Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 085186
Company: NOSTRUM LABS INC
Company: NOSTRUM LABS INC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ELIXOPHYLLIN | THEOPHYLLINE | 80MG/15ML | SOLUTION, ELIXIR;ORAL | Prescription | AA | Yes | Yes |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
01/26/1979 | 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 |
---|---|---|---|---|---|
06/26/2014 | SUPPL-25 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
02/18/1999 | SUPPL-18 | Labeling |
Label is not available on this site. |
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02/22/1993 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
02/17/1989 | SUPPL-13 | Labeling |
Label is not available on this site. |
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02/06/1987 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
02/06/1987 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
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05/24/1982 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
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03/05/1982 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
ELIXOPHYLLIN
SOLUTION, ELIXIR;ORAL; 80MG/15ML
TE Code = AA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ELIXOPHYLLIN | THEOPHYLLINE | 80MG/15ML | SOLUTION, ELIXIR;ORAL | Prescription | Yes | AA | 085186 | NOSTRUM LABS INC |
THEOPHYLLINE | THEOPHYLLINE | 80MG/15ML | SOLUTION, ELIXIR;ORAL | Prescription | No | AA | 206344 | PHARM ASSOC |