Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 040052
Company: INWOOD LABS
Company: INWOOD LABS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
THEOPHYLLINE | THEOPHYLLINE | 100MG | CAPSULE, EXTENDED RELEASE;ORAL | Discontinued | None | No | No |
THEOPHYLLINE | THEOPHYLLINE | 125MG | CAPSULE, EXTENDED RELEASE;ORAL | Discontinued | None | No | No |
THEOPHYLLINE | THEOPHYLLINE | 200MG | CAPSULE, EXTENDED RELEASE;ORAL | Discontinued | None | No | No |
THEOPHYLLINE | THEOPHYLLINE | 300MG | CAPSULE, 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 |
---|---|---|---|---|---|---|---|
02/14/1994 | 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 |
---|---|---|---|---|---|
01/28/1998 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
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09/22/1997 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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03/11/1997 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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05/27/1999 | SUPPL-3 | Labeling |
Label is not available on this site. |
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07/11/1994 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
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05/19/1994 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |