Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 091244
Company: HIKMA FARMACEUTICA
Company: HIKMA FARMACEUTICA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
TESTOSTERONE CYPIONATE | TESTOSTERONE CYPIONATE | 200MG/ML | INJECTABLE;INJECTION | Prescription | AO | 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 |
---|---|---|---|---|---|---|---|
05/01/2012 | ORIG-1 | Approval |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/anda/2012/091244Orig1s000Approv.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
03/27/2017 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
||
07/22/2015 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
||
05/11/2015 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
||
06/19/2014 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
||
07/26/2016 | SUPPL-2 |
Label is not available on this site. |
TESTOSTERONE CYPIONATE
INJECTABLE;INJECTION; 200MG/ML
TE Code = AO
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
DEPO-TESTOSTERONE | TESTOSTERONE CYPIONATE | 200MG/ML | INJECTABLE;INJECTION | Prescription | Yes | AO | 085635 | PFIZER |
TESTOSTERONE CYPIONATE | TESTOSTERONE CYPIONATE | 200MG/ML | INJECTABLE;INJECTION | Prescription | No | AO | 207742 | AM REGENT |
TESTOSTERONE CYPIONATE | TESTOSTERONE CYPIONATE | 200MG/ML | INJECTABLE;INJECTION | Prescription | No | AO | 210362 | CIPLA |
TESTOSTERONE CYPIONATE | TESTOSTERONE CYPIONATE | 200MG/ML | INJECTABLE;INJECTION | Prescription | No | AO | 211817 | EUGIA PHARMA |
TESTOSTERONE CYPIONATE | TESTOSTERONE CYPIONATE | 200MG/ML | INJECTABLE;INJECTION | Prescription | No | AO | 090387 | HIKMA |
TESTOSTERONE CYPIONATE | TESTOSTERONE CYPIONATE | 200MG/ML | INJECTABLE;INJECTION | Prescription | No | AO | 091244 | HIKMA FARMACEUTICA |
TESTOSTERONE CYPIONATE | TESTOSTERONE CYPIONATE | 200MG/ML | INJECTABLE;INJECTION | Prescription | No | AO | 040530 | PADAGIS US |
TESTOSTERONE CYPIONATE | TESTOSTERONE CYPIONATE | 200MG/ML | INJECTABLE;INJECTION | Prescription | No | AO | 040615 | SANDOZ |
TESTOSTERONE CYPIONATE | TESTOSTERONE CYPIONATE | 200MG/ML | INJECTABLE;INJECTION | Prescription | No | AO | 201720 | SUN PHARM INDS LTD |
TESTOSTERONE CYPIONATE | TESTOSTERONE CYPIONATE | 200MG/ML | INJECTABLE;INJECTION | Prescription | No | AO | 086030 | WATSON PHARMS INC |
TESTOSTERONE CYPIONATE | TESTOSTERONE CYPIONATE | 200MG/ML | INJECTABLE;INJECTION | Prescription | No | AO | 206368 | WILSHIRE PHARMS INC |
TESTOSTERONE CYPIONATE | TESTOSTERONE CYPIONATE | 200MG/ML | INJECTABLE;INJECTION | Prescription | No | AO | 215351 | XIROMED |