Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 205043
Company: ACS DOBFAR SPA
Company: ACS DOBFAR SPA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
PENICILLIN G POTASSIUM | PENICILLIN G POTASSIUM | 5,000,000 UNITS/VIAL | INJECTABLE;INJECTION | Prescription | AP | No | No |
PENICILLIN G POTASSIUM | PENICILLIN G POTASSIUM | 20,000,000 UNITS/VIAL | INJECTABLE;INJECTION | Prescription | AP | No | No |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
10/26/2018 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
PENICILLIN G POTASSIUM
INJECTABLE;INJECTION; 5,000,000 UNITS/VIAL
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
PENICILLIN G POTASSIUM | PENICILLIN G POTASSIUM | 5,000,000 UNITS/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 205043 | ACS DOBFAR SPA |
PENICILLIN G POTASSIUM | PENICILLIN G POTASSIUM | 5,000,000 UNITS/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 065149 | HQ SPECLT PHARMA |
PENICILLIN G POTASSIUM | PENICILLIN G POTASSIUM | 5,000,000 UNITS/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 065448 | ISTITUTO BIO ITA SPA |
PENICILLIN G POTASSIUM | PENICILLIN G POTASSIUM | 5,000,000 UNITS/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 065079 | SANDOZ |
PFIZERPEN | PENICILLIN G POTASSIUM | 5,000,000 UNITS/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 060657 | PFIZER |
INJECTABLE;INJECTION; 20,000,000 UNITS/VIAL
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
PENICILLIN G POTASSIUM | PENICILLIN G POTASSIUM | 20,000,000 UNITS/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 205043 | ACS DOBFAR SPA |
PENICILLIN G POTASSIUM | PENICILLIN G POTASSIUM | 20,000,000 UNITS/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 065149 | HQ SPECLT PHARMA |
PENICILLIN G POTASSIUM | PENICILLIN G POTASSIUM | 20,000,000 UNITS/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 065448 | ISTITUTO BIO ITA SPA |
PENICILLIN G POTASSIUM | PENICILLIN G POTASSIUM | 20,000,000 UNITS/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 065079 | SANDOZ |
PFIZERPEN | PENICILLIN G POTASSIUM | 20,000,000 UNITS/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 060657 | PFIZER |