Application 012541

Type: NDA
Sponsor: PHARMACIA AND UPJOHN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
002	DEPO-PROVERA	MEDROXYPROGESTERONE ACETATE	INJECTABLE;INJECTION	100MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
003	DEPO-PROVERA	MEDROXYPROGESTERONE ACETATE	INJECTABLE;INJECTION	400MG/ML	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N012541-002	DEPO-PROVERA	MEDROXYPROGESTERONE ACETATE	100MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD, Approved before 1982
N012541-003	DEPO-PROVERA	MEDROXYPROGESTERONE ACETATE	400MG/ML	INJECTABLE / INJECTION		RLD, Approved before 1982

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 2 of 3 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N012541-002	DEPO-PROVERA	100MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD, Approved before 1982	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N012541-003	DEPO-PROVERA	400MG/ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N012541-002	DEPO-PROVERA	100MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N012541-003	DEPO-PROVERA	400MG/ML	INJECTABLE / INJECTION	RLD, Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N012541-002	DEPO-PROVERA	100MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD, Approved before 1982	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N012541-003	DEPO-PROVERA	400MG/ML	INJECTABLE / INJECTION	RLD, Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N012541-002	DEPO-PROVERA	100MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD, Approved before 1982	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N012541-003	DEPO-PROVERA	400MG/ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N012541-002	DEPO-PROVERA	100MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD, Approved before 1982	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N012541-003	DEPO-PROVERA	400MG/ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N012541-002	DEPO-PROVERA	100MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD, Approved before 1982	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N012541-003	DEPO-PROVERA	400MG/ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N012541-002	DEPO-PROVERA	100MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD, Approved before 1982	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N012541-003	DEPO-PROVERA	400MG/ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N012541-002	DEPO-PROVERA	100MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD, Approved before 1982	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N012541-003	DEPO-PROVERA	400MG/ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N012541-002	DEPO-PROVERA	100MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD, Approved before 1982	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N012541-003	DEPO-PROVERA	400MG/ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N012541-002	DEPO-PROVERA	100MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD, Approved before 1982	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N012541-003	DEPO-PROVERA	400MG/ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N012541-002	DEPO-PROVERA	100MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N012541-003	DEPO-PROVERA	400MG/ML	INJECTABLE / INJECTION	RLD, Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N012541-002	DEPO-PROVERA	100MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N012541-003	DEPO-PROVERA	400MG/ML	INJECTABLE / INJECTION	RLD, Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N012541-002	DEPO-PROVERA	100MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N012541-003	DEPO-PROVERA	400MG/ML	INJECTABLE / INJECTION	RLD, Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N012541-002	DEPO-PROVERA	100MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N012541-003	DEPO-PROVERA	400MG/ML	INJECTABLE / INJECTION	RLD, Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N012541-002	DEPO-PROVERA	100MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N012541-003	DEPO-PROVERA	400MG/ML	INJECTABLE / INJECTION	RLD, Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N012541-002	DEPO-PROVERA	100MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N012541-003	DEPO-PROVERA	400MG/ML	INJECTABLE / INJECTION	RLD, Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N012541-002	DEPO-PROVERA	100MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N012541-003	DEPO-PROVERA	400MG/ML	INJECTABLE / INJECTION	RLD, Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N012541-002	DEPO-PROVERA	100MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N012541-003	DEPO-PROVERA	400MG/ML	INJECTABLE / INJECTION	RLD, Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N012541-002	DEPO-PROVERA	100MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N012541-003	DEPO-PROVERA	400MG/ML	INJECTABLE / INJECTION	RLD, Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N012541-002	DEPO-PROVERA	100MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N012541-003	DEPO-PROVERA	400MG/ML	INJECTABLE / INJECTION	RLD, Approved before 1982	`3a93d1ddd44b…`

