FDA.reportPublic FDA data

Application 074164

Type
ANDA
Sponsor
P AND L

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MICONAZOLE 7MICONAZOLE NITRATECREAM;VAGINAL2%NoNo

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

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
A074164-001MICONAZOLE 7MICONAZOLE NITRATE2%CREAM / VAGINAL1996-03-29

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 2 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10A074164-001MICONAZOLE 72%CREAM / VAGINAL1996-03-29f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A074164-001MICONAZOLE 72%CREAM / VAGINAL1996-03-29e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A074164-001MICONAZOLE 72%CREAM / VAGINAL1996-03-29cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A074164-001MICONAZOLE 72%CREAM / VAGINAL1996-03-29a50c72e98297…

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 · 13 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Miconazole 7MICONAZOLE NITRATEWalgreens0d991104-df96-49b8-b146-67f47b5fcd202026-08-20WarningsExact identifier
application applno (ANDA): 074164
application number: ANDA074164
ndc (product): 0363-0730
Miconazole 7MICONAZOLE NITRATEEQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)0cef9212-201d-4fd2-8afb-ae06ea6b6ee42026-08-20WarningsExact identifier
application applno (ANDA): 074164
application number: ANDA074164
ndc (product): 49035-347
Miconazole 7MICONAZOLE NITRATEPreferred Pharmaceuticals Inc.85a52081-d9cc-44f0-a8d3-851a45c4eb102026-07-08WarningsExact identifier
application applno (ANDA): 074164
application number: ANDA074164
Miconazole 7MICONAZOLE NITRATEPreferred Pharmaceuticals Inc.99c66cbd-7063-4b4c-b827-4f2fcb6ed67f2026-07-08WarningsExact identifier
application applno (ANDA): 074164
application number: ANDA074164
ndc (product): 68788-7917
Miconazole 7MICONAZOLE NITRATEFamily Dollar (FAMILY WELLNESS)c0249750-551a-4ab3-b5f1-409957889c8e2026-03-16WarningsExact identifier
application applno (ANDA): 074164
application number: ANDA074164
Miconazole 7MICONAZOLE NITRATENuCare Pharmaceuticals,Inc.0c055a0d-1031-e7d5-e063-6294a90a17e22025-02-03WarningsExact identifier
application applno (ANDA): 074164
application number: ANDA074164
Miconazole 7MICONAZOLE NITRATEP & L Development, LLCfacc7b65-0376-445a-8a3d-5180f2f9d5ff2024-11-05WarningsExact identifier
application applno (ANDA): 074164
application number: ANDA074164
ndc (product): 59726-988
Miconazole 7MICONAZOLE NITRATEMajor Pharmaceuticals825ac1c5-470e-4ee1-857d-b205c26fc6342024-10-07WarningsExact identifier
application applno (ANDA): 074164
application number: ANDA074164
ndc (product): 0904-7734
Miconazole 7MICONAZOLE NITRATEQUALITY CHOICE (Chain Drug Marketing Association)84bef1d3-e4f8-4769-8f94-5ae91ddc95372024-06-06WarningsExact identifier
application applno (ANDA): 074164
application number: ANDA074164
Miconazole 7MICONAZOLE NITRATECardinal Health (Leader) 700005081411c-02d0-4f7d-8496-d6adccbe00ae2024-03-18WarningsExact identifier
application applno (ANDA): 074164
application number: ANDA074164
ndc (product): 70000-0009
Miconazole 7MICONAZOLE NITRATEH2-Pharma, LLC4bf1a555-a24f-4807-ac13-db19c55cf2802023-01-13WarningsExact identifier
application applno (ANDA): 074164
application number: ANDA074164
ndc (product): 61269-730
Miconazole 7MICONAZOLE NITRATEH2-Pharma, LLC67dc7d38-a663-48d5-9abf-b3bd8dc0eddf2023-01-13WarningsExact identifier
application applno (ANDA): 074164
application number: ANDA074164
ndc (product): 61269-730
Miconazole 7MICONAZOLE NITRATEQUALITY CHOICE (Chain Drug Marketing Association)68667d2e-d4d0-46e7-9d84-0f23fdac1cf72022-09-30WarningsExact identifier
application applno (ANDA): 074164
application number: ANDA074164
ndc (product): 63868-198

