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NDA

GONADORELIN HYDROCHLORIDE | N018123 | HIKMA PHARMACEUTICALS USA INC

3 strengths0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Jul 19, 2002	SUPPL -14	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

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#001 — EQ 0.1MG BASE/VIAL

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Sep 30, 1982

No patent or exclusivity listings for this strength.

#002 — EQ 0.2MG BASE/VIAL

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Sep 30, 1982

#003 — EQ 0.5MG BASE/VIAL

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Sep 30, 1982