Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075774
Company: PADAGIS ISRAEL
Company: PADAGIS ISRAEL
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
AMMONIUM LACTATE | AMMONIUM LACTATE | EQ 12% BASE | CREAM;TOPICAL | Prescription | AB | 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 |
---|---|---|---|---|---|---|---|
05/01/2002 | ORIG-1 | Approval |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/075774.PDF |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
06/09/2009 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
12/26/2002 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
12/26/2002 | SUPPL-1 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
AMMONIUM LACTATE
CREAM;TOPICAL; EQ 12% BASE
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
AMMONIUM LACTATE | AMMONIUM LACTATE | EQ 12% BASE | CREAM;TOPICAL | Prescription | No | AB | 075774 | PADAGIS ISRAEL |
AMMONIUM LACTATE | AMMONIUM LACTATE | EQ 12% BASE | CREAM;TOPICAL | Prescription | No | AB | 075883 | TARO |