Drug Master Files for: ATROPINE SULFATE
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ATROPINE SULFATE Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 12067 | I | II | 7/23/1996 | BOEHRINGER INGELHEIM PHARMA GMBH AND CO KG | HOMATROPINE HYDROBROMIDE |
| 23963 | A | II | 7/12/2010 | SAURAV CHEMICALS LTD | HOMATROPINE METHYLBROMIDE USP |
| 28423 | A | II | 7/8/2014 | CEDARBURG PHARMACEUTICALS INC | ATROPINE SULFATE, USP |
| 28530 | A | II | 7/28/2014 | HUBEI BIOCAUSE HEILEN PHARMACEUTICAL CO LTD | HOMATROPINE METHYLBROMIDE |
| 28978 | A | II | 12/25/2014 | HUBEI BIOCAUSE HEILEN PHARMACEUTICAL CO LTD | ATROPINE SULFATE |
| 29396 | A | II | 5/25/2015 | ROLABO OUTSOURCING SL | ATROPINE SULFATE USP |
| >DMF No. | >Status | >Type | >Submission Date | >Holder | >Subject |
Drug Master File Glossary
STATUS OF DMFS
- A = Active. This means that the DMF was found acceptable for filing, administratively, and is up-to-date.
- I = Inactive
- N = Not an assigned number
- P = DMF Pending Filing Review
TYPES OF DMFs
- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)
- Type II Drug Substance, Drug Substance Intermediate, and Material Used in Their Preparation, or Drug Product
- Type III Packaging Material
- Type IV Excipient, Colorant, Flavor, Essence, or Material Used in Their Preparation
- Type V FDA Accepted Reference Information
