Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075440
Company: MYLAN LABS LTD
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 | 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 | 211180 | ZYDUS PHARMS |