Application 076553

Type: ANDA
Sponsor: TEVA PHARMS USA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	MEDROXYPROGESTERONE ACETATE	MEDROXYPROGESTERONE ACETATE	INJECTABLE;INJECTION	150MG/ML	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A076553-001	MEDROXYPROGESTERONE ACETATE	MEDROXYPROGESTERONE ACETATE	150MG/ML	INJECTABLE / INJECTION	AB		2004-07-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A076553-001	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 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A076553-001	MEDROXYPROGESTERONE ACETATE	150MG/ML	INJECTABLE / INJECTION	AB	2004-07-28	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076553-001	MEDROXYPROGESTERONE ACETATE	150MG/ML	INJECTABLE / INJECTION	AB	2004-07-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076553-001	MEDROXYPROGESTERONE ACETATE	150MG/ML	INJECTABLE / INJECTION	AB	2004-07-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076553-001	MEDROXYPROGESTERONE ACETATE	150MG/ML	INJECTABLE / INJECTION	AB	2004-07-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076553-001	MEDROXYPROGESTERONE ACETATE	150MG/ML	INJECTABLE / INJECTION	AB	2004-07-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076553-001	MEDROXYPROGESTERONE ACETATE	150MG/ML	INJECTABLE / INJECTION	AB	2004-07-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076553-001	MEDROXYPROGESTERONE ACETATE	150MG/ML	INJECTABLE / INJECTION	AB	2004-07-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076553-001	MEDROXYPROGESTERONE ACETATE	150MG/ML	INJECTABLE / INJECTION	AB	2004-07-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076553-001	MEDROXYPROGESTERONE ACETATE	150MG/ML	INJECTABLE / INJECTION	AB	2004-07-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076553-001	MEDROXYPROGESTERONE ACETATE	150MG/ML	INJECTABLE / INJECTION	AB	2004-07-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076553-001	MEDROXYPROGESTERONE ACETATE	150MG/ML	INJECTABLE / INJECTION	AB	2004-07-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076553-001	MEDROXYPROGESTERONE ACETATE	150MG/ML	INJECTABLE / INJECTION	AB	2004-07-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076553-001	MEDROXYPROGESTERONE ACETATE	150MG/ML	INJECTABLE / INJECTION	AB	2004-07-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076553-001	MEDROXYPROGESTERONE ACETATE	150MG/ML	INJECTABLE / INJECTION	AB	2004-07-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076553-001	MEDROXYPROGESTERONE ACETATE	150MG/ML	INJECTABLE / INJECTION	AB	2004-07-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076553-001	MEDROXYPROGESTERONE ACETATE	150MG/ML	INJECTABLE / INJECTION	AB	2004-07-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076553-001	MEDROXYPROGESTERONE ACETATE	150MG/ML	INJECTABLE / INJECTION	AB	2004-07-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076553-001	MEDROXYPROGESTERONE ACETATE	150MG/ML	INJECTABLE / INJECTION	AB	2004-07-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076553-001	MEDROXYPROGESTERONE ACETATE	150MG/ML	INJECTABLE / INJECTION	AB	2004-07-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076553-001	MEDROXYPROGESTERONE ACETATE	150MG/ML	INJECTABLE / INJECTION	AB	2004-07-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076553-001	MEDROXYPROGESTERONE ACETATE	150MG/ML	INJECTABLE / INJECTION	AB	2004-07-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076553-001	MEDROXYPROGESTERONE ACETATE	150MG/ML	INJECTABLE / INJECTION	AB	2004-07-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076553-001	MEDROXYPROGESTERONE ACETATE	150MG/ML	INJECTABLE / INJECTION	AB	2004-07-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076553-001	MEDROXYPROGESTERONE ACETATE	150MG/ML	INJECTABLE / INJECTION	AB	2004-07-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076553-001	MEDROXYPROGESTERONE ACETATE	150MG/ML	INJECTABLE / INJECTION	AB	2004-07-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076553-001	MEDROXYPROGESTERONE ACETATE	150MG/ML	INJECTABLE / INJECTION	AB	2004-07-28	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076553-001	MEDROXYPROGESTERONE ACETATE	150MG/ML	INJECTABLE / INJECTION	AB	2004-07-28	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076553-001	MEDROXYPROGESTERONE ACETATE	150MG/ML	INJECTABLE / INJECTION	AB	2004-07-28	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076553-001	MEDROXYPROGESTERONE ACETATE	150MG/ML	INJECTABLE / INJECTION	AB	2004-07-28	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076553-001	MEDROXYPROGESTERONE ACETATE	150MG/ML	INJECTABLE / INJECTION	AB	2004-07-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076553-001	