Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 209390
Company: TWI PHARMS
Company: TWI PHARMS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
TESTOSTERONE | TESTOSTERONE | 1.62% (20.25MG/1.25GM ACTUATION) | GEL, METERED;TRANSDERMAL | Prescription | AB | 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 |
---|---|---|---|---|---|---|---|
09/23/2019 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
TESTOSTERONE
GEL, METERED;TRANSDERMAL; 1.62% (20.25MG/1.25GM ACTUATION)
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ANDROGEL | TESTOSTERONE | 1.62% (20.25MG/1.25GM ACTUATION) | GEL, METERED;TRANSDERMAL | Prescription | Yes | AB | 022309 | BESINS HLTHCARE |
TESTOSTERONE | TESTOSTERONE | 1.62% (20.25MG/1.25GM ACTUATION) | GEL, METERED;TRANSDERMAL | Prescription | No | AB | 204570 | ACTAVIS LABS UT INC |
TESTOSTERONE | TESTOSTERONE | 1.62% (20.25MG/1.25GM ACTUATION) | GEL, METERED;TRANSDERMAL | Prescription | No | AB | 207373 | AMNEAL |
TESTOSTERONE | TESTOSTERONE | 1.62% (20.25MG/1.25GM ACTUATION) | GEL, METERED;TRANSDERMAL | Prescription | No | AB | 208620 | ENCUBE |
TESTOSTERONE | TESTOSTERONE | 1.62% (20.25MG/1.25GM ACTUATION) | GEL, METERED;TRANSDERMAL | Prescription | No | AB | 208560 | LUPIN |
TESTOSTERONE | TESTOSTERONE | 1.62% (20.25MG/1.25GM ACTUATION) | GEL, METERED;TRANSDERMAL | Prescription | No | AB | 204268 | PADAGIS ISRAEL |
TESTOSTERONE | TESTOSTERONE | 1.62% (20.25MG/1.25GM ACTUATION) | GEL, METERED;TRANSDERMAL | Prescription | No | AB | 209390 | TWI PHARMS |
TESTOSTERONE | TESTOSTERONE | 1.62% (20.25MG/1.25GM ACTUATION) | GEL, METERED;TRANSDERMAL | Prescription | No | AB | 210835 | XIROMED |