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CALCITRIOL

ANDA

CALCITRIOL | A219796 | HUMANWELL PURACAP PHARMACEUTICAL WUHAN CO LTD

2 strengths0 unique patents0 unique exclusivities

Reference Listed Drug: ROCALTROL(TE code: AB)

API Supply Chain5 active DMFs2 inactive

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

TAPI NL BVCALCITRIOL USP

DMF 124171997

CARBOGEN AMCIS BVCALCITRIOL

DMF 140931999

CERBIOS PHARMA SACALCITRIOL

DMF 147182000

MICROBIOPHARM JAPAN CO LTDCALCITRIOL

DMF 151282000

FORMOSA LABORATORIES INCCALCITRIOL

DMF 182272005

DUPHAR BVInactiveCALCITRIOL

DMF 65471986

CATALENT PHARMA SOLUTIONS LLCInactiveCALCITRIOL 0.25 MCG SOFT GELATIN CAPSULES

DMF 169742003

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Mar 3, 2026	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 0.25MCG

0 patents0 exclusivities▴

CAPSULE;ORAL | Approved: Feb 27, 2026

No patent or exclusivity listings for this strength.

#002 — 0.5MCG

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: Feb 27, 2026