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FDA NDA · NDA212319

N/A

atropine injection, 2 mg

Sponsor: RAFA LABS LTD

APPLICATION
NDA212319
TYPE
NDA
ORIGINAL APPROVAL
2018-07-09
LATEST ACTION
2023-02-27
ROUTE
INTRAMUSCULAR
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued

Products

ATROPINE (AUTOINJECTOR)Discontinued
ATROPINE EQ 2MG SULFATE/0.7ML (EQ 2MG SULFATE/0.7ML) · SOLUTION · INTRAMUSCULAR

Approval history

2023-02-27Labeling · Supplement 7 · standard — Letter ↗AP
2019-07-09Labeling · Supplement 2 · standard — Letter ↗AP
2018-07-09Type 5 - New Formulation or New Manufacturer · Original · priority — Label ↗AP
VIEW ON DRUGS@FDA ↗

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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