Issued to KING PHARMS LLC. Application is approved as submitted.
Issued
June 29, 2026Application
NDA 505b1 • 050138
Product
BICILLIN C-R / BICILLIN C-R 900/300 / BICILLIN L-A
Company
KING PHARMS LLC
Stage
Final Decision
Assyro regulatory brief
FreeSource facts and Assyro context are separated so you can scan the action quickly without treating analysis as an FDA conclusion.
FDA issued an approval letter for BICILLIN C-R, BICILLIN C-R 900/300, BICILLIN L-A on 2026-06-29. The source metadata identifies NDA 050138, NDA 050141 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Review the exact FDA letter for approved conditions, labeling, and postmarketing requirements.
Open the document workspaceFDA source document
This letter documents an FDA approval action: FDA approved NDA 050138 for BICILLIN C-R / BICILLIN C-R 900/300 / BICILLIN L-A, sponsored by KING PHARMS LLC, on June 29, 2026. Product may be marketed. Verify current status and labeling in the source letter, since later FDA actions can change them.
NDA 050138 is the application under which FDA issued this approval letter for BICILLIN C-R / BICILLIN C-R 900/300 / BICILLIN L-A to KING PHARMS LLC. The letter is dated June 29, 2026.
The sponsor may market the product in line with the approved labeling. Approval letters typically set post-approval obligations: submitting final content of labeling, meeting any postmarketing requirements or commitments listed in the letter, updating Orange Book patent information within 30 days for NDAs, and ongoing annual reporting under 21 CFR 314.81.