Drugs@FDA: FDA-Approved Drugs
Company: SUN PHARM INDUSTRIES
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
EQUAGESIC | ASPIRIN; MEPROBAMATE | 325MG;200MG | TABLET;ORAL | Discontinued | None | No | No |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
05/27/1960 | 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 |
---|---|---|---|---|---|
04/28/2021 | SUPPL-40 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/011702s040lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/011702Orig1s040ltr.pdf | |
03/22/2006 | SUPPL-37 | Manufacturing (CMC) |
Label is not available on this site. |
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05/19/2003 | SUPPL-36 | Labeling |
Label is not available on this site. |
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01/27/1988 | SUPPL-33 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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01/22/1988 | SUPPL-32 | Manufacturing (CMC) |
Label is not available on this site. |
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06/08/1987 | SUPPL-31 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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08/12/1986 | SUPPL-30 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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10/29/1985 | SUPPL-29 | Labeling |
Label is not available on this site. |
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12/29/1983 | SUPPL-28 | Labeling |
Label is not available on this site. |
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09/19/1983 | SUPPL-27 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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03/06/1981 | SUPPL-24 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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09/20/1978 | SUPPL-20 | Labeling |
Label is not available on this site. |
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12/15/1978 | SUPPL-19 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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12/15/1978 | SUPPL-18 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
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12/15/1978 | SUPPL-17 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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04/22/1975 | SUPPL-5 | Labeling |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
04/28/2021 | SUPPL-40 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/011702s040lbl.pdf |