← FDA DRUG APPROVALS

FDA NDA · NDA017558

GLYCOPYRROLATE

Sponsor: HIKMA

APPLICATION
NDA017558
TYPE
NDA
ORIGINAL APPROVAL
1975-02-06
LATEST ACTION
2026-02-24
ROUTE
INTRAMUSCULAR, INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

ROBINUL · ReferencePrescription
GLYCOPYRROLATE 0.2MG/ML · INJECTABLE · INJECTION

Approval history

2026-02-24Labeling · Supplement 66 · standard — Label ↗AP
2025-09-25Manufacturing (CMC) · Supplement 69 — Label ↗AP
2025-07-16Efficacy · Supplement 68 · standard — Letter ↗AP
2024-07-12Manufacturing (CMC) · Supplement 63 — Letter ↗AP
2018-07-05Labeling · Supplement 62 · standard — Letter ↗AP
2014-03-18Manufacturing (CMC) · Supplement 60 · standardAP
2005-05-26Labeling · Supplement 53 · standard — Letter ↗AP
2004-11-05Labeling · Supplement 46 · standard — Letter ↗AP
2004-11-05Labeling · Supplement 50 · standard — Letter ↗AP
2004-11-05Labeling · Supplement 49 · standard — Letter ↗AP
2004-11-05Labeling · Supplement 45 · standard — Letter ↗AP
2003-06-30Labeling · Supplement 48 · standard — Letter ↗AP
2003-06-30Labeling · Supplement 47 · standard — Letter ↗AP
2001-04-26Manufacturing (CMC) · Supplement 43 · standardAP
1998-02-13Manufacturing (CMC) · Supplement 42 · standardAP
1988-09-06Manufacturing (CMC) · Supplement 41 · standardAP
1988-06-06Manufacturing (CMC) · Supplement 40 · standardAP
1988-04-18Manufacturing (CMC) · Supplement 39 · standardAP
1987-03-16Manufacturing (CMC) · Supplement 38 · standardAP
1986-07-24Manufacturing (CMC) · Supplement 35 · standardAP
1986-06-12Manufacturing (CMC) · Supplement 36 · standardAP
1986-06-12Manufacturing (CMC) · Supplement 37 · standardAP
1983-03-02Manufacturing (CMC) · Supplement 29 · standardAP
1983-03-02Manufacturing (CMC) · Supplement 30 · standardAP
1982-03-04Manufacturing (CMC) · Supplement 28 · standardAP
1982-01-19Manufacturing (CMC) · Supplement 27 · standardAP
1981-11-06Manufacturing (CMC) · Supplement 26 · standardAP
1981-10-22Labeling · Supplement 23AP
1981-10-22Labeling · Supplement 24AP
1981-10-22Manufacturing (CMC) · Supplement 22 · standardAP
1981-09-24Manufacturing (CMC) · Supplement 25 · standardAP
1980-12-04Labeling · Supplement 18AP
1980-09-26Manufacturing (CMC) · Supplement 19 · standardAP
1980-04-01Labeling · Supplement 17AP
1980-04-01Labeling · Supplement 15AP
1980-04-01Manufacturing (CMC) · Supplement 16 · standardAP
1980-04-01Manufacturing (CMC) · Supplement 14 · standardAP
1978-11-30Manufacturing (CMC) · Supplement 11 · standardAP
1978-08-17Labeling · Supplement 9AP
1978-08-17Labeling · Supplement 10AP
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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