Drug Master Files for: albuterol
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albuterol Drug Master Files
DMF No. | Status | Type | Submission Date | Holder | Subject |
---|---|---|---|---|---|
10253 | A | II | 5/12/1993 | NEULAND LABORATORIES LTD | BENZYL ALBUTEROL, INTERMEDIATE |
10254 | I | II | 5/12/1993 | NEULAND LABORATORIES LTD | ALBUTEROL SULFATE |
13840 | I | III | 11/12/1998 | COURTAULDS PACKAGING LTD | ALBUTEROL 300 DOSE ACTUATOR PROJECT |
14258 | A | II | 6/25/1999 | BOEHRINGER INGELHEIM PHARMA GMBH AND CO KG | ALBUTEROL SULFATE (UNMICRONIZED) |
16104 | A | II | 8/16/2002 | NEULAND LABORATORIES LTD | ALBUTEROL 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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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