Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 088008
Company: WOCKHARDT BIO AG
Company: WOCKHARDT BIO AG
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE | HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE | 1.5MG/5ML;5MG/5ML | SYRUP;ORAL | Prescription | AA | 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 |
|---|---|---|---|---|---|---|---|
| 03/03/1983 | 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-18 | Labeling-Package Insert |
Label is not available on this site. |
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| 01/13/2017 | SUPPL-17 | Labeling-Package Insert |
Label is not available on this site. |
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| 02/13/1996 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/10/1996 | SUPPL-13 | Labeling |
Label is not available on this site. |
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| 03/25/1994 | SUPPL-12 | Labeling |
Label is not available on this site. |
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| 12/27/1989 | SUPPL-11 | Labeling |
Label is not available on this site. |
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| 07/12/1989 | SUPPL-10 | Labeling |
Label is not available on this site. |
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| 07/12/1989 | SUPPL-9 | Labeling |
Label is not available on this site. |
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| 04/05/1989 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
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| 10/20/1988 | SUPPL-7 | Labeling |
Label is not available on this site. |
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| 07/28/1988 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/24/1987 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/24/1987 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/24/1987 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/05/1986 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE
SYRUP;ORAL; 1.5MG/5ML;5MG/5ML
TE Code = AA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| HYCODAN | HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE | 1.5MG/5ML;5MG/5ML | SYRUP;ORAL | Prescription | Yes | AA | 005213 | GENUS |
| HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE | HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE | 1.5MG/5ML;5MG/5ML | SYRUP;ORAL | Prescription | No | AA | 207487 | ABHAI LLC |
| HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE | HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE | 1.5MG/5ML;5MG/5ML | SYRUP;ORAL | Prescription | No | AA | 088017 | ACTAVIS MID ATLANTIC |
| HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE | HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE | 1.5MG/5ML;5MG/5ML | SYRUP;ORAL | Prescription | No | AA | 203535 | NOVEL LABS INC |
| HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE | HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE | 1.5MG/5ML;5MG/5ML | SYRUP;ORAL | Prescription | No | AA | 205731 | PADAGIS US |
| HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE | HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE | 1.5MG/5ML;5MG/5ML | SYRUP;ORAL | Prescription | No | AA | 088008 | WOCKHARDT BIO AG |