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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075440
Company: MYLAN LABS 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
02/28/2000 ORIG-1 Approval Letter (PDF)
Review (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75440ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/075440_ORIGINAL APPROVAL_PACKAGE.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/23/2021 SUPPL-49 Labeling-Package Insert

Label is not available on this site.
12/23/2019 SUPPL-45 Labeling-Package Insert

Label is not available on this site.
12/23/2019 SUPPL-41 Labeling-Package Insert

Label is not available on this site.
12/23/2019 SUPPL-40 Labeling-Package Insert

Label is not available on this site.
09/19/2016 SUPPL-39 Labeling-Package Insert

Label is not available on this site.
09/19/2016 SUPPL-36 Labeling-Package Insert

Label is not available on this site.
11/30/2011 SUPPL-32 Labeling-Package Insert

Label is not available on this site.
02/26/2010 SUPPL-31 Labeling-Package Insert

Label is not available on this site.
01/29/2009 SUPPL-30 Labeling

Label is not available on this site.
08/19/2008 SUPPL-29 Labeling

Label is not available on this site.
04/28/2008 SUPPL-26 Labeling

Label is not available on this site.
12/31/2007 SUPPL-23 Labeling Letter (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/075440s023ltr.pdf
02/09/2007 SUPPL-21 Labeling

Label is not available on this site.
02/11/2005 SUPPL-13 Labeling

Label is not available on this site.
02/11/2005 SUPPL-12

Label is not available on this site.
02/11/2005 SUPPL-11

Label is not available on this site.
02/11/2005 SUPPL-10

Label is not available on this site.
11/26/2002 SUPPL-5 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.
01/02/2002 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.
06/24/2002 SUPPL-3 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.
11/19/2001 SUPPL-1 Labeling

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 074811 HIKMA
HALOPERIDOL DECANOATE HALOPERIDOL DECANOATE EQ 50MG BASE/ML INJECTABLE;INJECTION Prescription No AO 216730 MANKIND PHARMA
HALOPERIDOL DECANOATE HALOPERIDOL DECANOATE EQ 50MG BASE/ML INJECTABLE;INJECTION Prescription No AO 214507 MEITHEAL
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 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 075305 HIKMA
HALOPERIDOL DECANOATE HALOPERIDOL DECANOATE EQ 100MG BASE/ML INJECTABLE;INJECTION Prescription No AO 216730 MANKIND PHARMA
HALOPERIDOL DECANOATE HALOPERIDOL DECANOATE EQ 100MG BASE/ML INJECTABLE;INJECTION Prescription No AO 214507 MEITHEAL
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 211180 ZYDUS PHARMS
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