Drugs@FDA: FDA-Approved Drugs
Company: STRIDES PHARMA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
TESTOSTERONE | TESTOSTERONE | 25MG/2.5GM PACKET | GEL;TRANSDERMAL | Prescription | AB1 | No | No |
TESTOSTERONE | TESTOSTERONE | 50MG/5GM PACKET | GEL;TRANSDERMAL | Prescription | AB1 | 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 |
---|---|---|---|---|---|---|---|
05/23/2007 | ORIG-1 | Approval |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/anda/2007/076744Orig1s000.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
07/16/2024 | SUPPL-18 | Labeling-Patient Package Insert, Labeling-Medication Guide, Labeling-Container/Carton Labels |
Label is not available on this site. |
||
06/03/2019 | SUPPL-10 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
06/03/2019 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
||
06/03/2019 | SUPPL-8 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
06/30/2015 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
||
09/25/2015 | SUPPL-5 | REMS-Proposal |
Label is not available on this site. |
||
06/30/2015 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
||
06/30/2015 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
||
01/06/2009 | SUPPL-1 | Labeling |
Label is not available on this site. |
TESTOSTERONE
GEL;TRANSDERMAL; 25MG/2.5GM PACKET
TE Code = AB1
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
TESTOSTERONE | TESTOSTERONE | 25MG/2.5GM PACKET | GEL;TRANSDERMAL | Prescription | No | AB1 | 076737 | ACTAVIS LABS UT INC |
TESTOSTERONE | TESTOSTERONE | 25MG/2.5GM PACKET | GEL;TRANSDERMAL | Prescription | No | AB1 | 076744 | STRIDES PHARMA |
GEL;TRANSDERMAL; 50MG/5GM PACKET
TE Code = AB1
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
TESTOSTERONE | TESTOSTERONE | 50MG/5GM PACKET | GEL;TRANSDERMAL | Prescription | No | AB1 | 076737 | ACTAVIS LABS UT INC |
TESTOSTERONE | TESTOSTERONE | 50MG/5GM PACKET | GEL;TRANSDERMAL | Prescription | No | AB1 | 212984 | ENCUBE |
TESTOSTERONE | TESTOSTERONE | 50MG/5GM PACKET | GEL;TRANSDERMAL | Prescription | No | AB1 | 076744 | STRIDES PHARMA |