MEDROXYPROGESTERONE ACETATE	150MG/ML	INJECTABLE / INJECTION	AB	2004-07-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076553-001	MEDROXYPROGESTERONE ACETATE	150MG/ML	INJECTABLE / INJECTION	AB	2004-07-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076553-001	MEDROXYPROGESTERONE ACETATE	150MG/ML	INJECTABLE / INJECTION	AB	2004-07-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076553-001	MEDROXYPROGESTERONE ACETATE	150MG/ML	INJECTABLE / INJECTION	AB	2004-07-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076553-001	MEDROXYPROGESTERONE ACETATE	150MG/ML	INJECTABLE / INJECTION	AB	2004-07-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076553-001	MEDROXYPROGESTERONE ACETATE	150MG/ML	INJECTABLE / INJECTION	AB	2004-07-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076553-001	MEDROXYPROGESTERONE ACETATE	150MG/ML	INJECTABLE / INJECTION	AB	2004-07-28	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076553-001	MEDROXYPROGESTERONE ACETATE	150MG/ML	INJECTABLE / INJECTION	AB	2004-07-28	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076553-001	MEDROXYPROGESTERONE ACETATE	150MG/ML	INJECTABLE / INJECTION	AB	2004-07-28	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076553-001	MEDROXYPROGESTERONE ACETATE	150MG/ML	INJECTABLE / INJECTION	AB	2004-07-28	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A076553-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076553-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076553-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076553-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076553-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076553-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076553-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076553-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076553-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076553-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076553-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076553-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076553-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076553-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076553-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076553-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076553-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076553-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076553-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076553-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076553-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076553-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076553-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076553-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076553-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076553-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076553-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076553-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076553-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076553-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076553-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076553-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076553-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076553-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076553-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076553-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076553-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076553-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076553-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076553-001	AB	1	`f41ea6bd6efb…`

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 2 of 2 · 36 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Medroxyprogesterone Acetate	MEDROXYPROGESTERONE ACETATE	A-S Medication Solutions	788df737-e990-4b5e-accd-af13c3b2bf8b	2025-06-12	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Medroxyprogesterone Acetate 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 brand name: Medroxyprogesterone Acetate generic name: MEDROXYPROGESTERONE ACETATE
Medroxyprogesterone Acetate	MEDROXYPROGESTERONE ACETATE	Coupler LLC	2cf48919-6de8-d3d0-e063-6394a90ac1bc	2025-01-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Medroxyprogesterone Acetate generic name: MEDROXYPROGESTERONE ACETATE
Medroxyprogesterone Acetate Injectable Suspension	MEDROXYPROGESTERONE ACETATE	Hikma Pharmaceuticals USA Inc.	0476eac5-d96c-4910-aa86-1ddeeefefe50	2025-01-08	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MEDROXYPROGESTERONE ACETATE
