FDA.reportPublic FDA data

Application 016131

Type
NDA
Sponsor
SANOFI AVENTIS US

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
002CLOMIDCLOMIPHENE CITRATETABLET;ORAL50MGYesNo

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
N016131-002CLOMIDCLOMIPHENE CITRATE50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 1982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 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2022-10-28 04:53 UTC2022-10N016131-002CLOMID50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 1982f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N016131-002CLOMID50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 1982e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N016131-002CLOMID50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 1982cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N016131-002CLOMID50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 1982a50c72e98297…

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 · 8 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Clomiphene CitrateCLOMIPHENE CITRATECamber Pharmaceuticals Inc54f608de-6f14-4120-819e-aeb9350c30702026-07-16Warnings, Adverse reactionsName fallback
generic name: CLOMIPHENE CITRATE
Clomiphene citrateCLOMIPHENE CITRATEANI Pharmaceuticals, Inc.b56e04f0-490d-4f10-a0ed-31c288f4f4c52026-06-09Warnings, Adverse reactionsName fallback
generic name: CLOMIPHENE CITRATE
Clomiphene CitrateCLOMIPHENE CITRATEAccord Healthcare Inc.79f64995-7425-44c6-9f44-f7d20daeff652025-12-01Warnings, Adverse reactionsName fallback
generic name: CLOMIPHENE CITRATE
Clomiphene CitrateCLOMIPHENE CITRATEAdvagen Pharma Ltdc7baae81-74ef-4e36-a454-15e9b0fea7e52025-11-04Warnings, Adverse reactionsName fallback
generic name: CLOMIPHENE CITRATE
MiloPheneCLOMIPHENE CITRATEBurel Pharmaceuticals, LLCb56131e5-efc7-43af-ac13-4a2ae918df4e2025-10-07Warnings, Adverse reactionsName fallback
generic name: CLOMIPHENE CITRATE
Clomiphene CitrateCLOMIPHENE CITRATECosette Pharmaceuticals NC Laboratories, LLC72719958-7454-4c54-9bb4-f3054d0c5d822025-08-21Warnings, Adverse reactionsName fallback
generic name: CLOMIPHENE CITRATE
ClomidCLOMIPHENE CITRATECosette Pharmaceuticals, Inc.2ca373c1-4dba-4126-8616-5c533d606fe52025-01-31Warnings, Adverse reactionsName fallback
brand name: Clomid
generic name: CLOMIPHENE CITRATE
CLOMIDCLOMIPHENE CITRATEA-S Medication Solutionsf15e9918-6001-4150-bd54-1364a6febcb82023-05-31Warnings, Adverse reactionsName fallback
brand name: CLOMID
generic name: CLOMIPHENE CITRATE

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
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50090-0677Clomiphene CitrateClomiphene CitrateA-S Medication SolutionsNDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
82806SUPPL 2025-07-11
50908SUPPL2017-12-27
50760SUPPL2017-12-19
40711SUPPL2016-02-02
421SUPPL2012-10-24
33146SUPPL2012-10-22