Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 091528
Company: NOVEL LABS INC
Company: NOVEL LABS INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE | HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE | 1.5MG;5MG | TABLET;ORAL | Prescription | AA | No | 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 |
|---|---|---|---|---|---|---|---|
| 04/20/2011 | 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 |
|---|---|---|---|---|---|
| 06/28/2018 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/13/2017 | SUPPL-1 | Labeling-Package Insert |
Label is not available on this site. |
HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE
TABLET;ORAL; 1.5MG;5MG
TE Code = AA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE | HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE | 1.5MG;5MG | TABLET;ORAL | Prescription | No | AA | 207176 | AVANTHI INC |
| HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE | HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE | 1.5MG;5MG | TABLET;ORAL | Prescription | No | AA | 091528 | NOVEL LABS INC |
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