Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 086748
Company: WOCKHARDT
Company: WOCKHARDT
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| THEOPHYLLINE | THEOPHYLLINE | 80MG/15ML | ELIXIR;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 |
|---|---|---|---|---|---|---|---|
| 01/30/1980 | 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 |
|---|---|---|---|---|---|
| 01/28/1997 | SUPPL-32 | Labeling |
Label is not available on this site. |
||
| 08/22/1995 | SUPPL-31 | Labeling |
Label is not available on this site. |
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| 02/22/1995 | SUPPL-30 | Labeling |
Label is not available on this site. |
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| 06/04/1990 | SUPPL-29 | Labeling |
Label is not available on this site. |
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| 04/26/1989 | SUPPL-28 | Labeling |
Label is not available on this site. |
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| 06/08/1989 | SUPPL-27 | Manufacturing (CMC) |
Label is not available on this site. |
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| 07/21/1988 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/30/1987 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
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| 11/27/1985 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
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| 11/27/1985 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
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| 08/30/1982 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
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| 09/08/1982 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
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| 09/08/1982 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |