Hikma Pharmaceuticals USA Inc |
00054962857 |
Sodium Oxybate Oral Solution 500 MG/ML, 180 ML Bottle |
Generic |
FDA |
2023-01-01 |
5535.0000 |
This drug is a generic product; therefore no marketing and pricing plans are available. This product is sold in the United States only. |
None |
200000 |
None |
None |
None |
None |
None |
None |
Pursuant to CA Health & Safety Code §127681 (c), Hikma is limiting its response to that which is otherwise in the public domain or publicly available. Hikma did not acquire this product.
Hikma has not evaluated the volume of patients in the USA. Sodium Oxybate oral solution is indicated for the treatment of cataplexy or excessive daytime sleepiness (EDS) in patients 7 years of age an older with narcolepsy. According to the National Institute of Neurological Disorders and Stroke, approximately 135,000 to 200,000 people in the U.S. have narcolepsy. |
None |
Hikma Pharmaceuticals USA Inc |
00054043825 |
Levorphanol Tartrate Tablets, 2mg USP, CII, 1 bottle of 100 |
Generic |
FDA |
2023-02-02 |
3337.5000 |
This drug is a generic product; therefore no marketing and pricing plans are available. This product is sold in the United States only. |
None |
110000000 |
None |
None |
2022-11-30 |
None |
1 |
Hikma manufactured this product for Sentynl pursuant to a CMO relationship. Hikma, who acquired Roxane, now has re-acquired the ANDA and has transitioned this product back to Hikma owned and Hikma labeling. |
Pursuant to CA Health & Safety Code §127681 (c), Hikma is limiting its response to that which is otherwise in the public domain or publicly available.
Hikma has not evaluated the volume of patients in the USA. Levorphanol Tartrate is indicated for the management of pain severe enough to require an opioid analgesic. According to the CDC, 1/3 of the US population have received an opioid prescription, therefore approximately 110,000,000. |
None |
Hikma Pharmaceuticals USA Inc |
00054044949 |
Posaconazole Oral Suspension, 200mg/5mL, 105mL bottle |
Generic |
FDA |
2023-03-29 |
1312.8700 |
This drug is a generic product; therefore no marketing and pricing plans are available. This product is sold in the United States only. |
None |
25000 |
None |
None |
None |
None |
None |
None |
Pursuant to CA Health & Safety Code §127681 (c), Hikma is limiting its response to that which is otherwise in the public domain or publicly available. Hikma did not acquire this product.
Hikma has not evaluated the volume of patients in the USA. Posaconazole is indicated for the treatment of oropharyngeal candidiasis. According to the CDC, approximately 25,000 cases of candidemia occur nationwide each year. |
None |
Hikma Pharmaceuticals USA Inc |
00054037025 |
Lisdexamfetamine Dimesylate Capsules, CII, 20mg, 1 bottle of 100 |
Generic |
FDA |
2023-08-25 |
1052.5500 |
This drug is a generic product; therefore no marketing and pricing plans are available. This product is sold in the United States only. |
None |
8700000 |
None |
None |
None |
None |
None |
None |
Pursuant to CA Health & Safety Code §127681 (c), Hikma is limiting its response to that which is otherwise in the public domain or publicly available. Hikma did not acquire this product.
Hikma has not evaluated the volume of patients in the USA. Lisdexamfetamine dimesylate is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older and moderate to severe binge eating disorder in adults. According to the Journal of Managed Care and Specialty Pharmacy, an estimated 8.7 million adults live with ADHD in the United States. |
None |
Hikma Pharmaceuticals USA Inc |
00054037125 |
Lisdexamfetamine Dimesylate Capsules, CII, 30mg, 1 bottle of 100 |
Generic |
FDA |
2023-08-25 |
1052.5500 |
This drug is a generic product; therefore no marketing and pricing plans are available. This product is sold in the United States only. |
None |
8700000 |
None |
None |
None |
None |
None |
None |
Pursuant to CA Health & Safety Code §127681 (c), Hikma is limiting its response to that which is otherwise in the public domain or publicly available. Hikma did not acquire this product.
Hikma has not evaluated the volume of patients in the USA. Lisdexamfetamine dimesylate is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older and moderate to severe binge eating disorder in adults. According to the Journal of Managed Care and Specialty Pharmacy, an estimated 8.7 million adults live with ADHD in the United States. |
None |
Hikma Pharmaceuticals USA Inc |
00054037225 |
Lisdexamfetamine Dimesylate Capsules, CII, 40mg, 1 bottle of 100 |
Generic |
FDA |
2023-08-25 |
1052.5500 |
This drug is a generic product; therefore no marketing and pricing plans are available. This product is sold in the United States only. |
None |
8700000 |
None |
None |
None |
None |
None |
None |
Pursuant to CA Health & Safety Code §127681 (c), Hikma is limiting its response to that which is otherwise in the public domain or publicly available. Hikma did not acquire this product.
Hikma has not evaluated the volume of patients in the USA. Lisdexamfetamine dimesylate is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older and moderate to severe binge eating disorder in adults. According to the Journal of Managed Care and Specialty Pharmacy, an estimated 8.7 million adults live with ADHD in the United States. |
None |
Hikma Pharmaceuticals USA Inc |
00054037325 |
Lisdexamfetamine Dimesylate Capsules, CII, 50mg, 1 bottle of 100 |
Generic |
FDA |
2023-08-25 |
1052.5500 |
This drug is a generic product; therefore no marketing and pricing plans are available. This product is sold in the United States only. |
None |
8700000 |
None |
None |
None |
None |
None |
None |
Pursuant to CA Health & Safety Code §127681 (c), Hikma is limiting its response to that which is otherwise in the public domain or publicly available. Hikma did not acquire this product.
Hikma has not evaluated the volume of patients in the USA. Lisdexamfetamine dimesylate is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older and moderate to severe binge eating disorder in adults. According to the Journal of Managed Care and Specialty Pharmacy, an estimated 8.7 million adults live with ADHD in the United States. |
None |
Hikma Pharmaceuticals USA Inc |
00054037425 |
Lisdexamfetamine Dimesylate Capsules, CII, 60mg, 1 bottle of 100 |
Generic |
FDA |
2023-08-25 |
1052.5500 |
This drug is a generic product; therefore no marketing and pricing plans are available. This product is sold in the United States only. |
None |
8700000 |
None |
None |
None |
None |
None |
None |
Pursuant to CA Health & Safety Code §127681 (c), Hikma is limiting its response to that which is otherwise in the public domain or publicly available. Hikma did not acquire this product.
Hikma has not evaluated the volume of patients in the USA. Lisdexamfetamine dimesylate is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older and moderate to severe binge eating disorder in adults. According to the Journal of Managed Care and Specialty Pharmacy, an estimated 8.7 million adults live with ADHD in the United States. |
None |
Hikma Pharmaceuticals USA Inc |
00054037525 |
Lisdexamfetamine Dimesylate Capsules, CII, 70mg, 1 bottle of 100 |
Generic |
FDA |
2023-08-25 |
1052.5500 |
This drug is a generic product; therefore no marketing and pricing plans are available. This product is sold in the United States only. |
None |
8700000 |
None |
None |
None |
None |
None |
None |
Pursuant to CA Health & Safety Code §127681 (c), Hikma is limiting its response to that which is otherwise in the public domain or publicly available. Hikma did not acquire this product.
Hikma has not evaluated the volume of patients in the USA. Lisdexamfetamine dimesylate is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older and moderate to severe binge eating disorder in adults. According to the Journal of Managed Care and Specialty Pharmacy, an estimated 8.7 million adults live with ADHD in the United States. |
None |