Details for New Drug Application (NDA): 216154
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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 216154
Tradename: | MEROPENEM |
Applicant: | Brooks Steriscience |
Ingredient: | meropenem |
Patents: | 0 |
Suppliers and Packaging for NDA: 216154
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
MEROPENEM | meropenem | INJECTABLE;INJECTION | 216154 | ANDA | ARMAS PHARMACEUTICALS INC | 72485-411 | 72485-411-01 | 1 VIAL in 1 CARTON (72485-411-01) / 20 mL in 1 VIAL |
MEROPENEM | meropenem | INJECTABLE;INJECTION | 216154 | ANDA | ARMAS PHARMACEUTICALS INC | 72485-411 | 72485-411-10 | 10 VIAL in 1 CARTON (72485-411-10) / 20 mL in 1 VIAL |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 500MG/VIAL | ||||
Approval Date: | Aug 18, 2022 | TE: | AP | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 1GM/VIAL | ||||
Approval Date: | Aug 18, 2022 | TE: | AP | RLD: | No |
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