Application 020246

Type
NDA
Sponsor
PHARMACIA AND UPJOHN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DEPO-PROVERAMEDROXYPROGESTERONE ACETATEINJECTABLE;INJECTION150MG/MLYesYes

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
N020246-001DEPO-PROVERAMEDROXYPROGESTERONE ACETATE150MG/MLINJECTABLE / INJECTIONABRLD, RS1992-10-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
N020246-001AB

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 06:07:402026-07N020246-001DEPO-PROVERA150MG/MLINJECTABLE / INJECTIONABRLD, RS1992-10-29caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N020246-001DEPO-PROVERA150MG/MLINJECTABLE / INJECTIONABRLD, RS1992-10-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020246-001DEPO-PROVERA150MG/MLINJECTABLE / INJECTIONABRLD, RS1992-10-2931067a03dcf5…
2025-08-23 18:47 UTC2025-08N020246-001DEPO-PROVERA150MG/MLINJECTABLE / INJECTIONABRLD, RS1992-10-296a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020246-001DEPO-PROVERA150MG/MLINJECTABLE / INJECTIONABRLD, RS1992-10-29fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020246-001DEPO-PROVERA150MG/MLINJECTABLE / INJECTIONABRLD, RS1992-10-29b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020246-001DEPO-PROVERA150MG/MLINJECTABLE / INJECTIONABRLD, RS1992-10-2903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020246-001DEPO-PROVERA150MG/MLINJECTABLE / INJECTIONABRLD, RS1992-10-292680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020246-001DEPO-PROVERA150MG/MLINJECTABLE / INJECTIONABRLD, RS1992-10-295bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020246-001DEPO-PROVERA150MG/MLINJECTABLE / INJECTIONABRLD, RS1992-10-29d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N020246-001DEPO-PROVERA150MG/MLINJECTABLE / INJECTIONABRLD, RS1992-10-29d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020246-001DEPO-PROVERA150MG/MLINJECTABLE / INJECTIONABRLD, RS1992-10-2979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020246-001DEPO-PROVERA150MG/MLINJECTABLE / INJECTIONABRLD, RS1992-10-29301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020246-001DEPO-PROVERA150MG/MLINJECTABLE / INJECTIONABRLD, RS1992-10-291e350fbaab3a…
2024-05-31 18:47 UTC2024-05N020246-001DEPO-PROVERA150MG/MLINJECTABLE / INJECTIONABRLD, RS1992-10-298072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N020246-001DEPO-PROVERA150MG/MLINJECTABLE / INJECTIONABRLD, RS1992-10-295c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N020246-001DEPO-PROVERA150MG/MLINJECTABLE / INJECTIONABRLD, RS1992-10-295d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N020246-001DEPO-PROVERA150MG/MLINJECTABLE / INJECTIONABRLD, RS1992-10-294b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N020246-001DEPO-PROVERA150MG/MLINJECTABLE / INJECTIONABRLD, RS1992-10-2974a2ff9319b5…
2022-03-09 01:35 UTC2022-03N020246-001DEPO-PROVERA150MG/MLINJECTABLE / INJECTIONABRLD, RS1992-10-29bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N020246-001DEPO-PROVERA150MG/MLINJECTABLE / INJECTIONABRLD, RS1992-10-29782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N020246-001DEPO-PROVERA150MG/MLINJECTABLE / INJECTIONABRLD, RS1992-10-2987673890dc5c…
2021-03-12 10:30 UTC2021-03N020246-001DEPO-PROVERA150MG/MLINJECTABLE / INJECTIONABRLD, RS1992-10-295aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N020246-001DEPO-PROVERA150MG/MLINJECTABLE / INJECTIONABRLD, RS1992-10-298869cabd3fbd…
2020-11-12 02:37 UTC2020-11N020246-001DEPO-PROVERA150MG/MLINJECTABLE / INJECTIONABRLD, RS1992-10-29c0c555d07b60…
2019-12-14 00:12 UTC2019-12N020246-001DEPO-PROVERA150MG/MLINJECTABLE / INJECTIONABRLD, RS1992-10-293f01610625f2…
2019-09-15 20:21 UTC2019-09N020246-001DEPO-PROVERA150MG/MLINJECTABLE / INJECTIONABRLD, RS1992-10-29b00525d2431f…
2019-07-19 19:46 UTC2019-07N020246-001DEPO-PROVERA150MG/MLINJECTABLE / INJECTIONABRLD, RS1992-10-29ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N020246-001DEPO-PROVERA150MG/MLINJECTABLE / INJECTIONABRLD, RS1992-10-296a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N020246-001DEPO-PROVERA150MG/MLINJECTABLE / INJECTIONABRLD, RS1992-10-291c564ffb4f44…
2023-12-20 04:57 UTC2023-12N020246-001DEPO-PROVERA150MG/MLINJECTABLE / INJECTIONABRLD, RS1992-10-29ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N020246-001DEPO-PROVERA150MG/MLINJECTABLE / INJECTIONABRLD, RS1992-10-29a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N020246-001DEPO-PROVERA150MG/MLINJECTABLE / INJECTIONABRLD, RS1992-10-299b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N020246-001DEPO-PROVERA150MG/MLINJECTABLE / INJECTIONABRLD, RS1992-10-29a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N020246-001DEPO-PROVERA150MG/MLINJECTABLE / INJECTIONABRLD, RS1992-10-293f0d92c62455…
2023-05-13 08:27 UTC2023-05N020246-001DEPO-PROVERA150MG/MLINJECTABLE / INJECTIONABRLD, RS1992-10-29053a50430f4f…
2023-01-26 05:58 UTC2023-01N020246-001DEPO-PROVERA150MG/MLINJECTABLE / INJECTIONABRLD, RS1992-10-293bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N020246-001DEPO-PROVERA150MG/MLINJECTABLE / INJECTIONABRLD, RS1992-10-293a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N020246-001DEPO-PROVERA150MG/MLINJECTABLE / INJECTIONABRLD, RS1992-10-29f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N020246-001DEPO-PROVERA150MG/MLINJECTABLE / INJECTIONABRLD, RS1992-10-29e64feba35796…

