Details for New Drug Application (NDA): 205883
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The generic ingredient in MEROPENEM is meropenem. There are thirty-two drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the meropenem profile page.
Summary for 205883
Tradename: | MEROPENEM |
Applicant: | Amneal Pharms |
Ingredient: | meropenem |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 205883
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
MEROPENEM | meropenem | INJECTABLE;INJECTION | 205883 | ANDA | BluePoint Laboratories | 68001-323 | 68001-323-31 | 10 VIAL, GLASS in 1 CARTON (68001-323-31) / 20 mL in 1 VIAL, GLASS (68001-323-29) |
MEROPENEM | meropenem | INJECTABLE;INJECTION | 205883 | ANDA | BluePoint Laboratories | 68001-324 | 68001-324-57 | 10 VIAL, GLASS in 1 CARTON (68001-324-57) / 30 mL in 1 VIAL, GLASS (68001-324-58) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 500MG/VIAL | ||||
Approval Date: | Apr 12, 2016 | TE: | AP | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 1GM/VIAL | ||||
Approval Date: | Apr 12, 2016 | TE: | AP | RLD: | No |
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