Application 021583

Type: NDA
Sponsor: PHARMACIA AND UPJOHN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DEPO-SUBQ PROVERA 104	MEDROXYPROGESTERONE ACETATE	INJECTABLE;SUBCUTANEOUS	104MG/0.65ML	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
N021583-001	DEPO-SUBQ PROVERA 104	MEDROXYPROGESTERONE ACETATE	104MG/0.65ML	INJECTABLE / SUBCUTANEOUS		RLD, RS	2004-12-17

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 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N021583-001	DEPO-SUBQ PROVERA 104	104MG/0.65ML	INJECTABLE / SUBCUTANEOUS	RLD, RS	2004-12-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021583-001	DEPO-SUBQ PROVERA 104	104MG/0.65ML	INJECTABLE / SUBCUTANEOUS	RLD, RS	2004-12-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021583-001	DEPO-SUBQ PROVERA 104	104MG/0.65ML	INJECTABLE / SUBCUTANEOUS	RLD, RS	2004-12-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021583-001	DEPO-SUBQ PROVERA 104	104MG/0.65ML	INJECTABLE / SUBCUTANEOUS	RLD, RS	2004-12-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021583-001	DEPO-SUBQ PROVERA 104	104MG/0.65ML	INJECTABLE / SUBCUTANEOUS	RLD, RS	2004-12-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021583-001	DEPO-SUBQ PROVERA 104	104MG/0.65ML	INJECTABLE / SUBCUTANEOUS	RLD, RS	2004-12-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021583-001	DEPO-SUBQ PROVERA 104	104MG/0.65ML	INJECTABLE / SUBCUTANEOUS	RLD, RS	2004-12-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021583-001	DEPO-SUBQ PROVERA 104	104MG/0.65ML	INJECTABLE / SUBCUTANEOUS	RLD, RS	2004-12-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021583-001	DEPO-SUBQ PROVERA 104	104MG/0.65ML	INJECTABLE / SUBCUTANEOUS	RLD, RS	2004-12-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021583-001	DEPO-SUBQ PROVERA 104	104MG/0.65ML	INJECTABLE / SUBCUTANEOUS	RLD, RS	2004-12-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021583-001	DEPO-SUBQ PROVERA 104	104MG/0.65ML	INJECTABLE / SUBCUTANEOUS	RLD, RS	2004-12-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021583-001	DEPO-SUBQ PROVERA 104	104MG/0.65ML	INJECTABLE / SUBCUTANEOUS	RLD, RS	2004-12-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021583-001	DEPO-SUBQ PROVERA 104	104MG/0.65ML	INJECTABLE / SUBCUTANEOUS	RLD, RS	2004-12-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021583-001	DEPO-SUBQ PROVERA 104	104MG/0.65ML	INJECTABLE / SUBCUTANEOUS	RLD, RS	2004-12-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021583-001	DEPO-SUBQ PROVERA 104	104MG/0.65ML	INJECTABLE / SUBCUTANEOUS	RLD, RS	2004-12-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021583-001	DEPO-SUBQ PROVERA 104	104MG/0.65ML	INJECTABLE / SUBCUTANEOUS	RLD, RS	2004-12-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021583-001	DEPO-SUBQ PROVERA 104	104MG/0.65ML	INJECTABLE / SUBCUTANEOUS	RLD, RS	2004-12-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021583-001	DEPO-SUBQ PROVERA 104	104MG/0.65ML	INJECTABLE / SUBCUTANEOUS	RLD, RS	2004-12-17	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021583-001	DEPO-SUBQ PROVERA 104	104MG/0.65ML	INJECTABLE / SUBCUTANEOUS	RLD, RS	2004-12-17	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021583-001	DEPO-SUBQ PROVERA 104	104MG/0.65ML	INJECTABLE / SUBCUTANEOUS	RLD, RS	2004-12-17	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021583-001	DEPO-SUBQ PROVERA 104	104MG/0.65ML	INJECTABLE / SUBCUTANEOUS	RLD, RS	2004-12-17	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021583-001	DEPO-SUBQ PROVERA 104	104MG/0.65ML	INJECTABLE / SUBCUTANEOUS	RLD, RS	2004-12-17	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021583-001	DEPO-SUBQ PROVERA 104	104MG/0.65ML	INJECTABLE / SUBCUTANEOUS	RLD, RS	2004-12-17	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021583-001	DEPO-SUBQ PROVERA 104	104MG/0.65ML	INJECTABLE / SUBCUTANEOUS	RLD, RS	2004-12-17	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021583-001	DEPO-SUBQ PROVERA 104	104MG/0.65ML	INJECTABLE / SUBCUTANEOUS	RLD, RS	2004-12-17	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021583-001	DEPO-SUBQ PROVERA 104	104MG/0.65ML	INJECTABLE / SUBCUTANEOUS	RLD, RS	2004-12-17	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021583-001	DEPO-SUBQ PROVERA 104	104MG/0.65ML	INJECTABLE / SUBCUTANEOUS	RLD, RS	2004-12-17	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021583-001	DEPO-SUBQ PROVERA 104	104MG/0.65ML	INJECTABLE / SUBCUTANEOUS	RLD, RS	2004-12-17	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021583-001	DEPO-SUBQ PROVERA 104	104MG/0.65ML	INJECTABLE / SUBCUTANEOUS	RLD, RS	2004-12-17	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021583-001	DEPO-SUBQ PROVERA 104	104MG/0.65ML	INJECTABLE / SUBCUTANEOUS	RLD, RS	2004-12-17	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021583-001	DEPO-SUBQ PROVERA 104	104MG/0.65ML	INJECTABLE / SUBCUTANEOUS	RLD, RS	2004-12-17	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021583-001	DEPO-SUBQ PROVERA 104	104MG/0.65ML	INJECTABLE / SUBCUTANEOUS	RLD, RS	2004-12-17	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021583-001	DEPO-SUBQ PROVERA 104	104MG/0.65ML	INJECTABLE / SUBCUTANEOUS	RLD, RS	2004-12-17	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021583-001	DEPO-SUBQ PROVERA 104	104MG/0.65ML	INJECTABLE / SUBCUTANEOUS	RLD, RS	2004-12-17	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021583-001	DEPO-SUBQ PROVERA 104	104MG/0.65ML	INJECTABLE / SUBCUTANEOUS	RLD, RS	2004-12-17	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021583-001	DEPO-SUBQ PROVERA 104	104MG/0.65ML	INJECTABLE / SUBCUTANEOUS	RLD, RS	2004-12-17	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021583-001	DEPO-SUBQ PROVERA 104	104MG/0.65ML	INJECTABLE / SUBCUTANEOUS	RLD, RS	2004-12-17	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021583-001	DEPO-SUBQ PROVERA 104	104MG/0.65ML	INJECTABLE / SUBCUTANEOUS	RLD, RS	2004-12-17	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021583-001	DEPO-SUBQ PROVERA 104	104MG/0.65ML	INJECTABLE / SUBCUTANEOUS	RLD, RS	2004-12-17	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021583-001	DEPO-SUBQ PROVERA 104	104MG/0.65ML	INJECTABLE / SUBCUTANEOUS	RLD, RS	2004-12-17	`e64feba35796…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N021583-001	6495534	2020-05-15	Drug product	`74a2ff9319b5…`
2020-12-22 03:56 UTC	2020-12	N021583-001	6495534	2020-05-15	Drug product	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021583-001	6495534	2020-05-15	Drug product	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021583-001	6495534	2020-05-15	Drug product	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021583-001	6495534	2020-05-15	Drug product	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021583-001	6495534	2020-05-15	Drug product	`ea99ee380514…`

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
Depo-SubQ Provera	MEDROXYPROGESTERONE ACETATE	Pharmacia & Upjohn Company LLC	390087a6-f3c3-4f0b-a930-79acf412f153	2025-12-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021583 application number: NDA021583 ndc (product): 0009-4709

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0009-4709	Depo-SubQ Provera	medroxyprogesterone acetate	Pharmacia and Upjohn Company LLC	NDA	Current
0009-4709	Depo-SubQ Provera	medroxyprogesterone acetate	Pharmacia and Upjohn Company LLC	NDA	Current
0009-4709	Depo-SubQ Provera	medroxyprogesterone acetate	Pharmacia and Upjohn Company LLC	NDA	Current
0009-4709	Depo-SubQ Provera	medroxyprogesterone acetate	Pharmacia & Upjohn Company LLC	NDA	Current
0009-4709	Depo-SubQ Provera	medroxyprogesterone acetate	Pharmacia and Upjohn Company LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
84449	SUPPL	2025-12-18
84410	SUPPL	2025-12-15
80623	SUPPL	2024-12-18
80600	SUPPL	2024-12-17
79082	SUPPL	2024-07-15
79063	SUPPL	2024-07-15
65578	SUPPL	2020-12-11
65577	SUPPL	2020-12-11
65519	SUPPL	2020-12-08
65518	SUPPL	2020-12-08
61489	SUPPL	2019-12-31
61488	SUPPL	2019-12-31
61487	SUPPL	2019-12-31
61454	SUPPL	2019-12-26
61453	SUPPL	2019-12-26
61452	SUPPL	2019-12-26
52790	SUPPL	2018-03-02
47088	SUPPL	2017-02-01
47082	SUPPL	2017-02-01
46471	SUPPL	2016-12-22
46288	SUPPL	2016-12-20
45557	SUPPL	2016-10-19
45621	SUPPL	2016-10-17
15822	SUPPL	2015-02-03
5781	SUPPL	2015-02-02
15823	SUPPL	2015-01-29
5782	SUPPL	2015-01-26
28175	SUPPL	2009-07-17
15821	SUPPL	2009-07-16
15820	SUPPL	2007-10-10
5780	SUPPL	2007-10-10
42218	ORIG	2007-05-09
5779	SUPPL	2005-11-18
15819	SUPPL	2005-11-16
28174	SUPPL	2005-05-04
28173	ORIG	2004-12-30
15818	ORIG	2004-12-30