General MedicationsTOPICALGeneric

LAC-HYDRIN

AMMONIUM LACTATE

Standard Dose

EQ 12% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Max Dose

Refer to approved labeling

Primary Use

Review priority: STANDARD Marketing status: Discontinued

Summary

Approval overview LAC-HYDRIN is listed in Drugs@FDA under application 019155 (NDA).

Review priority: STANDARD Marketing status: Discontinued Active ingredient AMMONIUM LACTATE Form and strength LOTION;TOPICAL - EQ 12% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Sponsor SUN PHARM INDS INC Submission history Latest submission status date: 2013-04-02 00:00:00.

Structured Monograph

Clinical summary

Approval overview LAC-HYDRIN is listed in Drugs@FDA under application 019155 (NDA). Review priority: STANDARD Marketing status: Discontinued Active ingredient AMMONIUM LACTATE Form and strength LOTION;TOPICAL - EQ 12% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Sponsor SUN PHARM INDS INC Submission history Latest submission status date: 2013-04-02 00:00:00. Submission type: SUPPL.

Monitoring

• Marketing status: Discontinued
• Review priority: STANDARD

Interaction Notes

No interaction notes stored yet.