Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 070698
Company: HOSPIRA
Company: HOSPIRA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| METHYLDOPATE HYDROCHLORIDE | METHYLDOPATE HYDROCHLORIDE | 50MG/ML | 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 |
|---|---|---|---|---|---|---|---|
| 06/15/1987 | 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 |
|---|---|---|---|---|---|
| 03/12/1999 | SUPPL-21 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
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| 08/14/1998 | SUPPL-20 | Labeling |
Label is not available on this site. |
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| 03/12/1999 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/12/1999 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
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| 01/07/1997 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
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| 10/11/1996 | SUPPL-15 | Labeling |
Label is not available on this site. |
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| 05/10/1995 | SUPPL-14 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
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| 11/03/1994 | SUPPL-13 | Labeling |
Label is not available on this site. |
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| 12/22/1993 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
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| 10/30/1992 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/17/1993 | SUPPL-10 | Labeling |
Label is not available on this site. |
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| 04/27/1992 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
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| 09/09/1991 | SUPPL-7 | Labeling |
Label is not available on this site. |
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| 07/15/1988 | SUPPL-6 | Labeling |
Label is not available on this site. |
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| 08/17/1988 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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| 08/17/1988 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
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| 08/17/1988 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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| 11/06/1987 | SUPPL-1 | Labeling |
Label is not available on this site. |