Details for New Drug Application (NDA): 050138
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NDA 050138 describes BICILLIN C-R 900/300, which is a drug marketed by King Pharms Llc and is included in one NDA. It is available from one supplier. Additional details are available on the BICILLIN C-R 900/300 profile page.
The generic ingredient in BICILLIN C-R 900/300 is penicillin g benzathine; penicillin g procaine. There are ninety-two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the penicillin g benzathine; penicillin g procaine profile page.
The generic ingredient in BICILLIN C-R 900/300 is penicillin g benzathine; penicillin g procaine. There are ninety-two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the penicillin g benzathine; penicillin g procaine profile page.
Summary for 050138
| Tradename: | BICILLIN C-R 900/300 |
| Applicant: | King Pharms Llc |
| Ingredient: | penicillin g benzathine; penicillin g procaine |
| Patents: | 0 |
Suppliers and Packaging for NDA: 050138
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| BICILLIN C-R | penicillin g benzathine; penicillin g procaine | INJECTABLE;INJECTION | 050138 | NDA | Pfizer Laboratories Div Pfizer Inc | 60793-600 | 60793-600-10 | 10 SYRINGE in 1 PACKAGE (60793-600-10) / 2 mL in 1 SYRINGE (60793-600-02) |
| BICILLIN C-R | penicillin g benzathine; penicillin g procaine | INJECTABLE;INJECTION | 050138 | NDA | Pfizer Laboratories Div Pfizer Inc | 60793-601 | 60793-601-10 | 10 SYRINGE in 1 PACKAGE (60793-601-10) / 2 mL in 1 SYRINGE (60793-601-02) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 300,000 UNITS/ML;300,000 UNITS/ML | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | Yes | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | 150,000 UNITS/ML;150,000 UNITS/ML | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | Yes | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 900,000 UNITS/2ML;300,000 UNITS/2ML | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | Yes | |||||
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