Application 076553

Type
ANDA
Sponsor
TEVA PHARMS USA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MEDROXYPROGESTERONE ACETATEMEDROXYPROGESTERONE ACETATEINJECTABLE;INJECTION150MG/MLNoNo

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A076553-001MEDROXYPROGESTERONE ACETATEMEDROXYPROGESTERONE ACETATE150MG/MLINJECTABLE / INJECTIONAB2004-07-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A076553-001AB

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A076553-001MEDROXYPROGESTERONE ACETATE150MG/MLINJECTABLE / INJECTIONAB2004-07-28caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A076553-001MEDROXYPROGESTERONE ACETATE150MG/MLINJECTABLE / INJECTIONAB2004-07-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076553-001MEDROXYPROGESTERONE ACETATE150MG/MLINJECTABLE / INJECTIONAB2004-07-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08A076553-001MEDROXYPROGESTERONE ACETATE150MG/MLINJECTABLE / INJECTIONAB2004-07-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076553-001MEDROXYPROGESTERONE ACETATE150MG/MLINJECTABLE / INJECTIONAB2004-07-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076553-001MEDROXYPROGESTERONE ACETATE150MG/MLINJECTABLE / INJECTIONAB2004-07-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076553-001MEDROXYPROGESTERONE ACETATE150MG/MLINJECTABLE / INJECTIONAB2004-07-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076553-001MEDROXYPROGESTERONE ACETATE150MG/MLINJECTABLE / INJECTIONAB2004-07-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076553-001MEDROXYPROGESTERONE ACETATE150MG/MLINJECTABLE / INJECTIONAB2004-07-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076553-001MEDROXYPROGESTERONE ACETATE150MG/MLINJECTABLE / INJECTIONAB2004-07-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076553-001MEDROXYPROGESTERONE ACETATE150MG/MLINJECTABLE / INJECTIONAB2004-07-28d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076553-001MEDROXYPROGESTERONE ACETATE150MG/MLINJECTABLE / INJECTIONAB2004-07-2879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076553-001MEDROXYPROGESTERONE ACETATE150MG/MLINJECTABLE / INJECTIONAB2004-07-28301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076553-001MEDROXYPROGESTERONE ACETATE150MG/MLINJECTABLE / INJECTIONAB2004-07-281e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076553-001MEDROXYPROGESTERONE ACETATE150MG/MLINJECTABLE / INJECTIONAB2004-07-288072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076553-001MEDROXYPROGESTERONE ACETATE150MG/MLINJECTABLE / INJECTIONAB2004-07-285c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A076553-001MEDROXYPROGESTERONE ACETATE150MG/MLINJECTABLE / INJECTIONAB2004-07-285d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A076553-001MEDROXYPROGESTERONE ACETATE150MG/MLINJECTABLE / INJECTIONAB2004-07-284b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A076553-001MEDROXYPROGESTERONE ACETATE150MG/MLINJECTABLE / INJECTIONAB2004-07-2874a2ff9319b5…
2022-03-09 01:35 UTC2022-03A076553-001MEDROXYPROGESTERONE ACETATE150MG/MLINJECTABLE / INJECTIONAB2004-07-28bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A076553-001MEDROXYPROGESTERONE ACETATE150MG/MLINJECTABLE / INJECTIONAB2004-07-28782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A076553-001MEDROXYPROGESTERONE ACETATE150MG/MLINJECTABLE / INJECTIONAB2004-07-2887673890dc5c…
2021-03-12 10:30 UTC2021-03A076553-001MEDROXYPROGESTERONE ACETATE150MG/MLINJECTABLE / INJECTIONAB2004-07-285aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A076553-001MEDROXYPROGESTERONE ACETATE150MG/MLINJECTABLE / INJECTIONAB2004-07-288869cabd3fbd…
2020-11-12 02:37 UTC2020-11A076553-001MEDROXYPROGESTERONE ACETATE150MG/MLINJECTABLE / INJECTIONAB2004-07-28c0c555d07b60…
2019-12-14 00:12 UTC2019-12A076553-001MEDROXYPROGESTERONE ACETATE150MG/MLINJECTABLE / INJECTIONAB2004-07-283f01610625f2…
2019-09-15 20:21 UTC2019-09A076553-001MEDROXYPROGESTERONE ACETATE150MG/MLINJECTABLE / INJECTIONAB2004-07-28b00525d2431f…
2019-07-19 19:46 UTC2019-07A076553-001MEDROXYPROGESTERONE ACETATE150MG/MLINJECTABLE / INJECTIONAB2004-07-28ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A076553-001MEDROXYPROGESTERONE ACETATE150MG/MLINJECTABLE / INJECTIONAB2004-07-286a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A076553-001MEDROXYPROGESTERONE ACETATE150MG/MLINJECTABLE / INJECTIONAB2004-07-281c564ffb4f44…
2023-12-20 04:57 UTC2023-12A076553-001MEDROXYPROGESTERONE ACETATE150MG/MLINJECTABLE / INJECTIONAB2004-07-28ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A076553-001MEDROXYPROGESTERONE ACETATE150MG/MLINJECTABLE / INJECTIONAB2004-07-28a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A076553-001MEDROXYPROGESTERONE ACETATE150MG/MLINJECTABLE / INJECTIONAB2004-07-289b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A076553-001MEDROXYPROGESTERONE ACETATE150MG/MLINJECTABLE / INJECTIONAB2004-07-28a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A076553-001MEDROXYPROGESTERONE ACETATE150MG/MLINJECTABLE / INJECTIONAB2004-07-283f0d92c62455…