Medroxyprogesterone Acetate	MEDROXYPROGESTERONE ACETATE	PD-Rx Pharmaceuticals, Inc.	437edd12-2c08-4df4-8cf7-64c47e4779ac	2025-01-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Medroxyprogesterone Acetate generic name: MEDROXYPROGESTERONE ACETATE
Medroxyprogesterone Acetate	MEDROXYPROGESTERONE ACETATE	Bryant Ranch Prepack	a36c89b7-9463-4d00-a4d3-021d77090077	2024-07-08	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Medroxyprogesterone Acetate generic name: MEDROXYPROGESTERONE ACETATE
Medroxyprogesterone Acetate	MEDROXYPROGESTERONE ACETATE	Bryant Ranch Prepack	a88b33ff-842b-4a5b-a27e-9c2b9e85a4d7	2024-07-08	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Medroxyprogesterone Acetate generic name: MEDROXYPROGESTERONE ACETATE
Medroxyprogesterone Acetate	MEDROXYPROGESTERONE ACETATE	Bryant Ranch Prepack	bdb89690-ced2-48e1-bb1a-e5eccfeda8eb	2024-07-08	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Medroxyprogesterone Acetate generic name: MEDROXYPROGESTERONE ACETATE
Medroxyprogesterone Acetate	MEDROXYPROGESTERONE ACETATE	Bryant Ranch Prepack	d9ad130b-8f9a-4a0f-beb4-b692b6d3c5ca	2024-07-08	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Medroxyprogesterone Acetate generic name: MEDROXYPROGESTERONE ACETATE
Medroxyprogesterone Acetate	MEDROXYPROGESTERONE ACETATE	NuCare Pharmaceuticals,Inc.	5c8ffae3-3b3e-197e-e053-2a91aa0a59e3	2024-06-04	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Medroxyprogesterone Acetate generic name: MEDROXYPROGESTERONE ACETATE
Medroxyprogesterone Acetate	MEDROXYPROGESTERONE ACETATE	Teva Pharmaceuticals USA, Inc.	9eb200b0-db96-4a51-87ea-04db862978c8	2024-03-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Medroxyprogesterone Acetate generic name: MEDROXYPROGESTERONE ACETATE
medroxyprogesterone acetate	MEDROXYPROGESTERONE ACETATE	A-S Medication Solutions	ca344c55-5251-470f-9243-eceb9e496e3e	2023-10-23	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: medroxyprogesterone acetate generic name: MEDROXYPROGESTERONE ACETATE
Medroxyprogesterone Acetate	MEDROXYPROGESTERONE ACETATE	Proficient Rx LP	0df6fd1e-7d9c-4a38-848c-1e562e211c91	2023-02-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Medroxyprogesterone Acetate generic name: MEDROXYPROGESTERONE ACETATE
MEDROXYPROGESTERONE ACETATE	MEDROXYPROGESTERONE ACETATE	Sun Pharmaceutical Industries, Inc.	01e28bef-9758-40cf-a4ff-86ae9f4f5105	2022-12-14	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: MEDROXYPROGESTERONE ACETATE generic name: MEDROXYPROGESTERONE ACETATE
MEDROXYPROGESTERONE ACETATE	MEDROXYPROGESTERONE ACETATE	Sun Pharmaceutical Industries, Inc.	d1ea4098-6196-421f-b8e1-bcb31a061e04	2021-06-29	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: MEDROXYPROGESTERONE ACETATE generic name: MEDROXYPROGESTERONE ACETATE
Medroxyprogesterone Acetate	MEDROXYPROGESTERONE ACETATE	Mylan Institutional LLC	60aba812-59eb-4d40-9b6b-d135dca9d36b	2021-03-12	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Medroxyprogesterone Acetate 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 · 13 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0703-6801	Medroxyprogesterone Acetate	Medroxyprogesterone Acetate	Teva Parenteral Medicines, Inc.	ANDA	Current
0703-6801	Medroxyprogesterone Acetate	Medroxyprogesterone Acetate	Teva Parenteral Medicines, Inc.	ANDA	Current
0703-6801	Medroxyprogesterone Acetate	Medroxyprogesterone Acetate	Teva Parenteral Medicines, Inc.	ANDA	Current
0703-6801	Medroxyprogesterone Acetate	Medroxyprogesterone Acetate	Teva Parenteral Medicines, Inc.	ANDA	Current
0703-6801	Medroxyprogesterone Acetate	Medroxyprogesterone Acetate	Teva Parenteral Medicines, Inc.	ANDA	Current
0703-6801	Medroxyprogesterone Acetate	Medroxyprogesterone Acetate	Teva Parenteral Medicines, Inc.	ANDA	Current
16714-028	Medroxyprogesterone Acetate	Medroxyprogesterone Acetate	Northstar RxLLC	ANDA	Current
16714-028	Medroxyprogesterone Acetate	Medroxyprogesterone Acetate	Northstar RxLLC	ANDA	Current
63629-8744	Medroxyprogesterone Acetate	Medroxyprogesterone Acetate	Bryant Ranch Prepack	ANDA	Current
63629-8744	Medroxyprogesterone Acetate	Medroxyprogesterone Acetate	Bryant Ranch Prepack	ANDA	Current
68071-1818	Medroxyprogesterone Acetate	Medroxyprogesterone Acetate	NuCare Pharmaceuticals,Inc.	ANDA	Current
71205-118	Medroxyprogesterone Acetate	Medroxyprogesterone Acetate	Proficient Rx LP	ANDA	Current
71205-118	Medroxyprogesterone Acetate	Medroxyprogesterone Acetate	Proficient Rx LP	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
43087	ORIG	2007-04-02
8923	ORIG	2004-07-30