Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 006823
Company: CASPER PHARMA LLC
Company: CASPER PHARMA LLC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| AQUASOL A | VITAMIN A PALMITATE | EQ 50,000 UNITS BASE/ML | INJECTABLE;INJECTION | Prescription | None | 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 |
|---|---|---|---|---|---|---|---|
| 05/18/1949 | ORIG-1 | Approval | UNKNOWN |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 09/18/2015 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/11/2014 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/01/1999 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/27/1998 | SUPPL-15 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 06/09/2000 | SUPPL-14 | Labeling |
Label is not available on this site. |
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| 02/02/1993 | SUPPL-13 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 12/07/1990 | SUPPL-12 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 07/21/1989 | SUPPL-11 | Labeling |
Label is not available on this site. |
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| 09/19/1984 | SUPPL-9 | Labeling |
Label is not available on this site. |
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| 09/19/1984 | SUPPL-8 | Labeling |
Label is not available on this site. |
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| 10/03/1983 | SUPPL-6 | Labeling |
Label is not available on this site. |
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| 04/20/1982 | SUPPL-5 | Labeling |
Label is not available on this site. |
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| 01/30/1980 | SUPPL-4 | Labeling |
Label is not available on this site. |