Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 074603
Company: WOCKHARDT BIO AG
Company: WOCKHARDT BIO AG
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
GENERLAC | LACTULOSE | 10GM/15ML | SOLUTION;ORAL, RECTAL | 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 |
---|---|---|---|---|---|---|---|
10/31/1996 | 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 |
---|---|---|---|---|---|
11/26/2001 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
04/05/2001 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
07/15/1999 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
04/14/2000 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
04/14/2000 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
GENERLAC
SOLUTION;ORAL, RECTAL; 10GM/15ML
TE Code = AA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
GENERLAC | LACTULOSE | 10GM/15ML | SOLUTION;ORAL, RECTAL | Prescription | No | AA | 074603 | WOCKHARDT BIO AG |
LACTULOSE | LACTULOSE | 10GM/15ML | SOLUTION;ORAL, RECTAL | Prescription | No | AA | 074077 | AKORN |
LACTULOSE | LACTULOSE | 10GM/15ML | SOLUTION;ORAL, RECTAL | Prescription | No | AA | 090502 | FRESENIUS KABI |
LACTULOSE | LACTULOSE | 10GM/15ML | SOLUTION;ORAL, RECTAL | Prescription | No | AA | 203762 | TORRENT |
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