Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 208061
Company: LUPIN LTD
Company: LUPIN LTD
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
TESTOSTERONE | TESTOSTERONE | 30MG/1.5ML ACTUATION | SOLUTION, METERED;TRANSDERMAL | Prescription | AT | 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 |
---|---|---|---|---|---|---|---|
10/23/2017 | ORIG-1 | Approval | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208061Orig1s000ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
01/29/2020 | SUPPL-4 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
06/04/2019 | SUPPL-2 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
||
05/10/2019 | SUPPL-1 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
TESTOSTERONE
SOLUTION, METERED;TRANSDERMAL; 30MG/1.5ML ACTUATION
TE Code = AT
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
TESTOSTERONE | TESTOSTERONE | 30MG/1.5ML ACTUATION | SOLUTION, METERED;TRANSDERMAL | Prescription | No | AT | 205328 | ACTAVIS LABS UT INC |
TESTOSTERONE | TESTOSTERONE | 30MG/1.5ML ACTUATION | SOLUTION, METERED;TRANSDERMAL | Prescription | No | AT | 209533 | CIPLA |
TESTOSTERONE | TESTOSTERONE | 30MG/1.5ML ACTUATION | SOLUTION, METERED;TRANSDERMAL | Prescription | No | AT | 212301 | ENCUBE |
TESTOSTERONE | TESTOSTERONE | 30MG/1.5ML ACTUATION | SOLUTION, METERED;TRANSDERMAL | Prescription | No | AT | 208061 | LUPIN LTD |
TESTOSTERONE | TESTOSTERONE | 30MG/1.5ML ACTUATION | SOLUTION, METERED;TRANSDERMAL | Prescription | No | AT | 204255 | PADAGIS ISRAEL |
TESTOSTERONE | TESTOSTERONE | 30MG/1.5ML ACTUATION | SOLUTION, METERED;TRANSDERMAL | Prescription | No | AT | 209836 | TWI PHARMS |