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 2 · 34 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
medroxyprogesterone acetate	MEDROXYPROGESTERONE ACETATE	REMEDYREPACK INC.	a0a92717-c1cb-40eb-a95a-1c5dfd32cfc0	2026-09-04	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MEDROXYPROGESTERONE ACETATE
Medroxyprogesterone Acetate	MEDROXYPROGESTERONE ACETATE	REMEDYREPACK INC.	1020bb60-4f13-4cd7-aaa1-c556752c84b7	2026-08-31	Warnings, Adverse reactions	Name fallback generic name: MEDROXYPROGESTERONE ACETATE
medroxyprogesterone acetate	MEDROXYPROGESTERONE ACETATE	Prasco Laboratories	987496bf-b4b0-409b-b745-f52ed0871f4e	2026-08-25	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MEDROXYPROGESTERONE ACETATE
Depo-Provera	MEDROXYPROGESTERONE ACETATE	Pharmacia & Upjohn Company LLC	199cf13e-0859-4a73-9b45-e700d0cd1049	2026-08-25	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Depo-Provera generic name: MEDROXYPROGESTERONE ACETATE
Medroxyprogesterone Acetate	MEDROXYPROGESTERONE ACETATE	REMEDYREPACK INC.	e3dfd683-d44e-427b-af06-70b9b698e016	2026-07-20	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MEDROXYPROGESTERONE ACETATE
Provera	MEDROXYPROGESTERONE ACETATE	Pharmacia & Upjohn Company LLC	a586be28-96af-4fed-a13f-9b94fd4c7405	2026-06-29	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MEDROXYPROGESTERONE ACETATE
Medroxyprogesterone Acetate	MEDROXYPROGESTERONE ACETATE	Preferred Pharmaceuticals, Inc.	37275fd0-eb24-40a4-a93f-b818bb98414e	2026-06-15	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MEDROXYPROGESTERONE ACETATE
medroxyprogesterone acetate	MEDROXYPROGESTERONE ACETATE	Mylan Pharmaceuticals Inc.	2627eb11-06bf-4a45-9172-094468e3ca07	2026-05-21	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MEDROXYPROGESTERONE ACETATE
medroxyprogesterone acetate	MEDROXYPROGESTERONE ACETATE	A-S Medication Solutions	5e817926-ba15-4d16-9463-88f6ff3bd3ac	2026-02-23	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MEDROXYPROGESTERONE ACETATE
Medroxyprogesterone Acetate	MEDROXYPROGESTERONE ACETATE	Xiromed LLC	24544a5d-0cf5-a099-b57c-6e0843a40532	2026-02-13	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MEDROXYPROGESTERONE ACETATE
medroxyprogesterone acetate	MEDROXYPROGESTERONE ACETATE	Amneal Pharmaceuticals LLC	6457d70a-2f25-4935-8511-726d988f7a03	2026-01-19	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MEDROXYPROGESTERONE ACETATE
MEDROXYPROGESTERONE ACETATE	MEDROXYPROGESTERONE ACETATE	Eugia US LLC	0655670a-d127-4e08-8a23-ace64b2503b2	2026-01-08	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MEDROXYPROGESTERONE ACETATE
Medroxyprogesterone Acetate	MEDROXYPROGESTERONE ACETATE	A-S Medication Solutions	816b9fd2-bc55-496b-846a-cabe7bbdecd6	2026-01-06	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MEDROXYPROGESTERONE ACETATE
Medroxyprogesterone Acetate	MEDROXYPROGESTERONE ACETATE	Northwind Health Company, LLC	0de6142f-a78e-ae58-e063-6394a90adff0	2026-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MEDROXYPROGESTERONE ACETATE
Medroxyprogesterone Acetate	MEDROXYPROGESTERONE ACETATE	Amphastar Pharmaceuticals, Inc.	fda1aa8a-5739-482a-b4f6-9741ef4d9977	2026-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MEDROXYPROGESTERONE ACETATE
Depo-SubQ Provera	MEDROXYPROGESTERONE ACETATE	Pharmacia & Upjohn Company LLC	390087a6-f3c3-4f0b-a930-79acf412f153	2025-12-18	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MEDROXYPROGESTERONE ACETATE
Medroxyprogesterone Acetate	MEDROXYPROGESTERONE ACETATE	PD-Rx Pharmaceuticals, Inc.	6a541749-5d14-44aa-a409-5e51f5bbf929	2025-10-02	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MEDROXYPROGESTERONE ACETATE
Medroxyprogesterone Acetate	MEDROXYPROGESTERONE ACETATE	A-S Medication Solutions	bfdf335d-1cbb-4533-9fde-99a9c71f7504	2025-06-12	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MEDROXYPROGESTERONE ACETATE
Medroxyprogesterone Acetate	MEDROXYPROGESTERONE ACETATE	A-S Medication Solutions	788df737-e990-4b5e-accd-af13c3b2bf8b	2025-06-12	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MEDROXYPROGESTERONE ACETATE
Medroxyprogesterone Acetate	MEDROXYPROGESTERONE ACETATE	Amneal Pharmaceuticals NY LLC	a80560e1-96dd-4380-b3e1-d52719ccdd4b	2025-02-07	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MEDROXYPROGESTERONE ACETATE

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 · 1 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0009-0626	Depo-Provera	medroxyprogesterone acetate	Pharmacia and Upjohn Company LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
47869	SUPPL	2017-04-05
47853	SUPPL	2017-04-04
47599	SUPPL	2017-03-20
47571	SUPPL	2017-03-16
46453	SUPPL	2016-12-21
46235	SUPPL	2016-12-20
12019	SUPPL	2016-06-14
10813	SUPPL	2016-06-13
33086	SUPPL	2015-06-12
12018	SUPPL	2015-06-12