Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 204605
Company: AMNEAL PHARMS
Company: AMNEAL PHARMS
| 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 |
|---|---|---|---|---|---|---|---|
| 06/18/2014 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204605Orig1s000ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 08/20/2015 | SUPPL-1 | Labeling-Package Insert |
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 PHARMS SA |
| 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 |