Details for New Drug Application (NDA): 213829
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The generic ingredient in LEUPROLIDE ACETATE is leuprolide acetate. There are twenty-two drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the leuprolide acetate profile page.
Summary for 213829
Tradename: | LEUPROLIDE ACETATE |
Applicant: | Rk Pharma |
Ingredient: | leuprolide acetate |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Medical Subject Heading (MeSH) Categories for 213829
Suppliers and Packaging for NDA: 213829
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
LEUPROLIDE ACETATE | leuprolide acetate | INJECTABLE;INJECTION | 213829 | ANDA | NorthStar RxLLC | 72603-344 | 72603-344-01 | 1 KIT in 1 CARTON (72603-344-01) * 1 VIAL, MULTI-DOSE in 1 CARTON (72603-201-01) / 2.8 mL in 1 VIAL, MULTI-DOSE * 28 PACKET in 1 CARTON / 1 mL in 1 PACKET |
LEUPROLIDE ACETATE | leuprolide acetate | INJECTABLE;INJECTION | 213829 | ANDA | VGYAAN Pharmaceuticals LLC | 72664-611 | 72664-611-28 | 1 KIT in 1 CARTON (72664-611-28) * 2.8 mL in 1 VIAL, MULTI-DOSE * 1 mL in 1 PACKET |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 1MG/0.2ML | ||||
Approval Date: | Aug 13, 2021 | TE: | AP | RLD: | No |
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