Drugs@FDA: FDA-Approved Drugs
Company: VISTAPHARM
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| LACTULOSE | LACTULOSE | 10GM/15ML | SOLUTION;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 |
|---|---|---|---|---|---|---|---|
| 09/30/1992 | 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 |
|---|---|---|---|---|---|
| 11/28/2001 | SUPPL-13 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 03/27/2000 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/22/1997 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/22/1997 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/24/1998 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 01/31/1997 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 01/31/1997 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/20/1996 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 08/07/1996 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 08/07/1996 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/07/1996 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/22/1994 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
LACTULOSE
SOLUTION;ORAL; 10GM/15ML
TE Code = AA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CONSTILAC | LACTULOSE | 10GM/15ML | SOLUTION;ORAL | Prescription | No | AA | 071054 | ALRA |
| LACTULOSE | LACTULOSE | 10GM/15ML | SOLUTION;ORAL | Prescription | No | AA | 074076 | AKORN |
| LACTULOSE | LACTULOSE | 10GM/15ML | SOLUTION;ORAL | Prescription | No | AA | 209517 | CHARTWELL RX |
| LACTULOSE | LACTULOSE | 10GM/15ML | SOLUTION;ORAL | Prescription | No | AA | 090503 | FRESENIUS KABI |
| LACTULOSE | LACTULOSE | 10GM/15ML | SOLUTION;ORAL | Prescription | No | AA | 075993 | LANNETT CO INC |
| LACTULOSE | LACTULOSE | 10GM/15ML | SOLUTION;ORAL | Prescription | No | AA | 074623 | PHARM ASSOC |
| LACTULOSE | LACTULOSE | 10GM/15ML | SOLUTION;ORAL | Prescription | No | AA | 074138 | VISTAPHARM |
| LACTULOSE | LACTULOSE | 10GM/15ML | SOLUTION;ORAL | Prescription | No | AA | 074602 | WOCKHARDT BIO AG |
| LACTULOSE | LACTULOSE | 10GM/15ML | SOLUTION;ORAL | Prescription | No | AA | 075911 | XTTRIUM LABS INC |
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