Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 086417
Company: DR REDDYS
Company: DR REDDYS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| TESTOSTERONE | TESTOSTERONE | 100MG/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 |
|---|---|---|---|---|---|---|---|
| 07/07/1983 | 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 |
|---|---|---|---|---|---|
| 10/25/2016 | SUPPL-27 | Labeling-Package Insert |
Label is not available on this site. |
||
| 10/27/2016 | SUPPL-26 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/11/2015 | SUPPL-25 | Labeling-Package Insert |
Label is not available on this site. |
||
| 06/19/2014 | SUPPL-24 | Labeling-Package Insert |
Label is not available on this site. |
||
| 02/19/1999 | SUPPL-21 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
| 12/14/1998 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/02/1999 | SUPPL-19 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
| 08/04/1998 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/07/1998 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/08/1998 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/20/1992 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 05/24/1991 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
| 11/02/1989 | SUPPL-13 | Labeling |
Label is not available on this site. |
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| 01/10/1989 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/02/1986 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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| 09/11/1984 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |