Drugs@FDA: FDA-Approved Drugs
Company: SAPTALIS PHARMS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
VOSOL HC | ACETIC ACID, GLACIAL; HYDROCORTISONE | 2%;1% | SOLUTION/DROPS;OTIC | 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 |
---|---|---|---|---|---|---|---|
06/23/1961 | ORIG-1 | Approval | Type 4 - New Combination | STANDARD |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
10/16/1997 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
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07/29/1997 | SUPPL-24 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/1997/012770s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1997/012770s024ltr.pdf | |
12/21/1995 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
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08/01/1990 | SUPPL-21 | Labeling |
Label is not available on this site. |
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08/01/1990 | SUPPL-20 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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09/15/1988 | SUPPL-19 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
09/15/1988 | SUPPL-18 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
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06/29/1988 | SUPPL-16 | Labeling |
Label is not available on this site. |
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08/26/1986 | SUPPL-15 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
06/24/1985 | SUPPL-14 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
04/05/1984 | SUPPL-13 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
02/04/1983 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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08/14/1984 | SUPPL-10 | Labeling |
Label is not available on this site. |
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07/25/1978 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
12/04/1978 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
04/07/1976 | SUPPL-6 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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06/02/1975 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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07/16/1974 | SUPPL-4 |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
07/29/1997 | SUPPL-24 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/1997/012770s024lbl.pdf |
VOSOL HC
SOLUTION/DROPS;OTIC; 2%;1%
TE Code = AT
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
HYDROCORTISONE AND ACETIC ACID | ACETIC ACID, GLACIAL; HYDROCORTISONE | 2%;1% | SOLUTION/DROPS;OTIC | Prescription | No | AT | 040609 | COSETTE |
HYDROCORTISONE AND ACETIC ACID | ACETIC ACID, GLACIAL; HYDROCORTISONE | 2%;1% | SOLUTION/DROPS;OTIC | Prescription | Yes | AT | 088759 | TARO |
VOSOL HC | ACETIC ACID, GLACIAL; HYDROCORTISONE | 2%;1% | SOLUTION/DROPS;OTIC | Prescription | Yes | AT | 012770 | SAPTALIS PHARMS |