Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 077487
Company: TEVA PHARMS
Company: TEVA PHARMS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
FAMCICLOVIR | FAMCICLOVIR | 125MG | TABLET;ORAL | Prescription | AB | No | No |
FAMCICLOVIR | FAMCICLOVIR | 250MG | TABLET;ORAL | Prescription | AB | No | No |
FAMCICLOVIR | FAMCICLOVIR | 500MG | TABLET;ORAL | Prescription | AB | No | 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 |
---|---|---|---|---|---|---|---|
08/24/2007 | ORIG-1 | Approval |
Letter (PDF)
Letter (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/077487s000TAltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/077487s000ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
07/08/2019 | SUPPL-9 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
||
06/27/2013 | SUPPL-7 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
||
07/29/2011 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
||
05/09/2011 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
||
04/29/2009 | SUPPL-3 | Labeling |
Label is not available on this site. |
FAMCICLOVIR
TABLET;ORAL; 125MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
FAMCICLOVIR | FAMCICLOVIR | 125MG | TABLET;ORAL | Prescription | No | AB | 091480 | APOTEX |
FAMCICLOVIR | FAMCICLOVIR | 125MG | TABLET;ORAL | Prescription | No | AB | 091114 | AUROBINDO PHARMA LTD |
FAMCICLOVIR | FAMCICLOVIR | 125MG | TABLET;ORAL | Prescription | No | AB | 202438 | HETERO LABS LTD V |
FAMCICLOVIR | FAMCICLOVIR | 125MG | TABLET;ORAL | Prescription | No | AB | 201022 | MACLEODS PHARMS LTD |
FAMCICLOVIR | FAMCICLOVIR | 125MG | TABLET;ORAL | Prescription | No | AB | 077487 | TEVA PHARMS |
TABLET;ORAL; 250MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
FAMCICLOVIR | FAMCICLOVIR | 250MG | TABLET;ORAL | Prescription | No | AB | 091480 | APOTEX |
FAMCICLOVIR | FAMCICLOVIR | 250MG | TABLET;ORAL | Prescription | No | AB | 091114 | AUROBINDO PHARMA LTD |
FAMCICLOVIR | FAMCICLOVIR | 250MG | TABLET;ORAL | Prescription | No | AB | 202438 | HETERO LABS LTD V |
FAMCICLOVIR | FAMCICLOVIR | 250MG | TABLET;ORAL | Prescription | No | AB | 201022 | MACLEODS PHARMS LTD |
FAMCICLOVIR | FAMCICLOVIR | 250MG | TABLET;ORAL | Prescription | No | AB | 077487 | TEVA PHARMS |
TABLET;ORAL; 500MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
FAMCICLOVIR | FAMCICLOVIR | 500MG | TABLET;ORAL | Prescription | No | AB | 091480 | APOTEX |
FAMCICLOVIR | FAMCICLOVIR | 500MG | TABLET;ORAL | Prescription | No | AB | 091114 | AUROBINDO PHARMA LTD |
FAMCICLOVIR | FAMCICLOVIR | 500MG | TABLET;ORAL | Prescription | No | AB | 202438 | HETERO LABS LTD V |
FAMCICLOVIR | FAMCICLOVIR | 500MG | TABLET;ORAL | Prescription | No | AB | 201022 | MACLEODS PHARMS LTD |
FAMCICLOVIR | FAMCICLOVIR | 500MG | TABLET;ORAL | Prescription | No | AB | 077487 | TEVA PHARMS |