Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 087062
Company: WATSON LABS
Company: WATSON LABS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ORPHENADRINE CITRATE | ORPHENADRINE CITRATE | 30MG/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 |
|---|---|---|---|---|---|---|---|
| 07/16/1981 | 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 |
|---|---|---|---|---|---|
| 02/19/1999 | SUPPL-21 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
| 02/02/1999 | SUPPL-20 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
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| 12/04/1996 | SUPPL-19 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
| 02/14/1996 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
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| 10/04/1990 | SUPPL-17 | Labeling |
Label is not available on this site. |
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| 05/22/1990 | SUPPL-16 | Labeling |
Label is not available on this site. |
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| 05/10/1991 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/10/1991 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/10/1991 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
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| 10/05/1988 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
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| 10/05/1988 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
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| 09/28/1987 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
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| 09/28/1987 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/01/1986 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
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| 11/07/1983 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/16/1983 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |