Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 205241
Company: GLAND PHARMA LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
HALOPERIDOL DECANOATE HALOPERIDOL DECANOATE EQ 50MG BASE/ML INJECTABLE;INJECTION Prescription AO No No
HALOPERIDOL DECANOATE HALOPERIDOL DECANOATE EQ 100MG BASE/ML INJECTABLE;INJECTION Prescription AO No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
05/12/2017 ORIG-1 Approval STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/29/2019 SUPPL-4 Labeling-Package Insert

Label is not available on this site.

10/29/2019 SUPPL-2 Labeling-Package Insert

Label is not available on this site.

HALOPERIDOL DECANOATE

INJECTABLE;INJECTION; EQ 50MG BASE/ML
TE Code = AO

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
HALDOL HALOPERIDOL DECANOATE EQ 50MG BASE/ML INJECTABLE;INJECTION Prescription Yes AO 018701 JANSSEN PHARMS
HALOPERIDOL DECANOATE HALOPERIDOL DECANOATE EQ 50MG BASE/ML INJECTABLE;INJECTION Prescription No AO 074893 FRESENIUS KABI USA
HALOPERIDOL DECANOATE HALOPERIDOL DECANOATE EQ 50MG BASE/ML INJECTABLE;INJECTION Prescription No AO 205241 GLAND PHARMA LTD
HALOPERIDOL DECANOATE HALOPERIDOL DECANOATE EQ 50MG BASE/ML INJECTABLE;INJECTION Prescription No AO 075440 MYLAN LABS LTD
HALOPERIDOL DECANOATE HALOPERIDOL DECANOATE EQ 50MG BASE/ML INJECTABLE;INJECTION Prescription No AO 209101 SOMERSET THERAPS LLC
HALOPERIDOL DECANOATE HALOPERIDOL DECANOATE EQ 50MG BASE/ML INJECTABLE;INJECTION Prescription No AO 075393 TEVA PHARMS USA
HALOPERIDOL DECANOATE HALOPERIDOL DECANOATE EQ 50MG BASE/ML INJECTABLE;INJECTION Prescription No AO 074811 WEST-WARD PHARMS INT
HALOPERIDOL DECANOATE HALOPERIDOL DECANOATE EQ 50MG BASE/ML INJECTABLE;INJECTION Prescription No AO 211180 ZYDUS PHARMS

INJECTABLE;INJECTION; EQ 100MG BASE/ML
TE Code = AO

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
HALDOL HALOPERIDOL DECANOATE EQ 100MG BASE/ML INJECTABLE;INJECTION Prescription Yes AO 018701 JANSSEN PHARMS
HALOPERIDOL DECANOATE HALOPERIDOL DECANOATE EQ 100MG BASE/ML INJECTABLE;INJECTION Prescription No AO 074893 FRESENIUS KABI USA
HALOPERIDOL DECANOATE HALOPERIDOL DECANOATE EQ 100MG BASE/ML INJECTABLE;INJECTION Prescription No AO 205241 GLAND PHARMA LTD
HALOPERIDOL DECANOATE HALOPERIDOL DECANOATE EQ 100MG BASE/ML INJECTABLE;INJECTION Prescription No AO 075440 MYLAN LABS LTD
HALOPERIDOL DECANOATE HALOPERIDOL DECANOATE EQ 100MG BASE/ML INJECTABLE;INJECTION Prescription No AO 209101 SOMERSET THERAPS LLC
HALOPERIDOL DECANOATE HALOPERIDOL DECANOATE EQ 100MG BASE/ML INJECTABLE;INJECTION Prescription No AO 075393 TEVA PHARMS USA
HALOPERIDOL DECANOATE HALOPERIDOL DECANOATE EQ 100MG BASE/ML INJECTABLE;INJECTION Prescription No AO 075305 WEST-WARD PHARMS INT
HALOPERIDOL DECANOATE HALOPERIDOL DECANOATE EQ 100MG BASE/ML INJECTABLE;INJECTION Prescription No AO 211180 ZYDUS PHARMS

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