Details for New Drug Application (NDA): 202288
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NDA 202288 describes LITHIUM CARBONATE, which is a drug marketed by Able, Alembic Ltd, Apotex Inc, Glenmark Pharms Ltd, Hetero Labs Ltd Iii, Hikma, Norvium Bioscience, Usl Pharma, Watson Labs, Alembic, Glenmark Pharms Inc, Heritage Pharma, Hikma Intl Pharms, Mylan Pharms Inc, Unique, Pfizer, and Sun Pharm Inds Inc, and is included in twenty-nine NDAs. It is available from twenty-three suppliers. Additional details are available on the LITHIUM CARBONATE profile page.
The generic ingredient in LITHIUM CARBONATE is lithium carbonate. There are fifteen drug master file entries for this compound. Twenty-four suppliers are listed for this compound. Additional details are available on the lithium carbonate profile page.
The generic ingredient in LITHIUM CARBONATE is lithium carbonate. There are fifteen drug master file entries for this compound. Twenty-four suppliers are listed for this compound. Additional details are available on the lithium carbonate profile page.
Summary for 202288
| Tradename: | LITHIUM CARBONATE |
| Applicant: | Mylan Pharms Inc |
| Ingredient: | lithium carbonate |
| Patents: | 0 |
Suppliers and Packaging for NDA: 202288
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| LITHIUM CARBONATE | lithium carbonate | TABLET, EXTENDED RELEASE;ORAL | 202288 | ANDA | Mylan Pharmaceuticals Inc. | 0378-1300 | 0378-1300-01 | 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-1300-01) |
| LITHIUM CARBONATE | lithium carbonate | TABLET, EXTENDED RELEASE;ORAL | 202288 | ANDA | Mylan Pharmaceuticals Inc. | 0378-1300 | 0378-1300-05 | 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-1300-05) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 300MG | ||||
| Approval Date: | Jun 29, 2012 | TE: | AB | RLD: | No | ||||
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