Details for New Drug Application (NDA): 210773
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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 210773
Tradename: | MEROPENEM |
Applicant: | Hq Spclt Pharma |
Ingredient: | meropenem |
Patents: | 0 |
Suppliers and Packaging for NDA: 210773
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
MEROPENEM | meropenem | INJECTABLE;INJECTION | 210773 | ANDA | WG Critical Care, LLC | 44567-145 | 44567-145-10 | 10 VIAL in 1 CARTON (44567-145-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (44567-145-01) |
MEROPENEM | meropenem | INJECTABLE;INJECTION | 210773 | ANDA | WG Critical Care, LLC | 44567-146 | 44567-146-10 | 10 VIAL in 1 CARTON (44567-146-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (44567-146-01) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 500MG/VIAL | ||||
Approval Date: | Aug 16, 2019 | TE: | AP | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 1GM/VIAL | ||||
Approval Date: | Aug 16, 2019 | TE: | AP | RLD: | No |
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