Application 020527

Type: NDA
Sponsor: WYETH PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PREMPRO	ESTROGENS, CONJUGATED; MEDROXYPROGESTERONE ACETATE	TABLET;ORAL-28	0.625MG;2.5MG	Yes	Yes
002	PREMPHASE 14/14	ESTROGENS, CONJUGATED; MEDROXYPROGESTERONE ACETATE	TABLET;ORAL-28	0.625MG,0.625MG;N/A,5MG	Yes	Yes
003	PREMPRO	ESTROGENS, CONJUGATED; MEDROXYPROGESTERONE ACETATE	TABLET;ORAL-28	0.625MG;5MG	Yes	Yes
004	PREMPRO	ESTROGENS, CONJUGATED; MEDROXYPROGESTERONE ACETATE	TABLET;ORAL-28	0.45MG;1.5MG	Yes	Yes
005	PREMPRO	ESTROGENS, CONJUGATED; MEDROXYPROGESTERONE ACETATE	TABLET;ORAL-28	0.3MG;1.5MG	Yes	Yes

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

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N020527-001	PREMPRO	ESTROGENS, CONJUGATED; MEDROXYPROGESTERONE ACETATE	0.625MG;2.5MG	TABLET / ORAL-28	RLD, RS	1995-11-17
N020527-002	PREMPHASE 14/14	ESTROGENS, CONJUGATED; MEDROXYPROGESTERONE ACETATE	0.625MG,0.625MG;N/A,5MG	TABLET / ORAL-28	RLD, RS	1995-11-17
N020527-003	PREMPRO	ESTROGENS, CONJUGATED; MEDROXYPROGESTERONE ACETATE	0.625MG;5MG	TABLET / ORAL-28	RLD, RS	1998-01-09
N020527-004	PREMPRO	ESTROGENS, CONJUGATED; MEDROXYPROGESTERONE ACETATE	0.45MG;1.5MG	TABLET / ORAL-28	RLD, RS	2003-03-12
N020527-005	PREMPRO	ESTROGENS, CONJUGATED; MEDROXYPROGESTERONE ACETATE	0.3MG;1.5MG	TABLET / ORAL-28	RLD, RS	2003-06-04

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 6 · 205 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	N020527-001	PREMPRO	0.625MG;2.5MG	TABLET / ORAL-28	RLD, RS	1995-11-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020527-002	PREMPHASE 14/14	0.625MG,0.625MG;N/A,5MG	TABLET / ORAL-28	RLD, RS	1995-11-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020527-003	PREMPRO	0.625MG;5MG	TABLET / ORAL-28	RLD, RS	1998-01-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020527-004	PREMPRO	0.45MG;1.5MG	TABLET / ORAL-28	RLD, RS	2003-03-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020527-005	PREMPRO	0.3MG;1.5MG	TABLET / ORAL-28	RLD, RS	2003-06-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020527-001	PREMPRO	0.625MG;2.5MG	TABLET / ORAL-28	RLD, RS	1995-11-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020527-002	PREMPHASE 14/14	0.625MG,0.625MG;N/A,5MG	TABLET / ORAL-28	RLD, RS	1995-11-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020527-003	PREMPRO	0.625MG;5MG	TABLET / ORAL-28	RLD, RS	1998-01-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020527-004	PREMPRO	0.45MG;1.5MG	TABLET / ORAL-28	RLD, RS	2003-03-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020527-005	PREMPRO	0.3MG;1.5MG	TABLET / ORAL-28	RLD, RS	2003-06-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020527-001	PREMPRO	0.625MG;2.5MG	TABLET / ORAL-28	RLD, RS	1995-11-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020527-002	PREMPHASE 14/14	0.625MG,0.625MG;N/A,5MG	TABLET / ORAL-28	RLD, RS	1995-11-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020527-003	PREMPRO	0.625MG;5MG	TABLET / ORAL-28	RLD, RS	1998-01-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020527-004	PREMPRO	0.45MG;1.5MG	TABLET / ORAL-28	RLD, RS	2003-03-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020527-005	PREMPRO	0.3MG;1.5MG	TABLET / ORAL-28	RLD, RS	2003-06-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020527-001	PREMPRO	0.625MG;2.5MG	TABLET / ORAL-28	RLD, RS	1995-11-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020527-002	PREMPHASE 14/14	0.625MG,0.625MG;N/A,5MG	TABLET / ORAL-28	RLD, RS	1995-11-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020527-003	PREMPRO	0.625MG;5MG	TABLET / ORAL-28	RLD, RS	1998-01-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020527-004	PREMPRO	0.45MG;1.5MG	TABLET / ORAL-28	RLD, RS	2003-03-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020527-005	PREMPRO	0.3MG;1.5MG	TABLET / ORAL-28	RLD, RS	2003-06-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020527-001	PREMPRO	0.625MG;2.5MG	TABLET / ORAL-28	RLD, RS	1995-11-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020527-002	PREMPHASE 14/14	0.625MG,0.625MG;N/A,5MG	TABLET / ORAL-28	RLD, RS	1995-11-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020527-003	PREMPRO	0.625MG;5MG	TABLET / ORAL-28	RLD, RS	1998-01-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020527-004	PREMPRO	0.45MG;1.5MG	TABLET / ORAL-28	RLD, RS	2003-03-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020527-005	PREMPRO	0.3MG;1.5MG	TABLET / ORAL-28	RLD, RS	2003-06-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020527-001	PREMPRO	0.625MG;2.5MG	TABLET / ORAL-28	RLD, RS	1995-11-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020527-002	PREMPHASE 14/14	0.625MG,0.625MG;N/A,5MG	TABLET / ORAL-28	RLD, RS	1995-11-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020527-003	PREMPRO	0.625MG;5MG	TABLET / ORAL-28	RLD, RS	1998-01-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020527-004	PREMPRO	0.45MG;1.5MG	TABLET / ORAL-28	RLD, RS	2003-03-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020527-005	PREMPRO	0.3MG;1.5MG	TABLET / ORAL-28	RLD, RS	2003-06-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020527-001	PREMPRO	0.625MG;2.5MG	TABLET / ORAL-28	RLD, RS	1995-11-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020527-002	PREMPHASE 14/14	0.625MG,0.625MG;N/A,5MG	TABLET / ORAL-28	RLD, RS	1995-11-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020527-003	PREMPRO	0.625MG;5MG	TABLET / ORAL-28	RLD, RS	1998-01-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020527-004	PREMPRO	0.45MG;1.5MG	TABLET / ORAL-28	RLD, RS	2003-03-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020527-005	PREMPRO	0.3MG;1.5MG	TABLET / ORAL-28	RLD, RS	2003-06-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020527-001	PREMPRO	0.625MG;2.5MG	TABLET / ORAL-28	RLD, RS	1995-11-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020527-002	PREMPHASE 14/14	0.625MG,0.625MG;N/A,5MG	TABLET / ORAL-28	RLD, RS	1995-11-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020527-003	PREMPRO	0.625MG;5MG	TABLET / ORAL-28	RLD, RS	1998-01-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020527-004	PREMPRO	0.45MG;1.5MG	TABLET / ORAL-28	RLD, RS	2003-03-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020527-005	PREMPRO	0.3MG;1.5MG	TABLET / ORAL-28	RLD, RS	2003-06-04	`5bbf6a4d5a75…`

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
Prempro	CONJUGATED ESTROGENS AND MEDROXYPROGESTERONE ACETATE	Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.	fd0c0836-5d23-2183-da81-9dc7f4287052	2026-04-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 020527 application number: NDA020527 ndc (product): 0046-2575 ndc (product): 0046-1105 ndc (product): 0046-1107 ndc (product): 0046-1108 ndc (product): 0046-1106

