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METHYLPREDNISOLONE ACETATE

ANDA

METHYLPREDNISOLONE ACETATE | A220556 | CAPLIN STERILES LTD

2 strengths0 unique patents0 unique exclusivities

Reference Listed Drug: DEPO-MEDROL(TE code: AB)

API Supply Chain7 active DMFs3 inactive

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

EUROAPI FRANCEMETHYLPREDNISOLONE ACETATE

DMF 34521979

PHARMACIA AND UPJOHN CO WHOLLY OWNED SUB PFIZER INCMETHYLPREDNISOLONE ACETATE USP

DMF 48131983

TIANJIN TIANYAO PHARMACEUTICALS CO LTDMETHYLPREDNISOLONE ACETATE (BULK) USP

DMF 189562006

CURIA SPAIN SAUMETHYLPREDNISOLONE ACETATE STERILE MICRONIZED

DMF 238202010

SYMBIOTEC PHARMALAB PRIVATE LTDMETHYLPREDNISOLONE ACETATE USP

DMF 246112011

FARMABIOS SPAMETHYLPREDNISOLONE ACETATE STERILE

DMF 273252013

HIKMA PHARMACEUTICALS PLCMETHYLPREDNISOLONE ACETATE USP (STERILE)

DMF 307892016

DIOSYNTH BVInactiveMETHYLPREDNISOLONE ACETATE

DMF 35961979

SOCIETA ITALIANA CORTICOSTEROIDI SPAInactiveMETHYLPREDNISOLONE ACETATE

DMF 46341982

QUATRUMInactiveMETHYLPREDNISOLONE ACETATE

DMF 68881987

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

Products (2)

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#001 — 40MG/ML

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Jan 26, 2026

No patent or exclusivity listings for this strength.

#002 — 80MG/ML

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Jan 26, 2026