Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 085779
Company: DR REDDYS
Company: DR REDDYS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| HYDROXYZINE HYDROCHLORIDE | HYDROXYZINE HYDROCHLORIDE | 50MG/ML | INJECTABLE;INJECTION | 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 |
|---|---|---|---|---|---|---|---|
| 10/05/1979 | 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-96 | Labeling-Package Insert |
Label is not available on this site. |
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| 03/30/2016 | SUPPL-95 | Labeling-Package Insert |
Label is not available on this site. |
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| 06/03/2014 | SUPPL-94 | Labeling-Package Insert |
Label is not available on this site. |
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| 02/19/1999 | SUPPL-92 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
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| 02/02/1999 | SUPPL-91 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
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| 12/04/1996 | SUPPL-90 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
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| 05/23/1991 | SUPPL-89 | Labeling |
Label is not available on this site. |
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| 02/11/1991 | SUPPL-88 | Labeling |
Label is not available on this site. |
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| 11/21/1990 | SUPPL-87 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/04/1989 | SUPPL-86 | Labeling |
Label is not available on this site. |
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| 12/04/1989 | SUPPL-85 | Labeling |
Label is not available on this site. |
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| 08/03/1989 | SUPPL-84 | Labeling |
Label is not available on this site. |
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| 09/21/1988 | SUPPL-82 | Bioequivalence |
Label is not available on this site. |
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| 08/03/1988 | SUPPL-81 | Manufacturing (CMC) |
Label is not available on this site. |
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| 08/03/1988 | SUPPL-80 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/28/1986 | SUPPL-76 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/30/1983 | SUPPL-75 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/08/1982 | SUPPL-73 | Manufacturing (CMC) |
Label is not available on this site. |