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 06:07:402026-07N020246-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N020246-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020246-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N020246-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020246-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020246-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020246-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020246-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020246-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020246-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N020246-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020246-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020246-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020246-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N020246-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N020246-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N020246-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N020246-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N020246-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N020246-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N020246-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N020246-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03N020246-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N020246-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11N020246-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12N020246-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09N020246-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07N020246-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N020246-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N020246-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12N020246-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N020246-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N020246-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N020246-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N020246-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05N020246-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01N020246-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N020246-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N020246-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N020246-001AB1e64feba35796…

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 1 · 4 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 reactionsExact identifier
application applno (NDA): 020246
application number: NDA020246
ndc (product): 66993-370
ndc (product): 66993-371
medroxyprogesterone acetateMEDROXYPROGESTERONE ACETATEA-S Medication Solutions5e817926-ba15-4d16-9463-88f6ff3bd3ac2026-02-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 020246
application number: NDA020246
ndc (product): 50090-5619
Depo-ProveraMEDROXYPROGESTERONE ACETATEPharmacia & Upjohn Company LLC199cf13e-0859-4a73-9b45-e700d0cd10492025-12-18Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 020246
application number: NDA020246
ndc (product): 0009-0746
ndc (product): 0009-7376
medroxyprogesterone acetateMEDROXYPROGESTERONE ACETATEA-S Medication Solutionsca344c55-5251-470f-9243-eceb9e496e3e2023-10-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 020246
application number: NDA020246
ndc (product): 50090-5925

