG	TABLET / ORAL		RLD	2003-07-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N004782-001	PREMARIN	1.25MG	TABLET / ORAL		RLD, RS, Approved before 1982		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N004782-002	PREMARIN	2.5MG	TABLET / ORAL		Approved before 1982		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N004782-003	PREMARIN	0.3MG	TABLET / ORAL		RLD, Approved before 1982		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N004782-004	PREMARIN	0.625MG	TABLET / ORAL		RLD, RS, Approved before 1982		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N004782-005	PREMARIN	0.9MG	TABLET / ORAL		RLD, RS	1984-01-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N004782-006	PREMARIN	0.45MG	TABLET / ORAL		RLD	2003-07-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N004782-001	PREMARIN	1.25MG	TABLET / ORAL		RLD, RS, Approved before 1982		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N004782-002	PREMARIN	2.5MG	TABLET / ORAL		Approved before 1982		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N004782-003	PREMARIN	0.3MG	TABLET / ORAL		RLD, Approved before 1982		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N004782-004	PREMARIN	0.625MG	TABLET / ORAL		RLD, RS, Approved before 1982		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N004782-005	PREMARIN	0.9MG	TABLET / ORAL		RLD, RS	1984-01-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N004782-006	PREMARIN	0.45MG	TABLET / ORAL		RLD	2003-07-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N004782-001	PREMARIN	1.25MG	TABLET / ORAL		RLD, RS, Approved before 1982		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N004782-002	PREMARIN	2.5MG	TABLET / ORAL		Approved before 1982		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N004782-003	PREMARIN	0.3MG	TABLET / ORAL		RLD, Approved before 1982		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N004782-004	PREMARIN	0.625MG	TABLET / ORAL		RLD, RS, Approved before 1982		`2680178bc6a6…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N004782-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N004782-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N004782-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N004782-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N004782-006	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N004782-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N004782-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N004782-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N004782-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N004782-006	AB	1	`31067a03dcf5…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N004782-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N004782-003	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N004782-004	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N004782-005	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N004782-006	AB	1	`a50c72e98297…`

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Premarin	ESTROGENS, CONJUGATED	Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.	258e1602-a3cf-4ccc-ca80-73dbbfb812ff	2026-06-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 004782 application number: NDA004782 ndc (product): 0046-1101 ndc (product): 0046-1102 ndc (product): 0046-1103 ndc (product): 0046-1100 ndc (product): 0046-1104
Conjugated Estrogens	ESTROGENS, CONJUGATED	Prasco Laboratories	ce793f9e-0c20-43e6-9dc0-064e5c82e243	2026-02-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 004782 application number: NDA004782
Premarin	ESTROGENS, CONJUGATED	A-S Medication Solutions	a3b86b85-8923-42ae-aa31-a66a6e090327	2025-04-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 004782 application number: NDA004782 ndc (product): 50090-0167
PREMARIN	ESTROGENS, CONJUGATED	A-S Medication Solutions	2b4dbb7c-4e6d-47c9-b940-fef91f1f4a05	2024-02-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 004782 application number: NDA004782 ndc (product): 50090-1853

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 33 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0046-1100	Premarin	estrogens, conjugated	Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.	NDA	Current
0046-1100	Premarin	estrogens, conjugated	Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.	NDA	Current
