Drugs@FDA: FDA-Approved Drugs
Company: BAUSCH
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ZOVIRAX | ACYCLOVIR | 5% | OINTMENT;TOPICAL | Prescription | AB | Yes | Yes |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
03/29/1982 | ORIG-1 | Approval | Type 1 - New Molecular Entity | PRIORITY |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
09/29/2014 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
||
11/22/2002 | SUPPL-19 | Manufacturing (CMC)-Packaging |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/018604Orig1s019ltr.pdf |
05/30/2001 | SUPPL-18 | Labeling |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/018604s018lbl.pdf | |
07/12/2000 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
05/30/2001 | SUPPL-16 | Labeling |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/018604s018lbl.pdf | |
02/03/1999 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
01/08/1997 | SUPPL-14 | Labeling |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/018604S014.pdf |
10/29/1996 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
11/09/1993 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
01/21/1993 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
07/23/1992 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
01/21/1993 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
11/12/1986 | SUPPL-7 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
04/02/1985 | SUPPL-6 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
12/16/1982 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
07/21/1982 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
06/14/1982 | SUPPL-2 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
05/30/2001 | SUPPL-18 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/018604s018lbl.pdf | |
05/30/2001 | SUPPL-16 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/018604s018lbl.pdf |
ZOVIRAX
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 |