Drugs@FDA: FDA Approved Drug Products
Abbreviated New Drug Application (ANDA): 074077
Company: HI TECH PHARMA
Company: HI TECH PHARMA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| LACTULOSE | 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 |
|---|---|---|---|---|---|---|---|
| 07/03/1995 | 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 |
|---|---|---|---|---|---|
| 09/04/2009 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 05/05/2009 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 10/09/1997 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/09/1997 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/09/1997 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
LACTULOSE
SOLUTION;ORAL, RECTAL; 10GM/15ML
TE Code = AA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CHOLAC | LACTULOSE | 10GM/15ML | SOLUTION;ORAL, RECTAL | Prescription | No | AA | 071331 | ALRA |
| ENULOSE | LACTULOSE | 10GM/15ML | SOLUTION;ORAL, RECTAL | Prescription | No | AA | 071548 | ACTAVIS MID ATLANTIC |
| GENERLAC | LACTULOSE | 10GM/15ML | SOLUTION;ORAL, RECTAL | Prescription | No | AA | 074603 | WOCKHARDT BIO AG |
| LACTULOSE | LACTULOSE | 10GM/15ML | SOLUTION;ORAL, RECTAL | Prescription | No | AA | 090426 | ANI PHARMS |
| LACTULOSE | LACTULOSE | 10GM/15ML | SOLUTION;ORAL, RECTAL | Prescription | No | AA | 090502 | FRESENIUS KABI |
| LACTULOSE | LACTULOSE | 10GM/15ML | SOLUTION;ORAL, RECTAL | Prescription | No | AA | 074077 | HI TECH PHARMA |
| LACTULOSE | LACTULOSE | 10GM/15ML | SOLUTION;ORAL, RECTAL | Prescription | No | AA | 203762 | TORRENT |
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