Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 085598
Company: WATSON PHARMS INC
Company: WATSON PHARMS INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| TESTOSTERONE ENANTHATE | TESTOSTERONE ENANTHATE | 200MG/ML | INJECTABLE;INJECTION | Prescription | AO | 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 |
|---|---|---|---|---|---|---|---|
| 12/10/1980 | 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 |
|---|---|---|---|---|---|
| 11/02/2020 | SUPPL-54 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/18/2015 | SUPPL-53 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/19/1999 | SUPPL-40 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/19/1999 | SUPPL-38 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
| 02/02/1999 | SUPPL-37 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
| 12/08/1997 | SUPPL-36 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/04/1996 | SUPPL-35 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
| 03/30/1993 | SUPPL-34 | Labeling |
Label is not available on this site. |
||
| 12/11/1991 | SUPPL-33 | Labeling |
Label is not available on this site. |
||
| 05/15/1991 | SUPPL-32 | Labeling |
Label is not available on this site. |
||
| 10/12/1990 | SUPPL-31 | Labeling |
Label is not available on this site. |
||
| 03/12/1990 | SUPPL-30 | Labeling |
Label is not available on this site. |
||
| 06/30/1994 | SUPPL-29 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/30/1994 | SUPPL-28 | Labeling |
Label is not available on this site. |
||
| 04/30/1986 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/28/1985 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/19/1982 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
TESTOSTERONE ENANTHATE
INJECTABLE;INJECTION; 200MG/ML
TE Code = AO
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| TESTOSTERONE ENANTHATE | TESTOSTERONE ENANTHATE | 200MG/ML | INJECTABLE;INJECTION | Prescription | No | AO | 212659 | EUGIA PHARMA |
| TESTOSTERONE ENANTHATE | TESTOSTERONE ENANTHATE | 200MG/ML | INJECTABLE;INJECTION | Prescription | No | AO | 091120 | HIKMA FARMACEUTICA |
| TESTOSTERONE ENANTHATE | TESTOSTERONE ENANTHATE | 200MG/ML | INJECTABLE;INJECTION | Prescription | No | AO | 040575 | NEXUS |
| TESTOSTERONE ENANTHATE | TESTOSTERONE ENANTHATE | 200MG/ML | INJECTABLE;INJECTION | Prescription | No | AO | 085598 | WATSON PHARMS INC |