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Athena Athena

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List of Drug Master Files (DMF) for 16433 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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01 Alkermes Plc (1)

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01 AVINZA((R) (MORPHINE SULFATE EXTENDED-RELEASE CAPSULES) 30MG, 45MG, 60MG, 75MG, 90MG AND 120MG (1)

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01 Ireland (1)

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01 Inactive (1)

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01 Blank (1)

URL Supplier Web Content
16433
Inactive
2003-02-21
N/A
II
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Looking for Drug Master Files (DMF) for 16433 of Alkermes Inc

Looking for Drug Master Files (DMF) for 16433 of Alkermes Inc 1

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Alkermes Inc, based in Ireland, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

One of their notable products is AVINZA((R) (MORPHINE SULFATE EXTENDED-RELEASE CAPSULES) 30MG, 45MG, 60MG, 75MG, 90MG AND 120MG, with a corresponding US DMF Number 16433.

Remarkably, this DMF maintains an Inactive status since its submission on February 21, 2003, highlighting commitment to regulatory compliance.

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