Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 065007
Company: SUN PHARM INDS LTD
Company: SUN PHARM INDS LTD
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
CEPHALEXIN | CEPHALEXIN | EQ 250MG BASE | CAPSULE;ORAL | Discontinued | None | No | No |
CEPHALEXIN | CEPHALEXIN | EQ 500MG BASE | CAPSULE;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 |
---|---|---|---|---|---|---|---|
09/16/1999 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/65007ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
07/02/2004 | SUPPL-15 | Labeling |
Label is not available on this site. |
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11/03/2003 | SUPPL-11 | Labeling |
Label is not available on this site. |
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11/03/2003 | SUPPL-10 | Labeling |
Label is not available on this site. |
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09/05/2001 | SUPPL-6 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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09/05/2001 | SUPPL-5 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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06/29/2000 | SUPPL-4 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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07/18/2000 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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07/18/2000 | SUPPL-2 | Manufacturing (CMC)-Manufacturing Process |
Label is not available on this site. |
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03/01/2000 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |