Application 201952
- Type
- ANDA
- Sponsor
- MICRO LABS LTD INDIA
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN | ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE | TABLET;ORAL | 325MG;37.5MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 42571-119 | TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN | TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN | Micro Labs Limited | ANDA | Current |
| 42571-119 | TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN | TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN | Micro Labs Limited | ANDA | Current |
| 42571-119 | TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN | TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN | Micro Labs Limited | ANDA | Current |
| 42571-119 | TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN | TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN | Micro Labs Limited | ANDA | Current |
| 42571-119 | TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN | TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN | Micro Labs Limited | ANDA | Current |
| 68788-7712 | TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN | TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-7712 | TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN | TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 70518-2784 | TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN | TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN | REMEDYREPACK INC. | ANDA | Current |
| 70518-2784 | TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN | TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN | REMEDYREPACK INC. | ANDA | Current |
| 76420-105 | TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN | TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN | Asclemed USA, Inc. | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 76114 | ORIG | 2023-11-02 |