Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 040086
Company: RHODES PHARMS
Company: RHODES PHARMS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
THEOPHYLLINE | THEOPHYLLINE | 600MG | TABLET, EXTENDED RELEASE;ORAL | Discontinued | None | No | No |
THEOPHYLLINE | THEOPHYLLINE | 400MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | AB | Yes | 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 |
---|---|---|---|---|---|---|---|
04/15/1996 | 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 |
---|---|---|---|---|---|
10/14/2011 | SUPPL-17 | Labeling-Package Insert |
Label is not available on this site. |
||
11/20/2003 | SUPPL-8 | Labeling |
Label is not available on this site. |
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12/19/2002 | SUPPL-7 | Labeling |
Label is not available on this site. |
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08/28/2000 | SUPPL-6 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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08/28/2000 | SUPPL-5 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
08/02/2000 | SUPPL-4 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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08/02/2000 | SUPPL-3 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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08/02/2000 | SUPPL-2 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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08/02/2000 | SUPPL-1 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
THEOPHYLLINE
TABLET, EXTENDED RELEASE;ORAL; 400MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
THEOPHYLLINE | THEOPHYLLINE | 400MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 090355 | GLENMARK PHARMS LTD |
THEOPHYLLINE | THEOPHYLLINE | 400MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 040560 | NOSTRUM LABS INC |
THEOPHYLLINE | THEOPHYLLINE | 400MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 040086 | RHODES PHARMS |