0046-1100	Premarin	estrogens, conjugated	Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.	NDA	Current
0046-1100	Premarin	estrogens, conjugated	Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.	NDA	Current
0046-1100	Premarin	estrogens, conjugated	Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.	NDA	Current
0046-1101	Premarin	estrogens, conjugated	Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.	NDA	Current
0046-1101	Premarin	estrogens, conjugated	Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.	NDA	Current
0046-1101	Premarin	estrogens, conjugated	Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.	NDA	Current
0046-1101	Premarin	estrogens, conjugated	Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.	NDA	Current
0046-1101	Premarin	estrogens, conjugated	Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.	NDA	Current
0046-1102	Premarin	estrogens, conjugated	Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.	NDA	Current
0046-1102	Premarin	estrogens, conjugated	Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.	NDA	Current
0046-1102	Premarin	estrogens, conjugated	Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.	NDA	Current
0046-1102	Premarin	estrogens, conjugated	Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.	NDA	Current
0046-1102	Premarin	estrogens, conjugated	Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.	NDA	Current
0046-1103	Premarin	estrogens, conjugated	Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.	NDA	Current
0046-1103	Premarin	estrogens, conjugated	Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.	NDA	Current
0046-1103	Premarin	estrogens, conjugated	Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.	NDA	Current
0046-1103	Premarin	estrogens, conjugated	Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.	NDA	Current
0046-1103	Premarin	estrogens, conjugated	Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.	NDA	Current
0046-1104	Premarin	estrogens, conjugated	Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.	NDA	Current
0046-1104	Premarin	estrogens, conjugated	Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.	NDA	Current
0046-1104	Premarin	estrogens, conjugated	Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.	NDA	Current
0046-1104	Premarin	estrogens, conjugated	Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.	NDA	Current
0046-1104	Premarin	estrogens, conjugated	Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.	NDA	Current
43353-687	Premarin	conjugated estrogens	Aphena Pharma Solutions - Tennessee, Inc.	NDA	Current
43353-688	Premarin	conjugated estrogens	Aphena Pharma Solutions - Tennessee, Inc.	NDA	Current
50090-0167	Premarin	estrogens, conjugated	A-S Medication Solutions	NDA	Current
50090-0167	Premarin	estrogens, conjugated	A-S Medication Solutions	NDA	Current
50090-0167	Premarin	estrogens, conjugated	A-S Medication Solutions	NDA	Current
50090-0167	Premarin	estrogens, conjugated	A-S Medication Solutions	NDA	Current
50090-1853	Premarin	estrogens, conjugated	A-S Medication Solutions	NDA	Current
53808-0770	Premarin	conjugated estrogens	State of Florida DOH Central Pharmacy	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
82080	SUPPL	2025-05-01
81995	SUPPL	2025-04-25
77561	SUPPL	2024-02-20
77514	SUPPL	2024-02-16
63858	SUPPL	2020-07-13
50350	SUPPL	2017-11-09
32925	SUPPL	2014-12-10
10	SUPPL	2014-12-04
32924	SUPPL	2011-11-01
32923	SUPPL	2011-11-01
10673	SUPPL	2011-11-01
57	SUPPL	2011-10-31
9	SUPPL	2011-10-31
8	SUPPL	2011-10-31
43992	ORIG	2009-06-02
32922	SUPPL	2008-03-05
56	SUPPL	2008-03-05
40642	SUPPL	2007-04-09
20003	SUPPL	2007-04-09
7	SUPPL	2006-09-18
32921	SUPPL	2006-09-12
32920	SUPPL	2006-04-25
55	SUPPL	2006-04-25
10672	SUPPL	2005-11-03
6	SUPPL	2005-11-03
32919	SUPPL	2005-08-04
5	SUPPL	2005-08-04
32918	SUPPL	2005-04-12
10671	SUPPL	2005-04-12
54	SUPPL	2005-04-12
4	SUPPL	2005-04-12
10669	SUPPL	2004-11-17
10670	SUPPL	2004-08-31
53	SUPPL	2004-08-31
10668	SUPPL	2004-05-04
52	SUPPL	2004-04-29
51	SUPPL	2004-04-29
1	SUPPL	2003-07-28
49	SUPPL	2003-05-16
3	SUPPL	2003-05-16
32917	SUPPL	2003-04-30
10665	SUPPL	2003-04-28
10667	SUPPL	2003-01-07
50	SUPPL	2003-01-07
10666	SUPPL	2002-11-27
2	SUPPL	2002-11-27
40641	SUPPL	1998-09-08
48	SUPPL	1998-09-08