Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075618
Company: HIKMA INTL PHARMS
Company: HIKMA INTL PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE | ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE | 325MG;50MG;40MG;30MG | CAPSULE;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 |
|---|---|---|---|---|---|---|---|
| 03/23/2001 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75618ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 09/18/2018 | SUPPL-27 | REMS - PROPOSAL - D-N-A |
Label is not available on this site. |
||
| 06/01/2017 | SUPPL-25 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 06/01/2015 | SUPPL-23 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
| 08/01/2014 | SUPPL-21 | Labeling-Package Insert |
Label is not available on this site. |
||
| 07/08/2011 | SUPPL-19 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/08/2009 | SUPPL-17 | Labeling |
Label is not available on this site. |
||
| 11/07/2007 | SUPPL-15 | Labeling |
Label is not available on this site. |
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| 12/29/2003 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 01/26/2008 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/25/2002 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |