Viewing data from:

LOTEPREDNOL ETABONATE

ANDA

LOTEPREDNOL ETABONATE | A212080 | SENTISS AG

1 strength0 unique patents0 unique exclusivities

Reference Listed Drug: LOTEMAX(TE code: AB)

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 1 NDC

Highest NADAC/Unit

$14.27

per gm

Lowest NADAC/Unit

$14.27

per gm

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
72485063005LOTEPREDNOL 0.5% OPHTHALMC GEL	$14.27	GM	Generic	—	2026-06-17

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

API Supply Chain8 active DMFs2 inactive

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

ZACH SYSTEM SALOTEPREDNOL ETABONATE

DMF 111051994

INDUSTRIALE CHIMICA SRLLOTEPREDNOL ETABONATE

DMF 236722010

AARTI PHARMALABS LTDLOTEPREDNOL ETABONATE

DMF 262492012

FARMABIOS SPALOTEPREDNOL ETABONATE

DMF 269372013

FARMABIOS SPALOTEPREDNOL ETABONATE STERILE MICRONIZED

DMF 277172013

CURIA SPAIN SAULOTEPREDNOL ETABONATE STERILE MICRONIZED

DMF 280312014

SUN PHARMACEUTICAL INDUSTRIES LTDLOTEPREDNOL ETABONATE

DMF 323522018

CHEMO IBERICA SALOTEPREDNOL ETABONATE MICRONIZED STERILE

DMF 388172024

ALP PHARM BEIJING CO LTDInactiveLOTEPREDNOL ETABONATE

DMF 222782008

RELIANCE LIFE SCIENCES PVT LTDInactiveLOTEPREDNOL ETABONATE

DMF 254352011

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 10, 2021	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 0.5%

0 patents0 exclusivities▴

GEL;OPHTHALMIC | Approved: Feb 10, 2021

No patent or exclusivity listings for this strength.