Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 076737
Company: ACTAVIS LABS UT INC
Company: ACTAVIS LABS UT INC
| 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 |
| TESTOSTERONE | TESTOSTERONE | 12.5MG/1.25GM ACTUATION | GEL, METERED;TRANSDERMAL | Prescription | BX | 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 |
|---|---|---|---|---|---|---|---|
| 01/27/2006 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/076737ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 06/03/2019 | SUPPL-13 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 06/03/2019 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
||
| 10/28/2015 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
||
| 11/05/2015 | SUPPL-6 | REMS-Modified |
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 |
|---|---|---|---|---|---|---|---|---|
| ANDROGEL | TESTOSTERONE | 25MG/2.5GM PACKET | GEL;TRANSDERMAL | Prescription | Yes | AB1 | 021015 | ABBVIE |
| TESTOSTERONE | TESTOSTERONE | 25MG/2.5GM PACKET | GEL;TRANSDERMAL | Prescription | No | AB1 | 076737 | ACTAVIS LABS UT INC |
GEL;TRANSDERMAL; 50MG/5GM PACKET
TE Code = AB1
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ANDROGEL | TESTOSTERONE | 50MG/5GM PACKET | GEL;TRANSDERMAL | Prescription | Yes | AB1 | 021015 | ABBVIE |
| 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 | 076744 | PAR PHARM |
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