FDA BLA · BLA050114

PRE-PEN

benzylpenicilloyl polylysine

Sponsor: ALLERQUEST

APPLICATION

BLA050114

TYPE

BLA

ORIGINAL APPROVAL

1974-07-25

LATEST ACTION

2023-01-18

ROUTE

INTRADERMAL, SUBCUTANEOUS, INJECTION

DOSAGE FORM

INJECTABLE

MARKETING STATUS

Prescription

Products

PRE-PENPrescription

BENZYLPENICILLOYL POLYLYSINE 60UMOLAR · INJECTABLE · INJECTION

2023-01-18Labeling · Supplement 10 · standard — Letter ↗AP

2009-09-18Manufacturing (CMC) · Supplement 8 — Letter ↗AP

2000-04-06Manufacturing (CMC) · Supplement 7 · standardAP

1989-03-30Manufacturing (CMC) · Supplement 5 · standardAP

1981-12-02Manufacturing (CMC) · Supplement 4 · standardAP

1978-11-28Manufacturing (CMC) · Supplement 3 · standardAP

1976-02-09Manufacturing (CMC) · Supplement 2 · standardAP

1974-10-30Manufacturing (CMC) · Supplement 1 · standardAP

1974-07-25Type 1 - New Molecular Entity · Original · standardAP

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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