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 25 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0046-1105	Prempro	conjugated estrogens and medroxyprogesterone acetate	Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.	NDA	Current
0046-1105	Prempro	CONJUGATED ESTROGENS and MEDROXYPROGESTERONE ACETATE	Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.	NDA	Current
0046-1105	Prempro	conjugated estrogens and medroxyprogesterone acetate	Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.	NDA	Current
0046-1105	Prempro	CONJUGATED ESTROGENS and MEDROXYPROGESTERONE ACETATE	Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.	NDA	Current
0046-1106	Prempro	conjugated estrogens and medroxyprogesterone acetate	Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.	NDA	Current
0046-1106	Prempro	CONJUGATED ESTROGENS and MEDROXYPROGESTERONE ACETATE	Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.	NDA	Current
0046-1106	Prempro	conjugated estrogens and medroxyprogesterone acetate	Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.	NDA	Current
0046-1106	Prempro	CONJUGATED ESTROGENS and MEDROXYPROGESTERONE ACETATE	Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.	NDA	Current
0046-1107	Prempro	conjugated estrogens and medroxyprogesterone acetate	Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.	NDA	Current
0046-1107	Prempro	CONJUGATED ESTROGENS and MEDROXYPROGESTERONE ACETATE	Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.	NDA	Current
0046-1107	Prempro	conjugated estrogens and medroxyprogesterone acetate	Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.	NDA	Current
0046-1107	Prempro	CONJUGATED ESTROGENS and MEDROXYPROGESTERONE ACETATE	Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.	NDA	Current
0046-1108	Prempro	conjugated estrogens and medroxyprogesterone acetate	Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.	NDA	Current
0046-1108	Prempro	CONJUGATED ESTROGENS and MEDROXYPROGESTERONE ACETATE	Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.	NDA	Current
0046-1108	Prempro	conjugated estrogens and medroxyprogesterone acetate	Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.	NDA	Current
0046-1108	Prempro	CONJUGATED ESTROGENS and MEDROXYPROGESTERONE ACETATE	Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.	NDA	Current
0046-2575	Premphase	conjugated estrogens and medroxyprogesterone acetate	Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.	NDA	Current
0046-2575	Premphase	conjugated estrogens and medroxyprogesterone acetate	Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.	NDA	Current
0046-2575	Premphase	conjugated estrogens and medroxyprogesterone acetate	Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.	NDA	Current
0046-2575	Premphase	conjugated estrogens and medroxyprogesterone acetate	Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.	NDA	Current
50090-0573	Prempro	CONJUGATED ESTROGENS and MEDROXYPROGESTERONE ACETATE	A-S Medication Solutions	NDA	Current
50090-0573	Prempro	conjugated estrogens and medroxyprogesterone acetate	A-S Medication Solutions	NDA	Current
68258-5978	Prempro	conjugated estrogens and medroxyprogesterone acetate	Dispensing Solutions, Inc.	NDA	Current
68258-5980	Prempro	conjugated estrogens and medroxyprogesterone acetate	Dispensing Solutions, Inc.	NDA	Current
69189-1107	Prempro	CONJUGATED ESTROGENS and MEDROXYPROGESTERONE ACETATE	Avera McKennan Hospital	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
81985	SUPPL	2025-04-24
77566	SUPPL	2024-02-20
77541	SUPPL	2024-02-16
50298	SUPPL	2017-11-06
50284	SUPPL	2017-11-03
34781	SUPPL	2015-09-04
2674	SUPPL	2015-09-04
20707	SUPPL	2013-01-24
25121	SUPPL	2012-02-07
2673	SUPPL	2012-02-07
2672	SUPPL	2012-02-07
2671	SUPPL	2012-02-07
34780	SUPPL	2012-02-06
34779	SUPPL	2012-02-06
34778	SUPPL	2012-02-06
12686	SUPPL	2012-02-06
41415	SUPPL	2011-01-07
41414	SUPPL	2011-01-07
20706	SUPPL	2011-01-07
25119	SUPPL	2010-01-06
34777	SUPPL	2010-01-04
12685	SUPPL	2009-06-05
23582	ORIG	2009-06-02
25120	SUPPL	2009-05-26
12684	SUPPL	2008-03-05
2670	SUPPL	2008-03-05
34776	SUPPL	2006-08-04
2669	SUPPL	2006-08-04
25118	SUPPL	2005-07-08
12683	SUPPL	2005-07-07
12682	SUPPL	2004-12-29
25117	SUPPL	2004-04-29
2668	SUPPL	2004-04-29
34775	SUPPL	2004-04-23
20705	SUPPL	2003-09-11
34774	SUPPL	2003-06-08
34772	SUPPL	2003-06-08
34771	SUPPL	2003-06-08
25115	SUPPL	2003-06-08
2667	SUPPL	2003-06-08
2665	SUPPL	2003-06-08
34770	SUPPL	2003-03-20
2664	SUPPL	2003-03-18
12681	SUPPL	2003-01-07
2666	SUPPL	2003-01-07
34773	SUPPL	2002-11-27
25116	SUPPL	2002-11-27
25114	SUPPL	2002-02-11
20704	SUPPL	1998-05-12
41413	SUPPL	1998-01-09
25113	SUPPL	1998-01-09
20703	SUPPL	1997-07-31