2023-05-13 08:27 UTC2023-05A076553-001MEDROXYPROGESTERONE ACETATE150MG/MLINJECTABLE / INJECTIONAB2004-07-28053a50430f4f…
2023-01-26 05:58 UTC2023-01A076553-001MEDROXYPROGESTERONE ACETATE150MG/MLINJECTABLE / INJECTIONAB2004-07-283bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A076553-001MEDROXYPROGESTERONE ACETATE150MG/MLINJECTABLE / INJECTIONAB2004-07-283a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A076553-001MEDROXYPROGESTERONE ACETATE150MG/MLINJECTABLE / INJECTIONAB2004-07-28f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A076553-001MEDROXYPROGESTERONE ACETATE150MG/MLINJECTABLE / INJECTIONAB2004-07-28e64feba35796…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A076553-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A076553-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076553-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A076553-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076553-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076553-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076553-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076553-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076553-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076553-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076553-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076553-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076553-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076553-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076553-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076553-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A076553-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A076553-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A076553-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A076553-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A076553-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A076553-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A076553-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A076553-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A076553-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A076553-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A076553-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A076553-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A076553-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A076553-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A076553-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A076553-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A076553-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A076553-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A076553-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A076553-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A076553-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A076553-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A076553-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A076553-001AB1e64feba35796…

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 · 36 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
medroxyprogesterone acetateMEDROXYPROGESTERONE ACETATEPrasco Laboratories987496bf-b4b0-409b-b745-f52ed0871f4e2026-07-21Boxed warning, Warnings, Adverse reactionsName fallback
brand name: medroxyprogesterone acetate
generic name: MEDROXYPROGESTERONE ACETATE
Medroxyprogesterone AcetateMEDROXYPROGESTERONE ACETATEREMEDYREPACK INC.e3dfd683-d44e-427b-af06-70b9b698e0162026-07-20Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Medroxyprogesterone Acetate
generic name: MEDROXYPROGESTERONE ACETATE
ProveraMEDROXYPROGESTERONE ACETATEPharmacia & Upjohn Company LLCa586be28-96af-4fed-a13f-9b94fd4c74052026-06-29Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MEDROXYPROGESTERONE ACETATE
Medroxyprogesterone AcetateMEDROXYPROGESTERONE ACETATEPreferred Pharmaceuticals Inc.a9e05272-aa4e-4df8-b08b-481abca3e8fd2026-06-15Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Medroxyprogesterone Acetate
generic name: MEDROXYPROGESTERONE ACETATE
Medroxyprogesterone AcetateMEDROXYPROGESTERONE ACETATEPreferred Pharmaceuticals, Inc.37275fd0-eb24-40a4-a93f-b818bb98414e2026-06-15Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Medroxyprogesterone Acetate
generic name: MEDROXYPROGESTERONE ACETATE
Medroxyprogesterone AcetateMEDROXYPROGESTERONE ACETATEREMEDYREPACK INC.1020bb60-4f13-4cd7-aaa1-c556752c84b72026-05-27Warnings, Adverse reactionsName fallback
brand name: Medroxyprogesterone Acetate
generic name: MEDROXYPROGESTERONE ACETATE
