Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075188
Company: MYLAN
Company: MYLAN
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
AMIODARONE HYDROCHLORIDE | AMIODARONE HYDROCHLORIDE | 200MG | 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 |
---|---|---|---|---|---|---|---|
02/24/1999 | ORIG-1 | Approval |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/anda/99/75-188_Amiodarone%20Hydrochloride_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/99/75-188_Amiodarone%20Hydrochloride_Approv.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/99/75-188_Amiodarone.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
06/12/2008 | SUPPL-7 | Labeling |
Label is not available on this site. |
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05/05/2005 | SUPPL-6 | Labeling |
Label is not available on this site. |
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08/06/2004 | SUPPL-5 | Labeling |
Label is not available on this site. |
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05/20/2002 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
02/18/2000 | SUPPL-3 | Labeling |
Label is not available on this site. |
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07/21/1999 | SUPPL-1 | Labeling |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
02/24/1999 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/anda/99/75-188_Amiodarone%20Hydrochloride_prntlbl.pdf |