Details for New Drug Application (NDA): 211913
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The generic ingredient in ABSORICA LD is isotretinoin. There are thirteen drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the isotretinoin profile page.
Summary for 211913
Tradename: | ABSORICA LD |
Applicant: | Sun Pharm |
Ingredient: | isotretinoin |
Patents: | 2 |
Suppliers and Packaging for NDA: 211913
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ABSORICA LD | isotretinoin | CAPSULE;ORAL | 211913 | NDA | Sun Pharmaceutical Industries, Inc. | 10631-002 | 10631-002-31 | 3 BLISTER PACK in 1 BOX (10631-002-31) / 10 CAPSULE in 1 BLISTER PACK |
ABSORICA LD | isotretinoin | CAPSULE;ORAL | 211913 | NDA | Sun Pharmaceutical Industries, Inc. | 10631-003 | 10631-003-31 | 3 BLISTER PACK in 1 BOX (10631-003-31) / 10 CAPSULE in 1 BLISTER PACK |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 8MG | ||||
Approval Date: | Nov 5, 2019 | TE: | RLD: | Yes | |||||
Patent: | ⤷ Sign Up | Patent Expiration: | Aug 4, 2035 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Patent: | ⤷ Sign Up | Patent Expiration: | May 29, 2035 | Product Flag? | Y | Substance Flag? | Delist Request? |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 16MG | ||||
Approval Date: | Nov 5, 2019 | TE: | RLD: | Yes | |||||
Patent: | ⤷ Sign Up | Patent Expiration: | Aug 4, 2035 | Product Flag? | Y | Substance Flag? | Delist Request? |
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