medroxyprogesterone acetateMEDROXYPROGESTERONE ACETATEMylan Pharmaceuticals Inc.2627eb11-06bf-4a45-9172-094468e3ca072026-05-21Boxed warning, Warnings, Adverse reactionsName fallback
brand name: medroxyprogesterone acetate
generic name: MEDROXYPROGESTERONE ACETATE
medroxyprogesterone acetateMEDROXYPROGESTERONE ACETATEA-S Medication Solutions5e817926-ba15-4d16-9463-88f6ff3bd3ac2026-02-23Boxed warning, Warnings, Adverse reactionsName fallback
brand name: medroxyprogesterone acetate
generic name: MEDROXYPROGESTERONE ACETATE
Medroxyprogesterone AcetateMEDROXYPROGESTERONE ACETATEXiromed LLC24544a5d-0cf5-a099-b57c-6e0843a405322026-02-13Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Medroxyprogesterone Acetate
generic name: MEDROXYPROGESTERONE ACETATE
medroxyprogesterone acetateMEDROXYPROGESTERONE ACETATEAmneal Pharmaceuticals LLC6457d70a-2f25-4935-8511-726d988f7a032026-01-19Boxed warning, Warnings, Adverse reactionsName fallback
brand name: medroxyprogesterone acetate
generic name: MEDROXYPROGESTERONE ACETATE
MEDROXYPROGESTERONE ACETATEMEDROXYPROGESTERONE ACETATEEugia US LLC0655670a-d127-4e08-8a23-ace64b2503b22026-01-08Boxed warning, Warnings, Adverse reactionsName fallback
brand name: MEDROXYPROGESTERONE ACETATE
generic name: MEDROXYPROGESTERONE ACETATE
Medroxyprogesterone AcetateMEDROXYPROGESTERONE ACETATEA-S Medication Solutions816b9fd2-bc55-496b-846a-cabe7bbdecd62026-01-06Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Medroxyprogesterone Acetate
generic name: MEDROXYPROGESTERONE ACETATE
Medroxyprogesterone AcetateMEDROXYPROGESTERONE ACETATENorthwind Health Company, LLC0de6142f-a78e-ae58-e063-6394a90adff02026-01-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Medroxyprogesterone Acetate
generic name: MEDROXYPROGESTERONE ACETATE
Medroxyprogesterone AcetateMEDROXYPROGESTERONE ACETATEAmphastar Pharmaceuticals, Inc.fda1aa8a-5739-482a-b4f6-9741ef4d99772026-01-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Medroxyprogesterone Acetate
generic name: MEDROXYPROGESTERONE ACETATE
Depo-ProveraMEDROXYPROGESTERONE ACETATEPharmacia & Upjohn Company LLC199cf13e-0859-4a73-9b45-e700d0cd10492025-12-18Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MEDROXYPROGESTERONE ACETATE
Depo-SubQ ProveraMEDROXYPROGESTERONE ACETATEPharmacia & Upjohn Company LLC390087a6-f3c3-4f0b-a930-79acf412f1532025-12-18Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MEDROXYPROGESTERONE ACETATE
Medroxyprogesterone AcetateMEDROXYPROGESTERONE ACETATEAmerican Health Packagingcbf142f9-9af3-4d79-9343-0ab42d6dbe9f2025-11-13Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Medroxyprogesterone Acetate
generic name: MEDROXYPROGESTERONE ACETATE
medroxyprogesterone acetateMEDROXYPROGESTERONE ACETATEREMEDYREPACK INC.a0a92717-c1cb-40eb-a95a-1c5dfd32cfc02025-10-02Boxed warning, Warnings, Adverse reactionsName fallback
brand name: medroxyprogesterone acetate
generic name: MEDROXYPROGESTERONE ACETATE
Medroxyprogesterone AcetateMEDROXYPROGESTERONE ACETATEPD-Rx Pharmaceuticals, Inc.6a541749-5d14-44aa-a409-5e51f5bbf9292025-10-02Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Medroxyprogesterone Acetate
generic name: MEDROXYPROGESTERONE ACETATE
Medroxyprogesterone AcetateMEDROXYPROGESTERONE ACETATEA-S Medication Solutionsbfdf335d-1cbb-4533-9fde-99a9c71f75042025-06-12Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Medroxyprogesterone Acetate
generic name: MEDROXYPROGESTERONE ACETATE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 13 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0703-6801Medroxyprogesterone AcetateMedroxyprogesterone AcetateTeva Parenteral Medicines, Inc.ANDACurrent
0703-6801Medroxyprogesterone AcetateMedroxyprogesterone AcetateTeva Parenteral Medicines, Inc.ANDACurrent
0703-6801Medroxyprogesterone AcetateMedroxyprogesterone AcetateTeva Parenteral Medicines, Inc.ANDACurrent
0703-6801Medroxyprogesterone AcetateMedroxyprogesterone AcetateTeva Parenteral Medicines, Inc.ANDACurrent
0703-6801Medroxyprogesterone AcetateMedroxyprogesterone AcetateTeva Parenteral Medicines, Inc.ANDACurrent
0703-6801Medroxyprogesterone AcetateMedroxyprogesterone AcetateTeva Parenteral Medicines, Inc.ANDACurrent
16714-028Medroxyprogesterone AcetateMedroxyprogesterone AcetateNorthstar RxLLCANDACurrent
16714-028Medroxyprogesterone AcetateMedroxyprogesterone AcetateNorthstar RxLLCANDACurrent
63629-8744Medroxyprogesterone AcetateMedroxyprogesterone AcetateBryant Ranch PrepackANDACurrent
63629-8744Medroxyprogesterone AcetateMedroxyprogesterone AcetateBryant Ranch PrepackANDACurrent
68071-1818Medroxyprogesterone AcetateMedroxyprogesterone AcetateNuCare Pharmaceuticals,Inc.ANDACurrent
71205-118Medroxyprogesterone AcetateMedroxyprogesterone AcetateProficient Rx LPANDACurrent
71205-118Medroxyprogesterone AcetateMedroxyprogesterone AcetateProficient Rx LPANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
43087ORIG2007-04-02
8923ORIG2004-07-30