Details for New Drug Application (NDA): 207724
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The generic ingredient in PROGESTERONE is progesterone. There are fifty-seven drug master file entries for this compound. Twenty-five suppliers are listed for this compound. Additional details are available on the progesterone profile page.
Summary for 207724
Tradename: | PROGESTERONE |
Applicant: | Amneal Pharms Ny |
Ingredient: | progesterone |
Patents: | 0 |
Suppliers and Packaging for NDA: 207724
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
PROGESTERONE | progesterone | CAPSULE;ORAL | 207724 | ANDA | Amneal Pharmaceuticals LLC | 65162-807 | 65162-807-10 | 100 CAPSULE in 1 BOTTLE (65162-807-10) |
PROGESTERONE | progesterone | CAPSULE;ORAL | 207724 | ANDA | Amneal Pharmaceuticals LLC | 65162-807 | 65162-807-50 | 500 CAPSULE in 1 BOTTLE (65162-807-50) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 100MG | ||||
Approval Date: | Sep 7, 2017 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 200MG | ||||
Approval Date: | Sep 7, 2017 | TE: | AB | RLD: | No |
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