Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 073037
Company: PHARM ASSOC
Company: PHARM ASSOC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
HALOPERIDOL | HALOPERIDOL LACTATE | EQ 2MG BASE/ML | CONCENTRATE;ORAL | Prescription | AA | No | Yes |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
02/26/1993 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
02/23/2017 | SUPPL-15 | Labeling-Package Insert |
Label is not available on this site. |
||
12/03/2010 | SUPPL-14 | Labeling-Package Insert |
Label is not available on this site. |
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08/18/2010 | SUPPL-13 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
02/26/2010 | SUPPL-12 | Labeling-Package Insert |
Label is not available on this site. |
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03/12/2009 | SUPPL-11 | Labeling |
Label is not available on this site. |
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11/25/2008 | SUPPL-10 | Labeling |
Label is not available on this site. |
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03/27/1995 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
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01/31/1995 | SUPPL-3 | Labeling |
Label is not available on this site. |
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01/31/1995 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
HALOPERIDOL
CONCENTRATE;ORAL; EQ 2MG BASE/ML
TE Code = AA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
HALOPERIDOL | HALOPERIDOL LACTATE | EQ 2MG BASE/ML | CONCENTRATE;ORAL | Prescription | No | AA | 073364 | LANNETT CO INC |
HALOPERIDOL | HALOPERIDOL LACTATE | EQ 2MG BASE/ML | CONCENTRATE;ORAL | Prescription | No | AA | 073037 | PHARM ASSOC |
HALOPERIDOL | HALOPERIDOL LACTATE | EQ 2MG BASE/ML | CONCENTRATE;ORAL | Prescription | No | AA | 218371 | RUBICON |