Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 084566
Company: MYLAN SPECIALITY LP
Company: MYLAN SPECIALITY LP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| LUFYLLIN | DYPHYLLINE | 200MG | TABLET;ORAL | Discontinued | None | No | No |
| LUFYLLIN | DYPHYLLINE | 400MG | TABLET;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 |
|---|---|---|---|---|---|---|---|
| 08/16/1976 | 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 |
|---|---|---|---|---|---|
| 04/01/2008 | SUPPL-26 | Labeling |
Label is not available on this site. |
||
| 09/18/1992 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/22/1991 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/22/1991 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
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| 09/20/1991 | SUPPL-22 | Labeling |
Label is not available on this site. |
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| 05/17/1989 | SUPPL-21 | Bioequivalence |
Label is not available on this site. |
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| 08/12/1985 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
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| 11/08/1983 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/03/1983 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/22/1984 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/29/1982 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |