Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 205469
Company: TARO
Company: TARO
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ACYCLOVIR | ACYCLOVIR | 5% | OINTMENT;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 |
---|---|---|---|---|---|---|---|
12/21/2016 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
ACYCLOVIR
OINTMENT;TOPICAL; 5%
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ACYCLOVIR | ACYCLOVIR | 5% | OINTMENT;TOPICAL | Prescription | No | AB | 209000 | ALEMBIC |
ACYCLOVIR | ACYCLOVIR | 5% | OINTMENT;TOPICAL | Prescription | No | AB | 204605 | AMNEAL PHARMS |
ACYCLOVIR | ACYCLOVIR | 5% | OINTMENT;TOPICAL | Prescription | No | AB | 210774 | APOTEX |
ACYCLOVIR | ACYCLOVIR | 5% | OINTMENT;TOPICAL | Prescription | No | AB | 212495 | CHARTWELL RX |
ACYCLOVIR | ACYCLOVIR | 5% | OINTMENT;TOPICAL | Prescription | No | AB | 211794 | CIPLA |
ACYCLOVIR | ACYCLOVIR | 5% | OINTMENT;TOPICAL | Prescription | No | AB | 206633 | FOUGERA PHARMS INC |
ACYCLOVIR | ACYCLOVIR | 5% | OINTMENT;TOPICAL | Prescription | No | AB | 205510 | GLENMARK SPECLT |
ACYCLOVIR | ACYCLOVIR | 5% | OINTMENT;TOPICAL | Prescription | No | AB | 212444 | MACLEODS PHARMS LTD |
ACYCLOVIR | ACYCLOVIR | 5% | OINTMENT;TOPICAL | Prescription | No | AB | 202459 | MYLAN PHARMS INC |
ACYCLOVIR | ACYCLOVIR | 5% | OINTMENT;TOPICAL | Prescription | No | AB | 205469 | TARO |
ACYCLOVIR | ACYCLOVIR | 5% | OINTMENT;TOPICAL | Prescription | No | AB | 209971 | TORRENT |
ACYCLOVIR | ACYCLOVIR | 5% | OINTMENT;TOPICAL | Prescription | No | AB | 201501 | XIROMED |
ACYCLOVIR | ACYCLOVIR | 5% | OINTMENT;TOPICAL | Prescription | No | AB | 205974 | ZYDUS LIFESCIENCES |
ZOVIRAX | ACYCLOVIR | 5% | OINTMENT;TOPICAL | Prescription | Yes | AB | 018604 | BAUSCH |