Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 216981
Company: TORRENT
Company: TORRENT
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
PENCICLOVIR | PENCICLOVIR | 1% | CREAM;TOPICAL | 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 |
---|---|---|---|---|---|---|---|
08/07/2023 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
PENCICLOVIR
CREAM;TOPICAL; 1%
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
DENAVIR | PENCICLOVIR | 1% | CREAM;TOPICAL | Prescription | Yes | AB | 020629 | MYLAN |
PENCICLOVIR | PENCICLOVIR | 1% | CREAM;TOPICAL | Prescription | No | AB | 212710 | TEVA PHARMS USA |
PENCICLOVIR | PENCICLOVIR | 1% | CREAM;TOPICAL | Prescription | No | AB | 216981 | TORRENT |