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PREDNISOLONE ACETATE

ANDA

PREDNISOLONE ACETATE | A216935 | LUPIN LTD

1 strength0 unique patents0 unique exclusivities

Reference Listed Drug: OMNIPRED(TE code: AB)

Citizen Petitions

2 petitions from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from DifGen Pharmaceuticals LLC FDA-2024-P-5583 DifGen Pharmaceuticals LLC filed a citizen petition under section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA require long-term stability studies at refrigerated conditions (5°C ± 3°C) for any ANDA approvals of Prednisolone Ophthalmic Solution 1%, and further req	505(q)	2024-12-03	Denied	DifGen Pharmaceuticals LLC
Citizen Petition from DifGen Pharmaceuticals LLC FDA-2024-P-5254 DifGen Pharmaceuticals LLC filed a citizen petition under section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA refrain from approving any Abbreviated New Drug Application (ANDA) for Prednisolone Ophthalmic Solution 1% without long-term stability studies conducted	505(q)	2024-11-13	Withdrawn	DifGen Pharmaceuticals LLC

Source: Regulations.gov. FDA citizen petitions matched by application number.

API Supply Chain3 active DMFs2 inactive

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

EUROAPI FRANCEPREDNISOLONE ACETATE

DMF 35291979

HENAN LIHUA PHARMACEUTICAL CO LTDPREDNISOLONE ACETATE USP

DMF 285182014

SYMBIOTEC PHARMALAB PRIVATE LTDPREDNISOLONE ACETATE USP

DMF 327282018

DIOSYNTH BVInactivePREDNISOLONE ACETATE MICRO

DMF 39491980

PFIZER INCInactivePREDNISOLONE ACETATE USP,MICRO & NON MICRO

DMF 55041984

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

Products (1)

#001 — 1%

0 patents0 exclusivities▴

SUSPENSION/DROPS;OPHTHALMIC | Approved: Aug 2, 2024

No patent or exclusivity listings for this strength.