Drugs@FDA: FDA-Approved Drugs
Company: MONARCH PHARMS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
VIROPTIC | TRIFLURIDINE | 1% | SOLUTION/DROPS;OPHTHALMIC | Prescription | AT | 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 |
---|---|---|---|---|---|---|---|
04/10/1980 | 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 |
---|---|---|---|---|---|
03/19/2018 | SUPPL-16 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
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02/20/2002 | SUPPL-14 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18299s014ltr.pdf |
02/10/1997 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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12/31/1996 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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12/10/1996 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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03/06/1997 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
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10/17/1997 | SUPPL-9 | Labeling |
Label is not available on this site. |
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05/08/1995 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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12/30/1991 | SUPPL-6 | Labeling |
Label is not available on this site. |
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12/05/1988 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
03/14/1983 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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08/20/1981 | SUPPL-3 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
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12/30/1980 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
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06/27/1980 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |
VIROPTIC
SOLUTION/DROPS;OPHTHALMIC; 1%
TE Code = AT
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
TRIFLURIDINE | TRIFLURIDINE | 1% | SOLUTION/DROPS;OPHTHALMIC | Prescription | No | AT | 074311 | SANDOZ |
VIROPTIC | TRIFLURIDINE | 1% | SOLUTION/DROPS;OPHTHALMIC | Prescription | Yes | AT | 018299 | MONARCH PHARMS |