General MedicationsINTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEALStandard

ATROPINE SULFATE

Standard Dose

8MG/20ML (0.4MG/ML)

Max Dose

Refer to approved labeling

Primary Use

Review priority: STANDARD Marketing status: Prescription

Summary

Approval overview ATROPINE SULFATE is listed in Drugs@FDA under application 215005 (ANDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient ATROPINE SULFATE Form and strength SOLUTION;INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEAL - 8MG/20ML (0.4MG/ML) Sponsor SOMERSET THERAPS LLC Submission history Latest submission status date: 2024-11-29 00:00:00.

Structured Monograph

Clinical summary

Approval overview ATROPINE SULFATE is listed in Drugs@FDA under application 215005 (ANDA). Review priority: STANDARD Marketing status: Prescription Active ingredient ATROPINE SULFATE Form and strength SOLUTION;INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEAL - 8MG/20ML (0.4MG/ML) Sponsor SOMERSET THERAPS LLC Submission history Latest submission status date: 2024-11-29 00:00:00. Submission type: ORIG.

Monitoring

• Marketing status: Prescription
• Review priority: STANDARD

Interaction Notes

No interaction notes stored yet.