Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 087563
Company: MONARCH PHARMS
Company: MONARCH PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| QUIBRON-T/SR | THEOPHYLLINE | 300MG | TABLET, EXTENDED RELEASE;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 |
|---|---|---|---|---|---|---|---|
| 06/21/1983 | 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 |
|---|---|---|---|---|---|
| 05/28/1998 | SUPPL-24 | Labeling |
Label is not available on this site. |
||
| 05/28/1998 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/23/1997 | SUPPL-22 | Labeling |
Label is not available on this site. |
||
| 02/07/1997 | SUPPL-19 | Labeling |
Label is not available on this site. |
||
| 07/22/1996 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/23/1989 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/23/1989 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/23/1989 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/23/1989 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/04/1988 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
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| 09/20/1991 | SUPPL-12 | Labeling |
Label is not available on this site. |
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| 11/17/1986 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/09/1986 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/06/1985 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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| 11/06/1985 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/04/1985 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/06/1984 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/06/1984 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |