Viewing data from:

CLOMIPHENE CITRATE

ANDA

CLOMIPHENE CITRATE | A216545 | RUBICON RESEARCH LTD

1 strength0 unique patents0 unique exclusivities

API Supply Chain5 active DMFs4 inactive

5 active API suppliers hold Drug Master Files for this ingredient.

TAPI NL BVCLOMIPHENE CITRATE

DMF 39571980

FIS FABBRICA ITALIANA SINTETICI SPACLOMIPHENE CITRATE

DMF 56741984

MENADIONA SLCLOMIPHENE CITRATE

DMF 75901988

PCASCLOMIPHENE CITRATE

DMF 289472015

VIYASH LIFE SCIENCES PRIVATE LTDCLOMIPHENE CITRATE USP

DMF 401112024

UNICHEM LABORATORIES LTDInactiveCLOMIPHENE CITRATE

DMF 63361985

EGIS PHARMACEUTICALS PRIVATE LTDInactiveCLOMIPHENE CITRATE USP

DMF 65681986

EGIS PHARMACEUTICALS PRIVATE LTDInactiveCLOMIPHENE CITRATE TABLETS

DMF 86721989

PCASInactiveCLOMIPHENE CITRATE

DMF 147282000

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Products (1)

#001 — 50MG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Nov 12, 2024

No patent or exclusivity listings for this strength.

Change History (2)

Recent changes detected for this application.

MODIFIEDApplicant Full Name7/1/2026

Rubicon Research Private Ltd changed its legal name to Rubicon Research Ltd for clomiphene citrate NDA 216545.

Old: RUBICON RESEARCH PRIVATE LTD

New: RUBICON RESEARCH LTD

MODIFIEDApplicant7/1/2026

Rubicon expanded its official company name from "Rubicon" to "Rubicon Research" for clomiphene citrate (NDA 216545).

Old: RUBICON

New: RUBICON RESEARCH