FDA.reportPublic FDA data

Application 220673

Type
ANDA
Sponsor
ASCENT PHARMS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CLOMIPHENE CITRATECLOMIPHENE CITRATETABLET;ORAL50MGNoNo

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
A220673-001CLOMIPHENE CITRATECLOMIPHENE CITRATE50MGTABLET / ORALAB2026-05-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A220673-001AB

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A220673-001CLOMIPHENE CITRATE50MGTABLET / ORALAB2026-05-15caaa826d4ba7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A220673-001CLOMIPHENE CITRATE50MGTABLET / ORALAB2026-05-15a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A220673-001AB1caaa826d4ba7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A220673-001AB1a50c72e98297…

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 · 10 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Clomiphene CitrateCLOMIPHENE CITRTAEAcetris Pharma Holdings, LLC76c7550a-d527-4925-b19f-d8b52d5674742026-06-29Warnings, Adverse reactionsName fallback
brand name: Clomiphene Citrate
Clomiphene citrateCLOMIPHENE CITRATEANI Pharmaceuticals, Inc.b56e04f0-490d-4f10-a0ed-31c288f4f4c52026-06-09Warnings, Adverse reactionsName fallback
brand name: Clomiphene citrate
generic name: CLOMIPHENE CITRATE
Clomiphene CitrateCLOMIPHENE CITRATEAccord Healthcare Inc.79f64995-7425-44c6-9f44-f7d20daeff652025-12-01Warnings, Adverse reactionsName fallback
brand name: Clomiphene Citrate
generic name: CLOMIPHENE CITRATE
Clomiphene CitrateCLOMIPHENE CITRATEAdvagen Pharma Ltdc7baae81-74ef-4e36-a454-15e9b0fea7e52025-11-04Warnings, Adverse reactionsName fallback
brand name: Clomiphene Citrate
generic name: CLOMIPHENE CITRATE
MiloPheneCLOMIPHENE CITRATEBurel Pharmaceuticals, LLCb56131e5-efc7-43af-ac13-4a2ae918df4e2025-10-07Warnings, Adverse reactionsName fallback
generic name: CLOMIPHENE CITRATE
Clomiphene CitrateCLOMIPHENE CITRTAERISING PHARMA HOLDINGS, INC.086eace1-51db-4d48-976c-9d39ef5be7452025-09-18Warnings, Adverse reactionsName fallback
brand name: Clomiphene Citrate
Clomiphene CitrateCLOMIPHENE CITRATECosette Pharmaceuticals NC Laboratories, LLC72719958-7454-4c54-9bb4-f3054d0c5d822025-08-21Warnings, Adverse reactionsName fallback
brand name: Clomiphene Citrate
generic name: CLOMIPHENE CITRATE
ClomidCLOMIPHENE CITRATECosette Pharmaceuticals, Inc.2ca373c1-4dba-4126-8616-5c533d606fe52025-01-31Warnings, Adverse reactionsName fallback
generic name: CLOMIPHENE CITRATE
Clomiphene CitrateCLOMIPHENE CITRTAEAppco Pharma LLC2d257ec2-827c-4bc2-8f17-cf24520c3cad2024-11-18Warnings, Adverse reactionsName fallback
brand name: Clomiphene Citrate
CLOMIDCLOMIPHENE CITRATEA-S Medication Solutionsf15e9918-6001-4150-bd54-1364a6febcb82023-05-31Warnings, Adverse reactionsName fallback
generic name: CLOMIPHENE CITRATE