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 45 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0009-0746Depo-Proveramedroxyprogesterone acetatePharmacia and Upjohn Company LLCNDACurrent
0009-0746Depo-Proveramedroxyprogesterone acetatePharmacia and Upjohn Company LLCNDACurrent
0009-0746Depo-Proveramedroxyprogesterone acetatePharmacia & Upjohn Company LLCNDACurrent
0009-0746Depo-Proveramedroxyprogesterone acetatePharmacia & Upjohn Company LLCNDACurrent
0009-0746Depo-Proveramedroxyprogesterone acetatePharmacia and Upjohn Company LLCNDACurrent
0009-7376Depo-Proveramedroxyprogesterone acetatePharmacia and Upjohn Company LLCNDACurrent
0009-7376Depo-Proveramedroxyprogesterone acetatePharmacia and Upjohn Company LLCNDACurrent
0009-7376Depo-Proveramedroxyprogesterone acetatePharmacia & Upjohn Company LLCNDACurrent
0009-7376Depo-Proveramedroxyprogesterone acetatePharmacia & Upjohn Company LLCNDACurrent
0009-7376Depo-Proveramedroxyprogesterone acetatePharmacia and Upjohn Company LLCNDACurrent
50090-0459Depo-Proveramedroxyprogesterone acetateA-S Medication SolutionsNDACurrent
50090-0665Depo-Proveramedroxyprogesterone acetateA-S Medication SolutionsNDACurrent
50090-0665Depo-Proveramedroxyprogesterone acetateA-S Medication SolutionsNDACurrent
50090-0665Depo-Proveramedroxyprogesterone acetateA-S Medication SolutionsNDACurrent
50090-0883medroxyprogesterone acetatemedroxyprogesterone acetateA-S Medication SolutionsNDA AUTHORIZED GENERICCurrent
50090-0883medroxyprogesterone acetatemedroxyprogesterone acetateA-S Medication SolutionsNDA AUTHORIZED GENERICCurrent
50090-0883medroxyprogesterone acetatemedroxyprogesterone acetateA-S Medication SolutionsNDA AUTHORIZED GENERICCurrent
50090-0883medroxyprogesterone acetatemedroxyprogesterone acetateA-S Medication SolutionsNDA AUTHORIZED Current
50090-0883medroxyprogesterone acetatemedroxyprogesterone acetateA-S Medication SolutionsNDA AUTHORIZED GENERICCurrent
50090-3328medroxyprogesterone acetatemedroxyprogesterone acetateA-S Medication SolutionsNDA AUTHORIZED GENERICCurrent
50090-3328medroxyprogesterone acetatemedroxyprogesterone acetateA-S Medication SolutionsNDA AUTHORIZED GENERICCurrent
50090-3328medroxyprogesterone acetatemedroxyprogesterone acetateA-S Medication SolutionsNDA AUTHORIZED GENERICCurrent
50090-3328medroxyprogesterone acetatemedroxyprogesterone acetateA-S Medication SolutionsNDA AUTHORIZED GENERICCurrent
50090-3328medroxyprogesterone acetatemedroxyprogesterone acetateA-S Medication SolutionsNDA AUTHORIZED Current
50090-3328medroxyprogesterone acetatemedroxyprogesterone acetateA-S Medication SolutionsNDA AUTHORIZED GENERICCurrent
50090-5619medroxyprogesterone acetatemedroxyprogesterone acetateA-S Medication SolutionsNDA AUTHORIZED GENERICCurrent
50090-5925medroxyprogesterone acetatemedroxyprogesterone acetateA-S Medication SolutionsNDA AUTHORIZED GENERICCurrent
52125-915medroxyprogesterone acetatemedroxyprogesterone acetateREMEDYREPACK INC.NDA AUTHORIZED GENERICCurrent
59762-4537medroxyprogesterone acetatemedroxyprogesterone acetateGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-4537medroxyprogesterone acetatemedroxyprogesterone acetateGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-4537medroxyprogesterone acetatemedroxyprogesterone acetateGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-4538medroxyprogesterone acetatemedroxyprogesterone acetateGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-4538medroxyprogesterone acetatemedroxyprogesterone acetateGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-4538medroxyprogesterone acetatemedroxyprogesterone acetateGreenstone LLCNDA AUTHORIZED GENERICCurrent
66993-370medroxyprogesterone acetatemedroxyprogesterone acetatePrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-370medroxyprogesterone acetatemedroxyprogesterone acetatePrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-370medroxyprogesterone acetatemedroxyprogesterone acetatePrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-370medroxyprogesterone acetatemedroxyprogesterone acetatePrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-370medroxyprogesterone acetatemedroxyprogesterone acetatePrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-370medroxyprogesterone acetatemedroxyprogesterone acetatePrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-371medroxyprogesterone acetatemedroxyprogesterone acetatePrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
68788-9233medroxyprogesterone acetatemedroxyprogesterone acetatePreferred Pharmaceuticals, IncNDA AUTHORIZED GENERICCurrent
70518-1932medroxyprogesterone acetatemedroxyprogesterone acetateREMEDYREPACK INC.NDA AUTHORIZED GENERICCurrent
70518-1932medroxyprogesterone acetatemedroxyprogesterone acetateREMEDYREPACK INC.NDA AUTHORIZED GENERICCurrent
70518-1932medroxyprogesterone acetatemedroxyprogesterone acetateREMEDYREPACK INC.NDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
84448SUPPL 2025-12-18
84409SUPPL 2025-12-15
79083SUPPL 2024-07-15
79061SUPPL 2024-07-15
77711SUPPL 2024-03-05
77710SUPPL 2024-03-05
65572SUPPL2020-12-10
65571SUPPL2020-12-10
65516SUPPL2020-12-08
65515SUPPL2020-12-08
64545SUPPL2020-09-10
64542SUPPL2020-09-10
64541SUPPL2020-09-10
64539SUPPL2020-09-10
48863SUPPL2017-06-29
47591SUPPL2017-03-20
46451SUPPL2016-12-21
46290SUPPL2016-12-20
12372SUPPL2015-02-03
2243SUPPL2015-02-02
34428SUPPL2015-01-29
24656SUPPL2015-01-26
41230SUPPL2014-08-05
20555SUPPL2014-08-05
20554SUPPL2014-08-05
20553SUPPL2014-08-05
12371SUPPL2011-08-05
24655SUPPL2011-08-01
34427SUPPL2010-10-19
2242SUPPL2010-10-19
24654SUPPL2005-11-01
12368SUPPL2005-11-01
12370SUPPL2004-12-03
2241SUPPL2004-12-02
12369SUPPL2003-06-08
2240SUPPL2003-06-08