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DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE

ANDA

DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE | A216308 | ALEMBIC THERAPEUTICS LLC

1 strength0 unique patents0 unique exclusivities

Reference Listed Drug: COSOPT PF(TE code: AT2)

Products (1)

#001 — EQ 2% BASE;EQ 0.5% BASE

AT2

0 patents0 exclusivities▴

SOLUTION/DROPS;OPHTHALMIC | Approved: Feb 18, 2025

No patent or exclusivity listings for this strength.

Change History (2)

Recent changes detected for this application.

MODIFIEDApplicant Full Name7/1/2026

Alembic Therapeutics LLC replaced New Heights Rx LLC as the applicant for the dorzolamide hydrochloride and timolol maleate combination product (NDA 216308).

Old: NEW HEIGHTSRX LLC

New: ALEMBIC THERAPEUTICS LLC

MODIFIEDApplicant7/1/2026

Alembic Therap became the listed applicant for the dorzolamide hydrochloride and timolol maleate combination product (NDA 216308), replacing New Heights Rx.

Old: NEW HEIGHTSRX

New: ALEMBIC THERAP