Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 062989
Company: DR REDDYS
Company: DR REDDYS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CEFAZOLIN SODIUM | CEFAZOLIN SODIUM | EQ 5GM BASE/VIAL | INJECTABLE;INJECTION | Discontinued | None | No | No |
| CEFAZOLIN SODIUM | CEFAZOLIN SODIUM | EQ 10GM BASE/VIAL | INJECTABLE;INJECTION | Discontinued | None | No | No |
| CEFAZOLIN SODIUM | CEFAZOLIN SODIUM | EQ 20GM BASE/VIAL | INJECTABLE;INJECTION | 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 |
|---|---|---|---|---|---|---|---|
| 12/29/1989 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 12/08/2000 | SUPPL-21 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 01/05/2000 | SUPPL-20 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 02/19/1999 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
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| 09/29/1998 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
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| 09/18/1998 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/12/1998 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
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| 07/15/1997 | SUPPL-14 | Labeling |
Label is not available on this site. |
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| 06/22/1995 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/22/1994 | SUPPL-11 | Labeling |
Label is not available on this site. |
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| 01/27/1995 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
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| 01/27/1995 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
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| 01/13/1994 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/10/1994 | SUPPL-7 | Labeling |
Label is not available on this site. |
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| 11/19/1993 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/08/1993 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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| 11/20/1992 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |