Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 087862
Company: SUN PHARM INDUSTRIES
Company: SUN PHARM INDUSTRIES
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| HYDROXYZINE HYDROCHLORIDE | HYDROXYZINE HYDROCHLORIDE | 100MG | TABLET;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 |
|---|---|---|---|---|---|---|---|
| 04/18/1983 | 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 |
|---|---|---|---|---|---|
| 11/08/2016 | SUPPL-17 | Labeling-Package Insert |
Label is not available on this site. |
||
| 03/30/2016 | SUPPL-16 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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| 06/03/2014 | SUPPL-15 | Labeling-Package Insert |
Label is not available on this site. |
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| 12/01/1998 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/23/1994 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
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| 10/11/1994 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/03/1992 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/03/1992 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/08/1987 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/01/1987 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
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| 11/20/1984 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |