Details for New Drug Application (NDA): 091404
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The generic ingredient in MEROPENEM is meropenem. There are thirty-two drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the meropenem profile page.
Summary for 091404
Tradename: | MEROPENEM |
Applicant: | Acs Dobfar |
Ingredient: | meropenem |
Patents: | 0 |
Suppliers and Packaging for NDA: 091404
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
MEROPENEM | meropenem | INJECTABLE;INJECTION | 091404 | ANDA | Hospira, Inc. | 0409-0222 | 0409-0222-10 | 10 VIAL in 1 CARTON (0409-0222-10) / 10 mL in 1 VIAL (0409-0222-01) |
MEROPENEM | meropenem | INJECTABLE;INJECTION | 091404 | ANDA | Hospira, Inc. | 0409-1390 | 0409-1390-51 | 10 VIAL in 1 CARTON (0409-1390-51) / 10 mL in 1 VIAL (0409-1390-21) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 500MG/VIAL | ||||
Approval Date: | Oct 26, 2011 | TE: | AP | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 1GM/VIAL | ||||
Approval Date: | Oct 26, 2011 | TE: | AP | RLD: | No |
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