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 · 68 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0363-0730Miconazole 7Miconazole NitrateWalgreensANDACurrent
0363-0730Miconazole 7Miconazole NitrateWalgreen CompanyANDACurrent
0363-0730Miconazole 7Miconazole NitrateWalgreensANDACurrent
0363-0730Miconazole 7Miconazole NitrateWalgreensANDACurrent
0472-0730Miconazole 7Miconazole NitrateActavis Pharma, Inc.ANDACurrent
0472-0730Miconazole 7Miconazole NitrateActavis Pharma, Inc.ANDACurrent
0472-0730Miconazole 7Miconazole NitrateActavis Pharma, Inc.ANDACurrent
0472-0730Miconazole 7Miconazole NitrateActavis Pharma, Inc.ANDACurrent
0904-7734Miconazole 7Miconazole NitrateMajor PharmaceuticalsANDACurrent
0904-7734Miconazole 7Miconazole NitrateMajor PharmaceuticalsANDACurrent
0904-7734Miconazole 7Miconazole NitrateMajor PharmaceuticalsANDACurrent
0904-7734Miconazole 7Miconazole NitrateMajor PharmaceuticalsANDACurrent
11822-0730Miconazole 7Miconazole NitrateRite AidANDACurrent
11822-0730Miconazole 7Miconazole NitrateRite Aid CorporationANDACurrent
11822-0730Miconazole 7Miconazole NitrateRite AidANDACurrent
11822-0730Miconazole 7Miconazole NitrateRite Aid CorporationANDACurrent
11822-0730Miconazole 7Miconazole NitrateRite Aid CorporationANDACurrent
49035-347Miconazole 7Miconazole NitrateEQUATE (Wal-Mart Stores, Inc.)ANDACurrent
49035-347Miconazole 7Miconazole NitrateEQUATE (Wal-Mart Stores, Inc.)ANDACurrent
49035-347Miconazole 7Miconazole NitrateEQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)ANDACurrent
49035-730Miconazole 7Miconazole NitrateWal-Mart Stores IncANDACurrent
49035-730Miconazole 7Miconazole NitrateEQUATE (Wal-Mart Stores, Inc.)ANDACurrent
49781-064Miconazole 7Miconazole NitrateCardinal Health (Leader) 49781ANDACurrent
49781-064Miconazole 7Miconazole NitrateCardinal Health (Leader)ANDACurrent
49781-064Miconazole 7Miconazole NitrateCardinal Health (Leader) 49781ANDACurrent
49781-064Miconazole 7Miconazole NitrateCardinal Health (Leader) 49781ANDACurrent
50090-2938Miconazole 7Miconazole NitrateA-S Medication SolutionsANDACurrent
55315-730Miconazole 7Miconazole NitrateFred's Inc.ANDACurrent
55319-730Miconazole 7Miconazole NitrateFamily Dollar (FAMILY WELLNESS)ANDACurrent
55319-730Miconazole 7Miconazole NitrateFamily Dollar Services Inc.ANDACurrent
55319-730Miconazole 7Miconazole NitrateFamily Dollar (FAMILY WELLNESS)ANDACurrent
55319-730Miconazole 7Miconazole NitrateFamily Dollar (FAMILY WELLNESS)ANDACurrent
59726-988Miconazole 7Miconazole NitrateP & L Development, LLCANDACurrent
59726-988Miconazole 7Miconazole NitrateP & L Development, LLCANDACurrent
61269-730Miconazole 7Miconazole NitrateH2-Pharma, LLCANDACurrent
61269-730Miconazole 7Miconazole NitrateH2-Pharma, LLCANDACurrent
63868-198Miconazole 7Miconazole NitrateQUALITY CHOICE (Chain Drug Marketing Association)ANDACurrent
63868-198Miconazole 7Miconazole NitrateChain Drug Marketing Association Inc.ANDACurrent
63868-198Miconazole 7Miconazole NitrateQUALITY CHOICE (Chain Drug Marketing Association)ANDACurrent
63868-198Miconazole 7Miconazole NitrateQUALITY CHOICE (Chain Drug Marketing Association)ANDACurrent
68016-073Miconazole 7Miconazole NitrateChain Drug Consortium, LLCANDACurrent
68016-073Miconazole 7Miconazole NitrateChain Drug Consortium, LLCANDACurrent
68016-073Miconazole 7Miconazole NitrateChain Drug Consortium, LLCANDACurrent
68016-073Miconazole 7Miconazole NitrateChain Drug Consortium, LLCANDACurrent
68071-1703Miconazole 7Miconazole NitrateNuCare Pharmaceuticals,Inc.ANDACurrent
68071-1703Miconazole 7Miconazole NitrateNuCare Pharmaceuticals,Inc.ANDACurrent
68071-1703Miconazole 7Miconazole NitrateNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2419Miconazole 7Miconazole NitrateNuCare Pharmaceuticals,Inc.ANDACurrent
68071-3219Miconazole 7Miconazole NitrateNuCare Pharmaceuticals,Inc.ANDACurrent
68788-7519Miconazole 7Miconazole NitratePreferred Pharmaceuticals, Inc..ANDACurrent
68788-7519Miconazole 7Miconazole NitratePreferred Pharmaceuticals, Inc..ANDACurrent
68788-7519Miconazole 7Miconazole NitratePreferred Pharmaceuticals, Inc..ANDACurrent
68788-7519Miconazole 7Miconazole NitratePreferred Pharmaceuticals, Inc..ANDACurrent
68788-7917Miconazole 7Miconazole NitratePreferred Pharmaceuticals Inc.ANDACurrent
68788-7917Miconazole 7Miconazole NitratePreferred Pharmaceuticals Inc.ANDACurrent
68788-9772Miconazole 7Miconazole NitratePreferred Pharmaceuticals, Inc.ANDACurrent
70000-0009Miconazole 7Miconazole NitrateCardinal Health (Leader) 70000ANDACurrent
70000-0009Miconazole 7Miconazole NitrateCardinal Health (Leader) 70000ANDACurrent
70000-0009Miconazole 7Miconazole NitrateCardinal Health (Leader) 70000ANDACurrent
70000-0009Miconazole 7Miconazole NitrateCardinal Health (Leader) 70000ANDACurrent
70518-1473Miconazole 7Miconazole NitrateREMEDYREPACK INC.ANDACurrent
70518-1473Miconazole 7Miconazole NitrateREMEDYREPACK INC.ANDACurrent
70518-2396Miconazole 7Miconazole NitrateREMEDYREPACK INC.ANDACurrent
70518-2396Miconazole 7Miconazole NitrateREMEDYREPACK INC.ANDACurrent
70518-2396Miconazole 7Miconazole NitrateREMEDYREPACK INC.ANDACurrent
70518-3202Miconazole 7Miconazole NitrateREMEDYREPACK INC.ANDACurrent
70518-3202Miconazole 7Miconazole NitrateREMEDYREPACK INC.ANDACurrent
70518-3202Miconazole 7Miconazole NitrateREMEDYREPACK INC.ANDACurrent