Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 065079
Company: SANDOZ
Company: SANDOZ
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
PENICILLIN G POTASSIUM | PENICILLIN G POTASSIUM | 1,000,000 UNITS/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | No | No |
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 |
---|---|---|---|---|---|---|---|
08/30/2002 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
09/30/2004 | SUPPL-4 | Labeling |
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 |