Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075807
Company: BEXIMCO PHARMS USA
Company: BEXIMCO PHARMS USA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
FLUOXETINE HYDROCHLORIDE | FLUOXETINE HYDROCHLORIDE | EQ 10MG BASE | CAPSULE;ORAL | Discontinued | None | No | No |
FLUOXETINE HYDROCHLORIDE | FLUOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE;ORAL | Discontinued | None | 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 |
---|---|---|---|---|---|---|---|
01/29/2002 | 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 |
---|---|---|---|---|---|
01/31/2006 | SUPPL-7 | Labeling |
Label is not available on this site. |
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06/07/2005 | SUPPL-5 | Labeling |
Label is not available on this site. |
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06/07/2005 | SUPPL-4 | Labeling |
Label is not available on this site. |
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09/13/2004 | SUPPL-1 | Labeling |
Label is not available on this site. |